Trial Outcomes & Findings for 18F-FSPG PET/CT for Cancer Patients on Therapy (NCT NCT02599194)

Last Updated: 2019-01-03

Results Overview

Standard Uptake Values (SUVs) for the radiotracers labels 18F-FSPG and 18F-FDG were assessed in tumor tissues of study participants, before (baseline), and after therapeutic treatment. Time frame was specified by protocol as at baseline, and at the time of clinical assessments during individual patient regular medical care. The time of the post-treatment assessment was not otherwise explicitly defined but could be anytime within 2 years. The outcome is reported as the difference of means from baseline to post-treatment (a number without dispersion), for all lesions for which an SUVmax value was assessed. A negative result indicates less uptake of radiotracer suggesting a small volume of tumor.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

Baseline and up to 2 years

Results posted on

2019-01-03

Participant Flow

Participant milestones

Participant milestones
Measure	18F-FSPG and 18F-FDG Intragroup Comparision Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes. 18F-FSPG: Administered intravenously (IV) 18F-FDG: Administered intravenously (IV)
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

18F-FSPG PET/CT for Cancer Patients on Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	18F-FSPG and 18F-FDG Intragroup Comparision n=7 Participants Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes. 18F-FSPG: Administered intravenously (IV) 18F-FDG: Administered intravenously (IV)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age, Continuous	69.1 years STANDARD_DEVIATION 13.2 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and up to 2 years

Population: Locations (ie, of lesions) that did not produce an SUVmax value either before or after treatment are omitted from the mean. Note that an analysis "mean of differences" would have a dispersion, but an analysis for "difference of means" is simply the delta (a number) between 2 measures of central tendency (mean), and does not have a dispersion.

Outcome measures

Outcome measures
Measure	18F-FSPG and 18F-FDG Intragroup Comparision n=40 Lesion locations assessed Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes. 18F-FSPG: Administered intravenously (IV) 18F-FDG: Administered intravenously (IV)	Difference in Lesion Size as Detected by 18F-FDG Participants sequentially receive radioimaging agent 18F-FDG IV followed by PET/CT scan with 60 minutes. 18F-FDG: Administered intravenously (IV)
Change From Baseline in Standard Uptake Value Maximum (SUVmax) Post-treatment 18F-FSPG	-1.69 g/mL	—
Change From Baseline in Standard Uptake Value Maximum (SUVmax) Post-treatment 18F-FDG	-0.64 g/mL	—

SECONDARY outcome

Timeframe: Baseline to up to 2 years

Safety and tolerability of 18F-FSPG and 18F-FDG were assessed as treatment-related adverse events, and reported as the number of events related to each treatment, without dispersion.

Outcome measures

Outcome measures
Measure	18F-FSPG and 18F-FDG Intragroup Comparision n=7 Participants Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes. 18F-FSPG: Administered intravenously (IV) 18F-FDG: Administered intravenously (IV)	Difference in Lesion Size as Detected by 18F-FDG Participants sequentially receive radioimaging agent 18F-FDG IV followed by PET/CT scan with 60 minutes. 18F-FDG: Administered intravenously (IV)
Number of Treatment-Related Adverse Events 18F-FSPG	0 adverse events	—
Number of Treatment-Related Adverse Events 18F-FDG	0 adverse events	—

SECONDARY outcome

Timeframe: Baseline and up to 2 years

Population: * Lesion locations not detected both before and after treatment are reported as N/A for 2-D area (in the effect that an assessment could be made with the other radiolabel). * Lesions detected at either before or after treatment only are reported as the difference from zero.

Lesion size in centimeters (cm) were assessed in 2 dimensions from the computed tomography (CT) component of PET/CT and the area in cm2 calculated for lesion locations at baseline and after treatment. Time frame was specified by protocol as at baseline, and at the time of clinical assessments during individual patient regular medical care. The time of the post-treatment assessment was not otherwise explicitly defined but could be anytime within 2 years. The outcome is reported the difference in area in cm² for each lesion (a number without dispersion).

Outcome measures

Outcome measures
Measure	18F-FSPG and 18F-FDG Intragroup Comparision n=17 Lesion locations assessed Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes. 18F-FSPG: Administered intravenously (IV) 18F-FDG: Administered intravenously (IV)	Difference in Lesion Size as Detected by 18F-FDG n=26 Lesion locations assessed Participants sequentially receive radioimaging agent 18F-FDG IV followed by PET/CT scan with 60 minutes. 18F-FDG: Administered intravenously (IV)
Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs Adrenal / adrenal mass, left	NA cm2 Lesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.	11.3 cm2
Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs Adrenal / hepatic dome	NA cm2 Lesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.	-2.0 cm2
Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs Adrenal / liver metastatis	NA cm2 Lesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.	-1.3 cm2
Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs Adrenal / lung base metastatis, lower lobe right	NA cm2 Lesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.	1.4 cm2
Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs Adrenal / lung metastatis, left	NA cm2 Lesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.	-0.7 cm2
Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs Lung / infrascapular subcut	0.2 cm2	NA cm2 Lesion location was not detected by 18F-FDG both before and after treatment, and no difference can be reported for 2-D area.
Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs Lung / abdominal wall, upper quadrant right	7.6 cm2	6.9 cm2
Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs Lung / adajcent subcarinal lymph node	NA cm2 Lesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.	3.0 cm2
Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs Lung / aortopulmonary window lymph node	-1.1 cm2	-2.8 cm2
Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs Lung / hilar lymph node, left	NA cm2 Lesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.	-2.3 cm2
Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs Lung / infraspinatus mm, right	10.4 cm2	10.2 cm2
Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs Lung / lingula nodule	-1.7 cm2	-2.7 cm2
Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs Lung / mass, upper lobe left	-8.1 cm2	-6.4 cm2
Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs Lung / mass, lower lobe right	NA cm2 Lesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.	-14.5 cm2
Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs Lung / nodule 1, lower lobe right	NA cm2 Lesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.	-0.8 cm2
Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs Lung / nodule 2, upper lobe right	-1.7 cm2	-1.5 cm2
Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs Lung / nodule, upper lobe right	NA cm2 Lesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.	-0.4 cm2
Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs Lung / paraesophageal lymph node	0.9 cm2	NA cm2 Lesion location was not detected by 18F-FDG both before and after treatment, and no difference can be reported for 2-D area.
Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs Lung / post-basal, lower lobe right	NA cm2 Lesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.	-3.6 cm2
Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs Lung / subcarinal lymph node	1.4 cm2	11.4 cm2
Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs Renal / adrenal mass, right	3.1 cm2	7.1 cm2
Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs Renal / aortopulmonary window lymph node, left	1.1 cm2	-1.2 cm2
Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs Renal / gluteal subcutaneous nodule	0.2 cm2	0.2 cm2
Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs Renal / interlobar	2.4 cm2	NA cm2 Lesion location was not detected by 18F-FDG both before and after treatment, and no difference can be reported for 2-D area.
Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs Renal / kidney midpole, right	-1.2 cm2	-1.4 cm2
Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs Renal / omental nodule	-0.2 cm2	1.2 cm2
Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs Renal / paratracheal lymph node, right	0.6 cm2	-2.0 cm2
Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs Renal / parotid, right	NA cm2 Lesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.	-2.3 cm2
Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs Renal / retroperitoneal lymph node, left	1.6 cm2	2.2 cm2

Adverse Events

18F-FSPG and 18F-FDG Intragroup Comparision

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	18F-FSPG and 18F-FDG Intragroup Comparision n=7 participants at risk Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes. 18F-FSPG: Administered intravenously (IV) 18F-FDG: Administered intravenously (IV)
Metabolism and nutrition disorders Elevated blood ammonia	14.3% 1/7 • Number of events 1 • 30 days

Additional Information

Andrei H. Iagaru

Stanford University

Phone: (650) 725-4711

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place