Trial Outcomes & Findings for Measuring Fatty Acid Oxidation in Cerebral Metastases Using [18F]FPIA (NCT NCT04807582)

Last Updated: 2025-04-02

Results Overview

Standardised uptake value (SUV) at 60 minutes post-injection of \[18F\]FPIA assessed using PET/MRI. SUV is a semiquantitative measurement of radiotracer uptake in tissue. It is a ratio of tissue radioactivity concentration at a point in time within a specific region of interest and the injected dose of radioactivity per kilogram of the patient's body weight. SUVmax is the highest SUV value within a region of interest.

Recruitment status

COMPLETED

Target enrollment

22 participants

Primary outcome timeframe

On the scan day up to 60 minutes

Results posted on

2025-04-02

Participant Flow

The study was open to recruitment from Intervention: Administration of \[18F\]FPIA followed by the performance of a positron emission tomography-multiparametric magnetic resonance imaging (PET-mMRI) performed at Invicro, Centre for Imaging Sciences, Burlington Danes, Imperial College London (Hammersmith Hospital Campus), Du Cane Road, London, W12 0NN. The aim of the study was to quantify the degree of early step fatty acid oxidation in cerebral metastases as imaged by \[18F\]FPIA PET-mMRI.

Participant milestones

Participant milestones
Measure	Patients With Radiological Evidence of IMD That Are Treatment Naive. Participants with radiological evidence of intracranial metastatic disease (IMD) on standard of care contrast-enhanced magnetic resonance imaging (CE-MRI) that were treatment-naive at the time of enrolment/\[18F\]FPIA PET-mpMRI scanning. Participants enrolled into the study had \[18F\]FPIA positron emission tomography-multiparametric magnetic resonance imaging (PET-mMRI) scan(s) performed at the Invicro, Centre for Imaging Sciences. A single intravenous dose of \[18F\]FPIA (maximum, 370MBq) was administered to the participant followed by a whole brain dynamic PET-MRI scan over 66 minutes.	Patients With Radiological Evidence of IMD That Had Completed Stereotactic Radiosurgery. Participants with radiological evidence of intracranial metastatic disease (IMD) on standard of care contrast-enhanced magnetic resonance imaging (CE-MRI) that had completed stereotactic radiosurgery (SRS) (+/- combination therapy) within 4-8 weeks of \[18F\]FPIA PET-mMRI. Participants enrolled into the study had \[18F\]FPIA positron emission tomography-multiparametric magnetic resonance imaging (PET-mMRI) scans performed at the Invicro, Centre for Imaging Sciences. A single intravenous dose of \[18F\]FPIA (maximum, 370MBq) was administered to the participant followed by a whole brain dynamic PET-MRI scan over 66 minutes.
Overall Study STARTED	12	10
Overall Study COMPLETED	12	10
Overall Study NOT COMPLETED	0	0

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	Patients With Radiological Evidence of IMD That Are Treatment Naive. n=12 Participants Participants with radiological evidence of intracranial metastatic disease (IMD) on standard of care contrast-enhanced magnetic resonance imaging (CE-MRI) that were treatment-naive for their IMD at the time of enrolment/\[18F\]FPIA positron emission tomography-multiparametric magnetic resonance imaging (PET-mpMRI). Participants enrolled into the study had an \[18F\]FPIA PET-mpMRI scan performed at the Invicro, Centre for Imaging Sciences. A single intravenous dose of \[18F\]FPIA (maximum, 370MBq) was administered to the participant followed by a whole brain dynamic PET-MRI scan over 66 minutes.	Patients With Radiological Evidence of IMD That Had Completed Stereotactic Radiosurgery. n=10 Participants Participants with radiological evidence of intracranial metastatic disease (IMD) on standard of care contrast-enhanced magnetic resonance imaging (CE-MRI) that had completed stereotactic radiosurgery (SRS) (+/- combination therapy) within 4-8 weeks of \[18F\]FPIA positron emission tomography multiparametric magnetic resonance imaging (PET-mpMRI). Participants enrolled into the study had an \[18F\]FPIA PET-mpMRI scans performed at the Invicro, Centre for Imaging Sciences. A single intravenous dose of \[18F\]FPIA (maximum, 370 MBq) was administered to the participant followed by a whole brain dynamic PET-MRI scan over 66 minutes.	Total n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=12 Participants	0 Participants n=10 Participants	0 Participants n=22 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=12 Participants	6 Participants n=10 Participants	10 Participants n=22 Participants
Age, Categorical >=65 years	8 Participants n=12 Participants	4 Participants n=10 Participants	12 Participants n=22 Participants
Age, Continuous	67.5 years n=12 Participants	62.5 years n=10 Participants	64 years n=22 Participants
Sex: Female, Male Female	3 Participants n=12 Participants	7 Participants n=10 Participants	10 Participants n=22 Participants
Sex: Female, Male Male	9 Participants n=12 Participants	3 Participants n=10 Participants	12 Participants n=22 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Extracranial tumour of origin Breast	2 Participants n=12 Participants	3 Participants n=10 Participants	5 Participants n=22 Participants
Extracranial tumour of origin Lung	8 Participants n=12 Participants	6 Participants n=10 Participants	14 Participants n=22 Participants
Extracranial tumour of origin Melanoma	1 Participants n=12 Participants	1 Participants n=10 Participants	2 Participants n=22 Participants
Extracranial tumour of origin Colorectal	1 Participants n=12 Participants	0 Participants n=10 Participants	1 Participants n=22 Participants

PRIMARY outcome

Timeframe: On the scan day up to 60 minutes

Outcome measures

Outcome measures
Measure	[18F]FPIA PET-mMRI Scans Performed on Patients With Treatment-naive IMD on CE-MRI. n=17 Lesions Participants with radiological evidence of intracranial metastatic disease (IMD) on standard of care contrast-enhanced magnetic resonance imaging (CE-MRI) that were treatment-naive for their IMD at the time of enrolment/\[18F\]FPIA PET-mMRI scan. Participants enrolled into the treatment-naive cohort that went onto have stereotactic radiosurgery (SRS) could also provide written informed consent to be scanned within the 4-8 weeks post-SRS cohort. Participants enrolled into the study had either one or two \[18F\]FPIA positron emission tomography-multiparametric magnetic resonance imaging (PET-mMRI) scans performed at the Invicro, Centre for Imaging Sciences. A single intravenous dose of \[18F\]FPIA (maximum, 370MBq) was administered to the participant followed by a whole brain dynamic PET-MRI scan over 66 minutes.	[18F]FPIA PET-mMRI Scans Performed on Patients With IMD on CE-MRI That Had Undergone SRS Treatment. Participants with radiological evidence of intracranial metastatic disease (IMD) on standard of care contrast-enhanced magnetic resonance imaging (CE-MRI) that had completed stereotactic radiosurgery (SRS) (+/- combination therapy) within 4-8 weeks of \[18F\]FPIA PET-mMRI. Participants enrolled into the study had either one or two \[18F\]FPIA positron emission tomography-multiparametric magnetic resonance imaging (PET-mMRI) scans performed at the Invicro, Centre for Imaging Sciences. A single intravenous dose of \[18F\]FPIA (maximum, 370MBq) was administered to the participant followed by a whole brain dynamic PET-MRI scan over 66 minutes.
Quantitative Measurement of [18F]FPIA Uptake Within the Cerebral Metastases of Treatment naïve Patients. T1 mask	1.54 SUV_max (kBq/L/kBq/g) Standard Deviation 0.41	—
Quantitative Measurement of [18F]FPIA Uptake Within the Cerebral Metastases of Treatment naïve Patients. SUV40 mask	1.47 SUV_max (kBq/L/kBq/g) Standard Deviation 0.33	—
Quantitative Measurement of [18F]FPIA Uptake Within the Cerebral Metastases of Treatment naïve Patients. SUV30 mask	1.48 SUV_max (kBq/L/kBq/g) Standard Deviation 0.33	—

PRIMARY outcome

Timeframe: On the scan day (4-8 weeks post-SRS treatment)

Outcome measures

Outcome measures
Measure	[18F]FPIA PET-mMRI Scans Performed on Patients With Treatment-naive IMD on CE-MRI. n=18 Lesions Participants with radiological evidence of intracranial metastatic disease (IMD) on standard of care contrast-enhanced magnetic resonance imaging (CE-MRI) that were treatment-naive for their IMD at the time of enrolment/\[18F\]FPIA PET-mMRI scan. Participants enrolled into the treatment-naive cohort that went onto have stereotactic radiosurgery (SRS) could also provide written informed consent to be scanned within the 4-8 weeks post-SRS cohort. Participants enrolled into the study had either one or two \[18F\]FPIA positron emission tomography-multiparametric magnetic resonance imaging (PET-mMRI) scans performed at the Invicro, Centre for Imaging Sciences. A single intravenous dose of \[18F\]FPIA (maximum, 370MBq) was administered to the participant followed by a whole brain dynamic PET-MRI scan over 66 minutes.	[18F]FPIA PET-mMRI Scans Performed on Patients With IMD on CE-MRI That Had Undergone SRS Treatment. Participants with radiological evidence of intracranial metastatic disease (IMD) on standard of care contrast-enhanced magnetic resonance imaging (CE-MRI) that had completed stereotactic radiosurgery (SRS) (+/- combination therapy) within 4-8 weeks of \[18F\]FPIA PET-mMRI. Participants enrolled into the study had either one or two \[18F\]FPIA positron emission tomography-multiparametric magnetic resonance imaging (PET-mMRI) scans performed at the Invicro, Centre for Imaging Sciences. A single intravenous dose of \[18F\]FPIA (maximum, 370MBq) was administered to the participant followed by a whole brain dynamic PET-MRI scan over 66 minutes.
Quantitative Measurement of [18F]FPIA Uptake Within the Cerebral Metastases of Patients Treated With Stereotactic Radiosurgery (SRS). T1 mask	1.45 SUVmax (kBq/L/kBq/g) Standard Deviation 0.65	—
Quantitative Measurement of [18F]FPIA Uptake Within the Cerebral Metastases of Patients Treated With Stereotactic Radiosurgery (SRS). SUV30 mask	1.17 SUVmax (kBq/L/kBq/g) Standard Deviation 0.54	—
Quantitative Measurement of [18F]FPIA Uptake Within the Cerebral Metastases of Patients Treated With Stereotactic Radiosurgery (SRS). SUV40 mask	1.15 SUVmax (kBq/L/kBq/g) Standard Deviation 0.56	—

SECONDARY outcome

Timeframe: On the scan day (4-8 weeks post-SRS treatment)

Tumour-to-contralateral white matter (CWM) ratio (TBR) 60 minutes post-injection of \[18F\]FPIA using PET/MRI. Regions of interest for quantification were identified by an experienced neuroradiologist. For each subject, two volumes of interest (VOI) were created. A VOI was drawn around the lesion, plus a contralateral VOI of the same volume in healthy brain was measured for comparison using a T1-MRI mask, SUV30 mask and SUV40 mask. The maximum standardised uptake value (SUVmax) of \[18F\]FPIA within the tissues was calculated using the last PET frame at 60 minutes. SUV30 and SUV40 masks (30 and 40% of the SUVmax value at 60 minutes) were derived to determine image overlap.

Outcome measures

Outcome measures
Measure	[18F]FPIA PET-mMRI Scans Performed on Patients With Treatment-naive IMD on CE-MRI. n=17 Lesions Participants with radiological evidence of intracranial metastatic disease (IMD) on standard of care contrast-enhanced magnetic resonance imaging (CE-MRI) that were treatment-naive for their IMD at the time of enrolment/\[18F\]FPIA PET-mMRI scan. Participants enrolled into the treatment-naive cohort that went onto have stereotactic radiosurgery (SRS) could also provide written informed consent to be scanned within the 4-8 weeks post-SRS cohort. Participants enrolled into the study had either one or two \[18F\]FPIA positron emission tomography-multiparametric magnetic resonance imaging (PET-mMRI) scans performed at the Invicro, Centre for Imaging Sciences. A single intravenous dose of \[18F\]FPIA (maximum, 370MBq) was administered to the participant followed by a whole brain dynamic PET-MRI scan over 66 minutes.	[18F]FPIA PET-mMRI Scans Performed on Patients With IMD on CE-MRI That Had Undergone SRS Treatment. n=18 Lesions Participants with radiological evidence of intracranial metastatic disease (IMD) on standard of care contrast-enhanced magnetic resonance imaging (CE-MRI) that had completed stereotactic radiosurgery (SRS) (+/- combination therapy) within 4-8 weeks of \[18F\]FPIA PET-mMRI. Participants enrolled into the study had either one or two \[18F\]FPIA positron emission tomography-multiparametric magnetic resonance imaging (PET-mMRI) scans performed at the Invicro, Centre for Imaging Sciences. A single intravenous dose of \[18F\]FPIA (maximum, 370MBq) was administered to the participant followed by a whole brain dynamic PET-MRI scan over 66 minutes.
Distribution of [18F]FPIA Uptake in Lesions Which Have Undergone Treatment, With Those That Are Treatment naïve. T1 mask	3.75 TBRmax Standard Deviation 1.16	3.97 TBRmax Standard Deviation 1.82
Distribution of [18F]FPIA Uptake in Lesions Which Have Undergone Treatment, With Those That Are Treatment naïve. SUV40 mask	3.71 TBRmax Standard Deviation 1.21	3.85 TBRmax Standard Deviation 1.99
Distribution of [18F]FPIA Uptake in Lesions Which Have Undergone Treatment, With Those That Are Treatment naïve. SUV30 mask	3.73 TBRmax Standard Deviation 1.19	3.90 TBRmax Standard Deviation 1.94

Adverse Events

Patients With Radiological Evidence of IMD That Are Treatment Naive.

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Participants With Radiological Evidence of IMD That Had Completed SRS.

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Eric Aboagye

Imperial College London

Phone: 0203 313 3720

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place