Trial Outcomes & Findings for Evaluation of [18F]Fluoroethyl Triazole Labelled [Tyr3]-Octreotate Analogues for the Imaging of Neuroendocrine Tumours. (NCT NCT06456723)

Last Updated: 2025-05-01

Results Overview

Mean residence time (MRT) was used to characterise the biodistribution of \[18F\]-FET-βAG-TOCA throughout the body. Mean residence time is a pharmacokinetic/uptake parameter that describes the average length of time a radiotracer resides within the body, or a particular organ, before being eliminated. Understanding MRT helps researchers to determine how long a radiotracer remains in the system, which is crucial for drug dosing, therapeutic efficacy, and potential toxicity assessment.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

56 participants

Primary outcome timeframe

Baseline (on day of scan over 4 hours)

Results posted on

2025-05-01

Participant Flow

Recruitment Period: 14May2014-17Oct2018. The FETONET study was designed to have 3 parts. Part A evaluated the biodistribution, dosimetry and safety of \[18F\]FET-βAG-TOCA. Uptake was assessed at multiple time points and an optimal time point determined. Part B utilised this time point within a larger cohort. Part C comprised a prospective non-inferiority study analysing the \[18F\]FET-βAG-TOCA PET/CT data collected during Parts A \& B and comparing this to \[Ga68\]Ga-DOTA-peptide PET-CT imaging.

Participant milestones

Participant milestones
Measure	Part A: [18F]-FET-βAG-TOCA-PET/CT Performed in Patients With Histologically-confirmed NET. Patients with histologically-confirmed neuroendocrine tumours (NET) enrolled into Part A of the FETONET study underwent whole-body dynamic \[18F\]-FET-βAG-TOCA PET/CT imaging at multiple time points over a 4 hour period, with sampling of venous bloods for radioactivity and radioactive metabolite quantification. The maximum dose of \[18F\]-FET-βAG-TOCA injected was 165MBq. Imaging Protocol for patients in Part A of the FETONET study: -2 minutes - Low dose attenuation CT. 0 minutes - Injection of \[18F\]-FET-βAG-TOCA (maximum of 165MBq) 0-242 - Dynamic whole body \[18F\]-FET-βAG-TOCA PET-CT (6 sweeps of the body). Following the fourth sweep, the patient had a 20 minutes break. The patient returned to the PET-CT scanner and had a second low-dose attenuation CT scan before completing PET/CT sweeps 5 \& 6. Total effective dose: 12 mSv In Part A of the FETONET study, two low-dose attenuation CT scans were performed per patient. Whereas, only one low-dose attenuation CT scan was performed per patient in Part A. The total effective dose per patient was therefore higher in Part A.	Part B: [18F]-FET-βAG-TOCA-PET/CT Compared With [68Ga]Ga-DOTA-peptide PET/CT in Patients With NET. Patients with histologically confirmed neuroendocrine tumours (NET) underwent PET/CT imaging with both \[18F\]-FET-βAG-TOCA and \[68Ga\]Ga-peptide. The two PET/CT scans were performed within a 6-month time period. Whole-body static \[18F\]-FET-βAG-TOCA PET-CT imaging was conducted 50 minutes post-injection. The maximum dose of \[18F\]-FET-βAG-TOCA injected was 165MBq. Imaging Protocol for patients in Part B of the FETONET study: -2 minutes - Low dose attenuation CT. 0 minutes - Injection of the \[18F\]-FET-βAG-TOCA (Maximum injected dose of 370MBq) * 50 minutes - \[18F\]-FET-βAG-TOCA PET scan 1 * 120 minutes - \[18F\]-FET-βAG-TOCA PET scan 2 Total effective dose: 9 mSv In Part B of the FETONET study, one low-dose attenuation CT scan was performed per patient. Whereas, two low-dose attenuation CT scans were performed per patient in Part A. The total effective dose per patient was therefore lower in Part B.
Part A STARTED	9	0
Part A COMPLETED	9	0
Part A NOT COMPLETED	0	0
Part B STARTED	0	47
Part B COMPLETED	0	47
Part B NOT COMPLETED	0	0
Part C - Primary Analysis STARTED	9	47
Part C - Primary Analysis COMPLETED	9	36
Part C - Primary Analysis NOT COMPLETED	0	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A: [18F]-FET-βAG-TOCA-PET/CT Performed in Patients With Histologically-confirmed NET. n=9 Participants Patients with histologically confirmed neuroendocrine tumours (NET) enrolled into Part A of the FETONET study underwent whole-body dynamic \[18F\]-FET-βAG-TOCA PET/CT imaging at multiple time points over a 4-hour period, with sampling of venous bloods for radioactivity and radioactive metabolite quantification. The maximum dose of \[18F\]-FET-βAG-TOCA injected was 165MBq. Imaging Protocol for patients in Part A of the FETONET study: -2 minutes - Low dose attenuation CT. 0 minutes - Injection of \[18F\]-FET-βAG-TOCA (maximum of 165MBq) 0-242 - Dynamic whole body \[18F\]-FET-βAG-TOCA PET-CT (6 sweeps of the body). Following the fourth sweep, the patient had a 20 minutes break. The patient returned to the PET-CT scanner and had a second low-dose attenuation CT scan before completing PET/CT sweeps 5 \& 6. Total effective dose: 12 mSv In Part A of the FETONET study, two low-dose attenuation CT scans were performed per patient. Whereas, only one low-dose attenuation CT scan was performed per patient in Part A. The total effective dose per patient was therefore higher in Part A.	Part B: [18F]-FET-βAG-TOCA-PET/CT Compared With [68Ga]Ga-DOTA-peptide PET/CT in Patients With NET. n=36 Participants Patients with histologically confirmed neuroendocrine tumours (NET) underwent PET/CT imaging with both \[18F\]-FET-βAG-TOCA and \[68Ga\]Ga-peptide. The two PET/CT scans were performed within a 6-month time period. Whole-body static \[18F\]-FET-βAG-TOCA PET-CT imaging was conducted 50 minutes post-injection. The maximum dose of \[18F\]-FET-βAG-TOCA injected was 165MBq. Imaging Protocol for patients in Part B of the FETONET study: -2 minutes - Low dose attenuation CT. 0 minutes - Injection of the \[18F\]-FET-βAG-TOCA (Maximum injected dose of 370MBq) * 50 minutes - \[18F\]-FET-βAG-TOCA PET scan 1 * 120 minutes - \[18F\]-FET-βAG-TOCA PET scan 2 Total effective dose: 9 mSv In Part B of the FETONET study, one low-dose attenuation CT scan was performed per patient. Whereas, two low-dose attenuation CT scans were performed per patient in Part A. The total effective dose per patient was therefore lower in Part B.	Total n=45 Participants Total of all reporting groups
Age, Continuous	56 years n=9 Participants	60.5 years n=36 Participants	57 years n=45 Participants
Sex: Female, Male Female	6 Participants n=9 Participants	16 Participants n=36 Participants	22 Participants n=45 Participants
Sex: Female, Male Male	3 Participants n=9 Participants	20 Participants n=36 Participants	23 Participants n=45 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Site of Primary Tumour Pancreas	3 Participants n=9 Participants	12 Participants n=36 Participants	15 Participants n=45 Participants
Site of Primary Tumour Small Bowel	3 Participants n=9 Participants	17 Participants n=36 Participants	20 Participants n=45 Participants
Site of Primary Tumour Lung	3 Participants n=9 Participants	0 Participants n=36 Participants	3 Participants n=45 Participants
Site of Primary Tumour Other	0 Participants n=9 Participants	7 Participants n=36 Participants	7 Participants n=45 Participants
Tumour Grade - Histological Confirmation Grade 1	2 Participants n=9 Participants	13 Participants n=36 Participants	15 Participants n=45 Participants
Tumour Grade - Histological Confirmation Grade 2	7 Participants n=9 Participants	14 Participants n=36 Participants	21 Participants n=45 Participants
Tumour Grade - Histological Confirmation Unknown	0 Participants n=9 Participants	9 Participants n=36 Participants	9 Participants n=45 Participants

PRIMARY outcome

Timeframe: Baseline (on day of scan over 4 hours)

Population: The number of participants analysed differ within certain rows (breasts, ovaries, uterus and testes due to the anatomical differences between the participant groups.

Outcome measures

PRIMARY outcome

Timeframe: Baseline (on the day of the scan over 4 hours)

Population: Effective dose (ED) of \[18F\]-FET-βAG-TOCA in patients with histologically confirmed NETs.

Effective dose is an estimate of the overall risk of potential harm from exposure to ionising radiation. ED takes into account, the absorbed dose to all organs of the body, the relative harm level of the radiation and the sensitivities of each organ to radiation. ED may help in understanding the risk of potential long-term health effects from radiation exposure, such as the risk of developing cancer later in life. The unit of measure for ED is millisievert per megabecquerel (mSv/MBq), which refers to the effective dose (amount of radiation absorbed by the body) per unit of activity administered.

Outcome measures

Outcome measures
Measure	Part A: [18F]-FET-βAG-TOCA-PET/CT Performed in Male Patients With Histologically-confirmed NET. n=9 Participants Mean residence time (MBq.h/MBq) of \[18F\]-FET-βAG-TOCA within the organs of the male participants enrolled into Part A of the FETONET study. Patients with histologically confirmed neuroendocrine tumours (NET) enrolled into Part A of the FETONET study underwent whole-body dynamic \[18F\]-FET-βAG-TOCA PET/CT imaging at multiple time points over a 4-hour period, with sampling of venous bloods for radioactivity and radioactive metabolite quantification. The maximum dose of \[18F\]-FET-βAG-TOCA injected was 165MBq. Imaging Protocol for patients in Part A of the FETONET study: -2 minutes - Low dose attenuation CT. 0 minutes - Injection of \[18F\]-FET-βAG-TOCA (maximum of 165MBq) 0-242 - Dynamic whole body \[18F\]-FET-βAG-TOCA PET-CT (6 sweeps of the body). Following the fourth sweep, the patient had a 20 minutes break. The patient returned to the PET-CT scanner and had a second low-dose attenuation CT scan before completing PET/CT sweeps 5 \& 6. Total effective dose: 12 mSv In Part A of the FETONET study, two low-dose attenuation CT scans were performed per patient. Whereas, only one low-dose attenuation CT scan was performed per patient in Part A. The total effective dose per patient was therefore higher in Part A.	Part A: [18F]-FET-βAG-TOCA-PET/CT Performed in Female Patients With Histologically-confirmed NET. Mean residence time (MBq.h/MBq) of \[18F\]-FET-βAG-TOCA within the organs of the female participants enrolled into Part A of the FETONET study. Patients with histologically confirmed neuroendocrine tumours (NET) enrolled into Part A of the FETONET study underwent whole-body dynamic \[18F\]-FET-βAG-TOCA PET/CT imaging at multiple time points over a 4-hour period, with sampling of venous bloods for radioactivity and radioactive metabolite quantification. The maximum dose of \[18F\]-FET-βAG-TOCA injected was 165MBq. Imaging Protocol for patients in Part A of the FETONET study: -2 minutes - Low dose attenuation CT. 0 minutes - Injection of \[18F\]-FET-βAG-TOCA (maximum of 165MBq) 0-242 - Dynamic whole body \[18F\]-FET-βAG-TOCA PET-CT (6 sweeps of the body). Following the fourth sweep, the patient had a 20 minutes break. The patient returned to the PET-CT scanner and had a second low-dose attenuation CT scan before completing PET/CT sweeps 5 \& 6. Total effective dose: 12 mSv In Part A of the FETONET study, two low-dose attenuation CT scans were performed per patient. Whereas, only one low-dose attenuation CT scan was performed per patient in Part A. The total effective dose per patient was therefore higher in Part A.
To Calculate the Effective Dose (ED) of [18F]-FET-βAG-TOCA	0.029 Effective Dose (mSv/MBq) Standard Deviation 0.004	—

PRIMARY outcome

Timeframe: Baseline (on the scan day over 4 hours)

Population: The FETONET study was designed to have 3 parts. Part C comprised a prospective non-inferiority study, combining the \[18F\]FET-βAG-TOCA PET/CT data (collected at the optimal time point) for participants enrolled into Part A and Part B and compared this to standard of care \[68Ga\]Ga-DOTA-peptide PET/CT imaging. This trial design was a prospective decision for the purposes of efficiency. A total of 285 lesions were detected within the 45 patients analysed using this imaging modality.

Standardised uptake value (SUV) is a semiquantitative measurement of radiotracer uptake in tissue. It is a ratio that compares the activity concentration in a specific region of interest to the activity concentration in the whole body. SUVmax is the highest value of the SUV measured within a region of interest.

Outcome measures

Outcome measures
Measure	Part A: [18F]-FET-βAG-TOCA-PET/CT Performed in Male Patients With Histologically-confirmed NET. n=285 Lesions Mean residence time (MBq.h/MBq) of \[18F\]-FET-βAG-TOCA within the organs of the male participants enrolled into Part A of the FETONET study. Patients with histologically confirmed neuroendocrine tumours (NET) enrolled into Part A of the FETONET study underwent whole-body dynamic \[18F\]-FET-βAG-TOCA PET/CT imaging at multiple time points over a 4-hour period, with sampling of venous bloods for radioactivity and radioactive metabolite quantification. The maximum dose of \[18F\]-FET-βAG-TOCA injected was 165MBq. Imaging Protocol for patients in Part A of the FETONET study: -2 minutes - Low dose attenuation CT. 0 minutes - Injection of \[18F\]-FET-βAG-TOCA (maximum of 165MBq) 0-242 - Dynamic whole body \[18F\]-FET-βAG-TOCA PET-CT (6 sweeps of the body). Following the fourth sweep, the patient had a 20 minutes break. The patient returned to the PET-CT scanner and had a second low-dose attenuation CT scan before completing PET/CT sweeps 5 \& 6. Total effective dose: 12 mSv In Part A of the FETONET study, two low-dose attenuation CT scans were performed per patient. Whereas, only one low-dose attenuation CT scan was performed per patient in Part A. The total effective dose per patient was therefore higher in Part A.	Part A: [18F]-FET-βAG-TOCA-PET/CT Performed in Female Patients With Histologically-confirmed NET. Mean residence time (MBq.h/MBq) of \[18F\]-FET-βAG-TOCA within the organs of the female participants enrolled into Part A of the FETONET study. Patients with histologically confirmed neuroendocrine tumours (NET) enrolled into Part A of the FETONET study underwent whole-body dynamic \[18F\]-FET-βAG-TOCA PET/CT imaging at multiple time points over a 4-hour period, with sampling of venous bloods for radioactivity and radioactive metabolite quantification. The maximum dose of \[18F\]-FET-βAG-TOCA injected was 165MBq. Imaging Protocol for patients in Part A of the FETONET study: -2 minutes - Low dose attenuation CT. 0 minutes - Injection of \[18F\]-FET-βAG-TOCA (maximum of 165MBq) 0-242 - Dynamic whole body \[18F\]-FET-βAG-TOCA PET-CT (6 sweeps of the body). Following the fourth sweep, the patient had a 20 minutes break. The patient returned to the PET-CT scanner and had a second low-dose attenuation CT scan before completing PET/CT sweeps 5 \& 6. Total effective dose: 12 mSv In Part A of the FETONET study, two low-dose attenuation CT scans were performed per patient. Whereas, only one low-dose attenuation CT scan was performed per patient in Part A. The total effective dose per patient was therefore higher in Part A.
To Assess Tumoural Uptake of [18F]-FET-βAG-TOCA Lung	10.4 SUVmax Interval 5.3 to 42.1	—
To Assess Tumoural Uptake of [18F]-FET-βAG-TOCA Head & Neck	12.4 SUVmax Interval 10.4 to 27.7	—
To Assess Tumoural Uptake of [18F]-FET-βAG-TOCA Liver	19.6 SUVmax Interval 7.2 to 132.4	—
To Assess Tumoural Uptake of [18F]-FET-βAG-TOCA Bone	9.7 SUVmax Interval 2.2 to 37.0	—
To Assess Tumoural Uptake of [18F]-FET-βAG-TOCA Pancreas	24.5 SUVmax Interval 4.2 to 85.8	—
To Assess Tumoural Uptake of [18F]-FET-βAG-TOCA Abdomen/Pelvis	18.8 SUVmax Interval 2.7 to 152.3	—
To Assess Tumoural Uptake of [18F]-FET-βAG-TOCA Lymph Nodes	18.0 SUVmax Interval 3.4 to 102.4	—

SECONDARY outcome

Timeframe: [68Ga]Ga-DOTA-peptide PET/CT imaging performed within 6 months of the [18F]-FET-βAG-TOCA PET/CT scan.

Population: The FETONET study was designed to have 3 parts. Part C comprised a prospective non-inferiority study. \[18F\]FET-βAG-TOCA PET/CT data collected for patients enrolled into Parts A and B of the FETONET study were combined and compared to \[68Ga\]Ga-DOTA-peptide PET/CT (standard of care) imaging. This trial design was a prospective decision for the purposes of efficiency. A total of 285 lesions (45 patients) were detected using \[18F\]-FET-βAG-TOCA \& \[68Ga\]Ga-DOTA-peptide PET/CT imaging.

To determine the clinical utility of \[18F\]-FET-βAG-TOCA-PET/CT compared with standard of care \[68Ga\]Ga-DOTA-peptide imaging. Standardised uptake value (SUV) is a semiquantitative measurement of radiotracer uptake in tissue. It is a ratio that compares the activity concentration in a specific region of interest to the activity concentration in the whole body. SUVmax is the highest value of the SUV measured within a region of interest. The median SUVmax of \[18F\]-FET-βAG-TOCA and \[68Ga\]-DOTA-peptide per anatomic region were calculated to determine diagnostic efficacy. Diagnostic efficacy is the ability of a test to correctly identify a disease or condition when it's present and correctly identify the absence of a disease when it's not present.

Outcome measures

Outcome measures
Measure	Part A: [18F]-FET-βAG-TOCA-PET/CT Performed in Male Patients With Histologically-confirmed NET. n=285 Lesions Mean residence time (MBq.h/MBq) of \[18F\]-FET-βAG-TOCA within the organs of the male participants enrolled into Part A of the FETONET study. Patients with histologically confirmed neuroendocrine tumours (NET) enrolled into Part A of the FETONET study underwent whole-body dynamic \[18F\]-FET-βAG-TOCA PET/CT imaging at multiple time points over a 4-hour period, with sampling of venous bloods for radioactivity and radioactive metabolite quantification. The maximum dose of \[18F\]-FET-βAG-TOCA injected was 165MBq. Imaging Protocol for patients in Part A of the FETONET study: -2 minutes - Low dose attenuation CT. 0 minutes - Injection of \[18F\]-FET-βAG-TOCA (maximum of 165MBq) 0-242 - Dynamic whole body \[18F\]-FET-βAG-TOCA PET-CT (6 sweeps of the body). Following the fourth sweep, the patient had a 20 minutes break. The patient returned to the PET-CT scanner and had a second low-dose attenuation CT scan before completing PET/CT sweeps 5 \& 6. Total effective dose: 12 mSv In Part A of the FETONET study, two low-dose attenuation CT scans were performed per patient. Whereas, only one low-dose attenuation CT scan was performed per patient in Part A. The total effective dose per patient was therefore higher in Part A.	Part A: [18F]-FET-βAG-TOCA-PET/CT Performed in Female Patients With Histologically-confirmed NET. n=285 Lesions Mean residence time (MBq.h/MBq) of \[18F\]-FET-βAG-TOCA within the organs of the female participants enrolled into Part A of the FETONET study. Patients with histologically confirmed neuroendocrine tumours (NET) enrolled into Part A of the FETONET study underwent whole-body dynamic \[18F\]-FET-βAG-TOCA PET/CT imaging at multiple time points over a 4-hour period, with sampling of venous bloods for radioactivity and radioactive metabolite quantification. The maximum dose of \[18F\]-FET-βAG-TOCA injected was 165MBq. Imaging Protocol for patients in Part A of the FETONET study: -2 minutes - Low dose attenuation CT. 0 minutes - Injection of \[18F\]-FET-βAG-TOCA (maximum of 165MBq) 0-242 - Dynamic whole body \[18F\]-FET-βAG-TOCA PET-CT (6 sweeps of the body). Following the fourth sweep, the patient had a 20 minutes break. The patient returned to the PET-CT scanner and had a second low-dose attenuation CT scan before completing PET/CT sweeps 5 \& 6. Total effective dose: 12 mSv In Part A of the FETONET study, two low-dose attenuation CT scans were performed per patient. Whereas, only one low-dose attenuation CT scan was performed per patient in Part A. The total effective dose per patient was therefore higher in Part A.
To Compare the Diagnostic Efficacy of [18F]-FET-βAG-TOCA PET/CT With Standard of Care Somatostatin Receptor Imaging in Patients With a Histological Diagnosis of NET. Liver	19.6 Median Tumour Uptake (SUVmax) Interval 7.2 to 132.4	20.6 Median Tumour Uptake (SUVmax) Interval 6.7 to 95.1
To Compare the Diagnostic Efficacy of [18F]-FET-βAG-TOCA PET/CT With Standard of Care Somatostatin Receptor Imaging in Patients With a Histological Diagnosis of NET. Head & Neck	12.4 Median Tumour Uptake (SUVmax) Interval 10.4 to 27.7	6.9 Median Tumour Uptake (SUVmax) Interval 6.4 to 23.4
To Compare the Diagnostic Efficacy of [18F]-FET-βAG-TOCA PET/CT With Standard of Care Somatostatin Receptor Imaging in Patients With a Histological Diagnosis of NET. Bone	9.7 Median Tumour Uptake (SUVmax) Interval 2.2 to 37.0	7.2 Median Tumour Uptake (SUVmax) Interval 1.9 to 38.8
To Compare the Diagnostic Efficacy of [18F]-FET-βAG-TOCA PET/CT With Standard of Care Somatostatin Receptor Imaging in Patients With a Histological Diagnosis of NET. Pancreas	24.5 Median Tumour Uptake (SUVmax) Interval 4.2 to 85.8	21.9 Median Tumour Uptake (SUVmax) Interval 6.4 to 88.4
To Compare the Diagnostic Efficacy of [18F]-FET-βAG-TOCA PET/CT With Standard of Care Somatostatin Receptor Imaging in Patients With a Histological Diagnosis of NET. Abdomen/Pelvis	18.8 Median Tumour Uptake (SUVmax) Interval 2.7 to 152.3	21.2 Median Tumour Uptake (SUVmax) Interval 4.1 to 110.3
To Compare the Diagnostic Efficacy of [18F]-FET-βAG-TOCA PET/CT With Standard of Care Somatostatin Receptor Imaging in Patients With a Histological Diagnosis of NET. Lymph Nodes	18.0 Median Tumour Uptake (SUVmax) Interval 3.4 to 102.4	17.0 Median Tumour Uptake (SUVmax) Interval 3.1 to 122.9
To Compare the Diagnostic Efficacy of [18F]-FET-βAG-TOCA PET/CT With Standard of Care Somatostatin Receptor Imaging in Patients With a Histological Diagnosis of NET. Lung	10.4 Median Tumour Uptake (SUVmax) Interval 5.3 to 42.1	9.4 Median Tumour Uptake (SUVmax) Interval 2.2 to 38.0

SECONDARY outcome

Timeframe: [68Ga]Ga-DOTA-peptide PET/CT imaging assessed within 6 months of the [18F]-FET-βAG-TOCA PET/CT scan.

Population: The FETONET study was designed to have 3 parts. Part C comprised a prospective non-inferiority study. \[18F\]FET-βAG-TOCA PET/CT data for the patients enrolled into Parts A and B of the FETONET study (45 patients) were compared to standard of care \[68Ga\]Ga-DOTA-peptide PET/CT imaging. This trial design was a prospective decision for the purposes of efficiency. All PET/CT scans analysed within Part C were reviewed by independent imaging experts to determine an inter-reader lesion detection rate.

The \[18F\]FET-βAG-TOCA and \[68Ga\]Ga-DOTA-peptide PET/CT scans were reviewed by independent imaging experts to obtain an objective inter-reader lesion detection rate. To avoid recall bias, the \[18F\]FET-βAG-TOCA and \[68Ga\]Ga-DOTA-peptide PET/CT scans for each subject were reviewed at less 4 weeks apart in random order Percentage of agreement, also known as percent agreement, is a simple method to measure inter-rater reliability (IRR), calculating the proportion of times raters agree without considering chance. It's calculated by dividing the number of agreements by the total number of ratings and multiplying by 100

Outcome measures

Outcome measures
Measure	Part A: [18F]-FET-βAG-TOCA-PET/CT Performed in Male Patients With Histologically-confirmed NET. n=45 Participants Mean residence time (MBq.h/MBq) of \[18F\]-FET-βAG-TOCA within the organs of the male participants enrolled into Part A of the FETONET study. Patients with histologically confirmed neuroendocrine tumours (NET) enrolled into Part A of the FETONET study underwent whole-body dynamic \[18F\]-FET-βAG-TOCA PET/CT imaging at multiple time points over a 4-hour period, with sampling of venous bloods for radioactivity and radioactive metabolite quantification. The maximum dose of \[18F\]-FET-βAG-TOCA injected was 165MBq. Imaging Protocol for patients in Part A of the FETONET study: -2 minutes - Low dose attenuation CT. 0 minutes - Injection of \[18F\]-FET-βAG-TOCA (maximum of 165MBq) 0-242 - Dynamic whole body \[18F\]-FET-βAG-TOCA PET-CT (6 sweeps of the body). Following the fourth sweep, the patient had a 20 minutes break. The patient returned to the PET-CT scanner and had a second low-dose attenuation CT scan before completing PET/CT sweeps 5 \& 6. Total effective dose: 12 mSv In Part A of the FETONET study, two low-dose attenuation CT scans were performed per patient. Whereas, only one low-dose attenuation CT scan was performed per patient in Part A. The total effective dose per patient was therefore higher in Part A.	Part A: [18F]-FET-βAG-TOCA-PET/CT Performed in Female Patients With Histologically-confirmed NET. n=45 Participants Mean residence time (MBq.h/MBq) of \[18F\]-FET-βAG-TOCA within the organs of the female participants enrolled into Part A of the FETONET study. Patients with histologically confirmed neuroendocrine tumours (NET) enrolled into Part A of the FETONET study underwent whole-body dynamic \[18F\]-FET-βAG-TOCA PET/CT imaging at multiple time points over a 4-hour period, with sampling of venous bloods for radioactivity and radioactive metabolite quantification. The maximum dose of \[18F\]-FET-βAG-TOCA injected was 165MBq. Imaging Protocol for patients in Part A of the FETONET study: -2 minutes - Low dose attenuation CT. 0 minutes - Injection of \[18F\]-FET-βAG-TOCA (maximum of 165MBq) 0-242 - Dynamic whole body \[18F\]-FET-βAG-TOCA PET-CT (6 sweeps of the body). Following the fourth sweep, the patient had a 20 minutes break. The patient returned to the PET-CT scanner and had a second low-dose attenuation CT scan before completing PET/CT sweeps 5 \& 6. Total effective dose: 12 mSv In Part A of the FETONET study, two low-dose attenuation CT scans were performed per patient. Whereas, only one low-dose attenuation CT scan was performed per patient in Part A. The total effective dose per patient was therefore higher in Part A.
Comparison of [18F]-FET-βAG-TOCA PET/CT Scan and Central Review (Nuclear Medicine and Radiology Physician Experts) of All Imaging Received. Head & Neck	97.4 Percentage of Agreement	97.8 Percentage of Agreement
Comparison of [18F]-FET-βAG-TOCA PET/CT Scan and Central Review (Nuclear Medicine and Radiology Physician Experts) of All Imaging Received. Lung	97.8 Percentage of Agreement	98.9 Percentage of Agreement
Comparison of [18F]-FET-βAG-TOCA PET/CT Scan and Central Review (Nuclear Medicine and Radiology Physician Experts) of All Imaging Received. Liver	94.4 Percentage of Agreement	98.5 Percentage of Agreement
Comparison of [18F]-FET-βAG-TOCA PET/CT Scan and Central Review (Nuclear Medicine and Radiology Physician Experts) of All Imaging Received. Pancreas	89.3 Percentage of Agreement	91.5 Percentage of Agreement
Comparison of [18F]-FET-βAG-TOCA PET/CT Scan and Central Review (Nuclear Medicine and Radiology Physician Experts) of All Imaging Received. Abdomen/Pelvis	88.5 Percentage of Agreement	95.2 Percentage of Agreement
Comparison of [18F]-FET-βAG-TOCA PET/CT Scan and Central Review (Nuclear Medicine and Radiology Physician Experts) of All Imaging Received. Bone	98.5 Percentage of Agreement	100 Percentage of Agreement
Comparison of [18F]-FET-βAG-TOCA PET/CT Scan and Central Review (Nuclear Medicine and Radiology Physician Experts) of All Imaging Received. Lymph Node	97.4 Percentage of Agreement	96.3 Percentage of Agreement

Adverse Events

Part A

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part B

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Part A n=9 participants at risk Patients with histologically-confirmed neuroendocrine tumours (NET) enrolled into Part A of the FETONET study underwent whole-body dynamic \[18F\]-FET-βAG-TOCA PET/CT imaging at multiple time points over a 4 hour period, with sampling of venous bloods for radioactivity and radioactive metabolite quantification.	Part B n=47 participants at risk Patients with histologically confirmed neuroendocrine tumours (NET) underwent PET/CT imaging with both \[18F\]-FET-βAG-TOCA and \[68Ga\]Ga-peptide. The two PET/CT scans were performed within a 6-month time period. Whole-body static \[18F\]-FET-βAG-TOCA PET-CT imaging was conducted 50 minutes post-injection.
Skin and subcutaneous tissue disorders Erythema	11.1% 1/9 • Number of events 1 • Safety data will be collected at baseline and after the administration of the radiotracer for up to 24 hours.	0.00% 0/47 • Safety data will be collected at baseline and after the administration of the radiotracer for up to 24 hours.
Blood and lymphatic system disorders Hypertension	11.1% 1/9 • Number of events 1 • Safety data will be collected at baseline and after the administration of the radiotracer for up to 24 hours.	0.00% 0/47 • Safety data will be collected at baseline and after the administration of the radiotracer for up to 24 hours.
General disorders Altered Taste Sensation	0.00% 0/9 • Safety data will be collected at baseline and after the administration of the radiotracer for up to 24 hours.	2.1% 1/47 • Number of events 1 • Safety data will be collected at baseline and after the administration of the radiotracer for up to 24 hours.

Additional Information

Professor Rohini Sharma

Imperial College London

Phone: 0203 313 3720

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Part A: [18F]-FET-βAG-TOCA-PET/CT Performed in Male Patients With Histologically-confirmed NET. n=3 Participants Mean residence time (MBq.h/MBq) of \[18F\]-FET-βAG-TOCA within the organs of the male participants enrolled into Part A of the FETONET study. Patients with histologically confirmed neuroendocrine tumours (NET) enrolled into Part A of the FETONET study underwent whole-body dynamic \[18F\]-FET-βAG-TOCA PET/CT imaging at multiple time points over a 4-hour period, with sampling of venous bloods for radioactivity and radioactive metabolite quantification. The maximum dose of \[18F\]-FET-βAG-TOCA injected was 165MBq. Imaging Protocol for patients in Part A of the FETONET study: -2 minutes - Low dose attenuation CT. 0 minutes - Injection of \[18F\]-FET-βAG-TOCA (maximum of 165MBq) 0-242 - Dynamic whole body \[18F\]-FET-βAG-TOCA PET-CT (6 sweeps of the body). Following the fourth sweep, the patient had a 20 minutes break. The patient returned to the PET-CT scanner and had a second low-dose attenuation CT scan before completing PET/CT sweeps 5 \& 6. Total effective dose: 12 mSv In Part A of the FETONET study, two low-dose attenuation CT scans were performed per patient. Whereas, only one low-dose attenuation CT scan was performed per patient in Part A. The total effective dose per patient was therefore higher in Part A.	Part A: [18F]-FET-βAG-TOCA-PET/CT Performed in Female Patients With Histologically-confirmed NET. n=6 Participants Mean residence time (MBq.h/MBq) of \[18F\]-FET-βAG-TOCA within the organs of the female participants enrolled into Part A of the FETONET study. Patients with histologically confirmed neuroendocrine tumours (NET) enrolled into Part A of the FETONET study underwent whole-body dynamic \[18F\]-FET-βAG-TOCA PET/CT imaging at multiple time points over a 4-hour period, with sampling of venous bloods for radioactivity and radioactive metabolite quantification. The maximum dose of \[18F\]-FET-βAG-TOCA injected was 165MBq. Imaging Protocol for patients in Part A of the FETONET study: -2 minutes - Low dose attenuation CT. 0 minutes - Injection of \[18F\]-FET-βAG-TOCA (maximum of 165MBq) 0-242 - Dynamic whole body \[18F\]-FET-βAG-TOCA PET-CT (6 sweeps of the body). Following the fourth sweep, the patient had a 20 minutes break. The patient returned to the PET-CT scanner and had a second low-dose attenuation CT scan before completing PET/CT sweeps 5 \& 6. Total effective dose: 12 mSv In Part A of the FETONET study, two low-dose attenuation CT scans were performed per patient. Whereas, only one low-dose attenuation CT scan was performed per patient in Part A. The total effective dose per patient was therefore higher in Part A.
To Determine the Biodistribution of [18F] Following Single I.V Administration of [18F]-FET-βAG-TOCA Injection in Patients With a Histological Diagnosis of NET. Adrenals	0.002 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.0002	0.003 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.0008
To Determine the Biodistribution of [18F] Following Single I.V Administration of [18F]-FET-βAG-TOCA Injection in Patients With a Histological Diagnosis of NET. Brain	0.006 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.001	0.007 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.001
To Determine the Biodistribution of [18F] Following Single I.V Administration of [18F]-FET-βAG-TOCA Injection in Patients With a Histological Diagnosis of NET. Breasts	—	0.004 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.001
To Determine the Biodistribution of [18F] Following Single I.V Administration of [18F]-FET-βAG-TOCA Injection in Patients With a Histological Diagnosis of NET. Cortical Bone	0.049 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.002	0.040 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.016
To Determine the Biodistribution of [18F] Following Single I.V Administration of [18F]-FET-βAG-TOCA Injection in Patients With a Histological Diagnosis of NET. Gallbladder	0.110 Mean Residence Time (MBq-h/MBq)	0.072 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.019
To Determine the Biodistribution of [18F] Following Single I.V Administration of [18F]-FET-βAG-TOCA Injection in Patients With a Histological Diagnosis of NET. Heart Contents	0.029 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.014	0.019 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.005
To Determine the Biodistribution of [18F] Following Single I.V Administration of [18F]-FET-βAG-TOCA Injection in Patients With a Histological Diagnosis of NET. Heart Wall	0.020 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.010	0.013 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.004
To Determine the Biodistribution of [18F] Following Single I.V Administration of [18F]-FET-βAG-TOCA Injection in Patients With a Histological Diagnosis of NET. Kidneys	0.088 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.007	0.089 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.026
To Determine the Biodistribution of [18F] Following Single I.V Administration of [18F]-FET-βAG-TOCA Injection in Patients With a Histological Diagnosis of NET. Liver	0.478 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.073	0.089 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.084
To Determine the Biodistribution of [18F] Following Single I.V Administration of [18F]-FET-βAG-TOCA Injection in Patients With a Histological Diagnosis of NET. Lungs	0.063 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.009	0.067 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.025
To Determine the Biodistribution of [18F] Following Single I.V Administration of [18F]-FET-βAG-TOCA Injection in Patients With a Histological Diagnosis of NET. Lower Large Intestine	0.012 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.002	0.019 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.011
To Determine the Biodistribution of [18F] Following Single I.V Administration of [18F]-FET-βAG-TOCA Injection in Patients With a Histological Diagnosis of NET. Muscle	0.709 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.154	0.600 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.154
To Determine the Biodistribution of [18F] Following Single I.V Administration of [18F]-FET-βAG-TOCA Injection in Patients With a Histological Diagnosis of NET. Ovaries	—	0.0005 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.00004
To Determine the Biodistribution of [18F] Following Single I.V Administration of [18F]-FET-βAG-TOCA Injection in Patients With a Histological Diagnosis of NET. Pancreas	0.017 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.006	0.010 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.0035
To Determine the Biodistribution of [18F] Following Single I.V Administration of [18F]-FET-βAG-TOCA Injection in Patients With a Histological Diagnosis of NET. Red Marrow	0.028 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.004	0.050 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.032
To Determine the Biodistribution of [18F] Following Single I.V Administration of [18F]-FET-βAG-TOCA Injection in Patients With a Histological Diagnosis of NET. Small Intestine	0.094 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.065	0.121 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.055
To Determine the Biodistribution of [18F] Following Single I.V Administration of [18F]-FET-βAG-TOCA Injection in Patients With a Histological Diagnosis of NET. Stomach	0.005 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.029	0.066 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.222
To Determine the Biodistribution of [18F] Following Single I.V Administration of [18F]-FET-βAG-TOCA Injection in Patients With a Histological Diagnosis of NET. Spleen	0.122 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.019	0.097 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.026
To Determine the Biodistribution of [18F] Following Single I.V Administration of [18F]-FET-βAG-TOCA Injection in Patients With a Histological Diagnosis of NET. Testes	0.001 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.0002	—
To Determine the Biodistribution of [18F] Following Single I.V Administration of [18F]-FET-βAG-TOCA Injection in Patients With a Histological Diagnosis of NET. Thyroid	0.001 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.0003	0.0008 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.0003
To Determine the Biodistribution of [18F] Following Single I.V Administration of [18F]-FET-βAG-TOCA Injection in Patients With a Histological Diagnosis of NET. Upper Large Intestine	0.026 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.004	0.028 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.014
To Determine the Biodistribution of [18F] Following Single I.V Administration of [18F]-FET-βAG-TOCA Injection in Patients With a Histological Diagnosis of NET. Urinary Bladder	0.075 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.019	0.101 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.028
To Determine the Biodistribution of [18F] Following Single I.V Administration of [18F]-FET-βAG-TOCA Injection in Patients With a Histological Diagnosis of NET. Uterus	—	0.006 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.001
To Determine the Biodistribution of [18F] Following Single I.V Administration of [18F]-FET-βAG-TOCA Injection in Patients With a Histological Diagnosis of NET. Remainder	0.523 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.250	0.628 Mean Residence Time (MBq-h/MBq) Standard Deviation 0.025