Trial Outcomes & Findings for Measuring Fatty Acid Oxidation in Gliomas Using 18F-FPIA PET/MRI (NCT NCT04097535)

NCT ID: NCT04097535

Last Updated: 2024-11-21

Results Overview

Standardised uptake values (SUV) on \[18F\]FPIA PET/MRI

• Recruitment status: COMPLETED
• Target enrollment: 11 participants
• Primary outcome timeframe: -21-0 days
• Results posted on: 2024-11-21

Participant Flow

The study was open to recruitment from the 04Jun2018 to 07Aug2020. Intervention: [18F]FPIA injection and multi-parametric, multi-modal dynamic PET-MRI performed at Imanova Limited, Burlington Danes, Imperial College London (Hammersmith Hospital Campus), Du Cane Road, London, W12 0NN. The key objective of this study was to quantify the magnitude of the early steps fatty acid oxidation in human gliomas using [18F]FPIA PET/MRI.

Participant milestones

Measure	Patients With a Suspected Cerebral Glioma on Standard of Care MRI Participants with a suspected cerebral glioma on standard of care imaging that are enrolled into the study had an \[18F\]FPIA PET-MRI scan performed at Imanova Limited on a Signa™ 3.0 T scanner. All participants enrolled into the study subsequently underwent a biopsy or surgical resection as part of their routine clinical care. Tissue obtained post-procedure (surgical resection/biopsy) to determine tumour grade and perform metabolomics, genomics, and proteomics. PET-MRI Protocol: Subjects received a single I.V bolus injection of \[18F\]FPIA followed by a saline flush. A single dose of \[18F\]FPIA (maximum 370MBq) was administered followed by a whole brain dynamic PET-MRI scan over 66 minutes. During the MRI sequences, the patients received an additional I.V bolus of Gadolinium contrast-medium administered through a peripheral venous cannula. MRI: Sequences for attenuation correction of PET data (DIXON, zero-TE), volumetric T1-weighted images (pre- and post-contrast administration), volumetric T2, dynamic susceptibility contrast perfusion (DSC) and dynamic contrast enhanced perfusion (DCE). * Maximum Injected Activity: 370MBq * Conversion Factor (mSv/MBq): 0.0187 * Total Effective Dose (mSv)/patient: 6.9 mSv The total effective dose for each patient in this study is 6.9 mSv. There is no ionising radiation from the MR component of the study.
Overall Study STARTED	11
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure

Patients With a Suspected Cerebral Glioma on Standard of Care MRI Participants with a suspected cerebral glioma on standard of care imaging that are enrolled into the study had an \[18F\]FPIA PET-MRI scan performed at Imanova Limited on a Signa™ 3.0 T scanner. All participants enrolled into the study subsequently underwent a biopsy or surgical resection as part of their routine clinical care. Tissue obtained post-procedure (surgical resection/biopsy) to determine tumour grade and perform metabolomics, genomics, and proteomics. PET-MRI Protocol: Subjects received a single I.V bolus injection of \[18F\]FPIA followed by a saline flush. A single dose of \[18F\]FPIA (maximum 370MBq) was administered followed by a whole brain dynamic PET-MRI scan over 66 minutes. During the MRI sequences, the patients received an additional I.V bolus of Gadolinium contrast-medium administered through a peripheral venous cannula. MRI: Sequences for attenuation correction of PET data (DIXON, zero-TE), volumetric T1-weighted images (pre- and post-contrast administration), volumetric T2, dynamic susceptibility contrast perfusion (DSC) and dynamic contrast enhanced perfusion (DCE). * Maximum Injected Activity: 370MBq * Conversion Factor (mSv/MBq): 0.0187 * Total Effective Dose (mSv)/patient: 6.9 mSv The total effective dose for each patient in this study is 6.9 mSv. There is no ionising radiation from the MR component of the study.

Overall Study [18F]FPIA/radiotracer production failure - Participant subsequently withdrew consent.

1

Baseline Characteristics

Measuring Fatty Acid Oxidation in Gliomas Using 18F-FPIA PET/MRI

Baseline characteristics by cohort

Measure	Patients With a Suspected Cerebral Glioma on Standard of Care MRI n=10 Participants Participants was a suspected cerebral glioma on standard of care imaging that are enrolled into the study had an \[18F\]FPIA PET-MRI scan performed at Imanova Limited on a Signa™ 3.0 T scanner. All participants enrolled into the study subsequently underwent a biopsy or surgical resection as part of their routine clinical care. Tissue obtained post-procedure (surgical resection/biopsy) to determine tumour grade and perform metabolomics, genomics, and proteomics. PET-MRI Protocol: Subjects received a single I.V bolus injection of \[18F\]FPIA followed by a saline flush. A single dose of \[18F\]FPIA (maximum 370MBq) was administered followed by a whole brain dynamic PET-MRI scan over 66 minutes. During the MRI sequences, the patients received an additional I.V bolus of Gadolinium contrast-medium administered through a peripheral venous cannula. MRI: Sequences for attenuation correction of PET data (DIXON, zero-TE), volumetric T1-weighted images (pre- and post-contrast administration), volumetric T2, dynamic susceptibility contrast perfusion (DSC) and dynamic contrast enhanced perfusion (DCE). * Maximum Injected Activity: 370MBq * Conversion Factor (mSv/MBq): 0.0187 * Total Effective Dose (mSv)/patient: 6.9 mSv The total effective dose for each patient in this study is 6.9 mSv. There is no ionising radiation from the MR component of the study.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age, Continuous	59.7 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 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	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: -21-0 days

Standardised uptake values (SUV) on [18F]FPIA PET/MRI

Outcome measures

Measure	Patients With a Histologically Confirmed Grade II Glioma. n=2 Participants Participants with a suspected cerebral glioma on standard of care imaging that underwent an \[18F\]FPIA PET-MRI scan prior to routine biopsy/surgical resection. Tissue obtained post-procedure provided histological confirmation of a grade II glioma.	Patients With a Histologically Confirmed Grade III Glioma. n=3 Participants Participants with a suspected cerebral glioma on standard of care imaging that underwent an \[18F\]FPIA PET-MRI scan prior to routine biopsy/surgical resection. Tissue obtained post-procedure provided histological confirmation of a grade III glioma.	Patients With a Histologically Confirmed Grade IV Glioma. n=5 Participants Participants with a suspected cerebral glioma on standard of care imaging that underwent an \[18F\]FPIA PET-MRI scan prior to routine biopsy/surgical resection. Tissue obtained post-procedure provided histological confirmation of a grade IV glioma.
Quantitative Measurement of [18F]-FPIA Uptake in Human Gliomas	0.9041 SUV60_max Interval 0.8974 to 0.9108	1.3529 SUV60_max Interval 1.152 to 1.591	2.0470 SUV60_max Interval 1.6564 to 2.6358

SECONDARY outcome

Timeframe: 0-3 months

Population: Five participants enrolled into the study were patients with a histologically confirmed grade IV glioma. IDH status and MGMT status were assessed separately using immunohistochemistry (IHC) for the five participants with a grade IV glioma.

[18F]FPIA PET/MRI & Immunohistochemistry (IHC)

Outcome measures

Measure	Patients With a Histologically Confirmed Grade II Glioma. n=2 Participants Participants with a suspected cerebral glioma on standard of care imaging that underwent an \[18F\]FPIA PET-MRI scan prior to routine biopsy/surgical resection. Tissue obtained post-procedure provided histological confirmation of a grade II glioma.	Patients With a Histologically Confirmed Grade III Glioma. n=3 Participants Participants with a suspected cerebral glioma on standard of care imaging that underwent an \[18F\]FPIA PET-MRI scan prior to routine biopsy/surgical resection. Tissue obtained post-procedure provided histological confirmation of a grade III glioma.	Patients With a Histologically Confirmed Grade IV Glioma. n=5 Participants Participants with a suspected cerebral glioma on standard of care imaging that underwent an \[18F\]FPIA PET-MRI scan prior to routine biopsy/surgical resection. Tissue obtained post-procedure provided histological confirmation of a grade IV glioma.
Correlation of 18F-FPIA Uptake With Tumour Type and Histological Grade Including O6-methylguanine-DNA Methyltransferase (MGMT) and Isocitrate Dehydrogenase (IDH) Gene Expression. IDH Status - IDH mutant	2 participants	3 participants	0 participants
Correlation of 18F-FPIA Uptake With Tumour Type and Histological Grade Including O6-methylguanine-DNA Methyltransferase (MGMT) and Isocitrate Dehydrogenase (IDH) Gene Expression. IDH Status - IDH wild-type	0 participants	0 participants	5 participants
Correlation of 18F-FPIA Uptake With Tumour Type and Histological Grade Including O6-methylguanine-DNA Methyltransferase (MGMT) and Isocitrate Dehydrogenase (IDH) Gene Expression. MGMT Status - MGMT Methylated	—	—	3 participants
Correlation of 18F-FPIA Uptake With Tumour Type and Histological Grade Including O6-methylguanine-DNA Methyltransferase (MGMT) and Isocitrate Dehydrogenase (IDH) Gene Expression. MGMT Status - MGMT Unmethylated	—	—	2 participants

Adverse Events

Patients With a Suspected Cerebral Glioma on Standard of Care MRI

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: 02083833759

Email: eric.aboagye@imperial.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place