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Cerebral metastases represent a significant problem for oncological management. It is estimated that 20-40% of patients with cancer will develop metastatic cancer to the brain during the course of their illness. 18F-fluoropivalate ([18F]FPIA) is a new tracer that images short chain fatty acid (SCFA) uptake in tumours, a key component of fatty acid oxidation.
The aim of this study is to quantify the degree of early step fatty acid oxidation in cerebral metastases as imaged by [18F]FPIA Positron Emission Tomography (PET)/Magnetic Resonance Imaging (MRI).
The investigators hypothesise that FPIA uptake will be higher in metastases that are treatment naïve compared to those that have undergone treatment, in keeping with viable tumour cells having a high propensity to generate ATP and NADPH via fatty acid oxidation under bioenergetic stress.
24 evaluable patients with radiological evidence of cerebral metastases on MRI will be enrolled into the study (12 who are treatment naïve + 12 who have completed Stereotactic Radiosurgery (SRS)+/- combination therapy). The patients invited to participate in the study will provide written informed consent. [18F]FPIA PET/MRI imaging will only be performed once patients have satisfied the inclusion and exclusion criteria. Once these have been satisfied, eligible patients will proceed to [18F]FPIA PET/MRI.
On the day of imaging the patients will undergo a blood test to measure plasma concentrations of carnitine (approximately 6mls). During the scan, a single dose of [18F]FPIA (maximum, 370 MBq) IV will be administered to the participant followed by a whole brain dynamic PET/MRI scan over 66 minutes. During the MRI sequences, the patient will receive a 2 stage IV bolus of Gadolinium contrast medium administered through a peripheral venous cannula.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]FPIA PET/MRI | Other | 18F-fluoropivalate tracer injection followed by PET/MRI scan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative Measurement of [18F]FPIA Uptake Within the Cerebral Metastases of Treatment naïve Patients. | 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. | On the scan day up to 60 minutes |
| Quantitative Measurement of [18F]FPIA Uptake Within the Cerebral Metastases of Patients Treated With Stereotactic Radiosurgery (SRS). | 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. | On the scan day (4-8 weeks post-SRS treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of [18F]FPIA Uptake in Lesions Which Have Undergone Treatment, With Those That Are Treatment naïve. | 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. |
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Inclusion Criteria:
A) Treatment naïve
or
B) SRS+/- combination treated - Patients that have completed the SRS part of a combination regime enabling a 4-8 week post-SRS treatment PET/MRI scan.
and
C) That fulfil the following criteria:
Exclusion Criteria:
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Patients with radiological evidence of cerebral metastases on MRI that are either treatment naïve or have been treated with SRS +/- combination therapy within 4-8 weeks.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College Healthcare NHS Trust | London | W12 0HS | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39915301 | Derived | Islam S, Inglese M, Aravind P, Barwick TD, Mauri F, McLeavy L, Arstad E, Wang J, Puccio I, Hung L, Lu H, O'Neill K, Waldman AD, Williams M, Aboagye EO. A hybrid [18F]fluoropivalate PET-multiparametric MRI to detect and characterise brain tumour metastases based on a permissive environment for monocarboxylate transport. Eur J Nucl Med Mol Imaging. 2025 Jun;52(7):2290-2306. doi: 10.1007/s00259-025-07118-0. Epub 2025 Feb 7. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Quantitative Measurement of [18F]FPIA Uptake Within the Cerebral Metastases of Treatment naïve Patients. | 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. | Posted | Mean | Standard Deviation | SUV_max (kBq/L/kBq/g) | On the scan day up to 60 minutes | Lesions | Lesions |
|
All adverse events were reported that had taken place up to 24 hours post injection of [18F]FPIA.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 for their IMD at the time of enrolment/[18F]FPIA positron emission tomography-multiparametic magnetic resonance imaging (PET-mpMRI) scanning. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Eric Aboagye | Imperial College London | 0203 313 3720 | eric.aboagye@imperial.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 8, 2022 | Jul 1, 2024 | Prot_SAP_000.pdf |
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Blood sample taken for carnitine analysis.
|
| On the scan day (4-8 weeks post-SRS treatment) |
| BG001 | 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 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Extracranial tumour of origin | Count of Participants | Participants |
|
|
|
| Primary | Quantitative Measurement of [18F]FPIA Uptake Within the Cerebral Metastases of Patients Treated With Stereotactic Radiosurgery (SRS). | 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. | Posted | Mean | Standard Deviation | SUVmax (kBq/L/kBq/g) | On the scan day (4-8 weeks post-SRS treatment) | Lesions | Lesions |
|
|
|
| Secondary | Distribution of [18F]FPIA Uptake in Lesions Which Have Undergone Treatment, With Those That Are Treatment naïve. | 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. | Posted | Mean | Standard Deviation | TBRmax | On the scan day (4-8 weeks post-SRS treatment) | Lesions | Lesions |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Participants With Radiological Evidence of IMD That Had Completed SRS. | Patients 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 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. | 0 | 10 | 0 | 10 | 0 | 10 |
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| Title | Measurements |
|---|---|
|
| SUV30 mask |
|