Cerebral MetastasesNCT04807582
Measuring Fatty Acid Oxidation in Cerebral Metastases Using [18F]FPIA
An observational study of Cerebral Metastases, run by Imperial College London at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Metastases
- What is being tested?
- [18F]FPIA PET/MRI
- Type of treatment
- Injection or infusion
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Sep 2020to 1 Mar 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Treatment naïve
- or
- 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
- That fulfil the following criteria:
- Age ≥18.
Show all 12Show fewer
- Target metastases size ≥ 1cm.
- WHO performance status 0 - 2.
- If female, the subject is either post-menopausal (at least 1 year), or surgically sterilized (has had a documented bilateral oophorectomy and/or documented hysterectomy for at least 2 years), or if of childbearing potential, must have a negative urine beta human chorionic gonadotropin (beta-hCG) pregnancy test done prior to tracer administration.
- The subject is able and willing to comply with study procedures, and signed and dated informed consent is obtained.
- The subject has a satisfactory medical history as judged by the investigator with no significant co-morbidities.
- The subject's clinical and laboratory tests are within normal limits and/or considered clinically insignificant.
Who cannot join
- The subject is pregnant or lactating.
- Any other chronic illness that will or musculoskeletal condition that would not allow comfortable performance of a PET study.
- Prior use within 14 days of enrolment or concurrent therapy with any other investigational agent.
- Unsatisfactory renal function (eGFR<30).
- The subject has non-MRI compatible devices (e.g.a pacemaker, an implantable cardioverter-defibrillator (ICD), a nerve stimulator, a cochlear implant or a drug pump) or implanted material (e.g. non-MRI compatible sternal wires, biostimulators, metals or alloys).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College Healthcare NHS Trust
London, W12 0HS
About this study
Official title: Determining the Magnitude of Early Steps of Fatty Acid Oxidation in Cerebral Metastases Using [18F]FPIA PET/MRI
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.
Read the detailed description
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.
- Conditions
- Cerebral Metastases
- Being tested
- [18F]FPIA PET/MRI
- Keywords
- PET/MRI, Fatty Acid Oxidation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]FPIA PET/MRIOther
Also called Imaging Scan
18F-fluoropivalate tracer injection followed by PET/MRI scan
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: [18F]FPIA PET/MRI | |
| 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. Receives: Other: [18F]FPIA PET/MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: On the scan day (4-8 weeks post-SRS treatment)
Secondary outcomes (1)
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.
Measured: On the scan day (4-8 weeks post-SRS treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start25 Sep 2020
- Primary completion30 Jun 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral MetastasesStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807582
- Sponsor's protocol ID
- 19CX5551
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2021
- Last updated
- 2 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39915301
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Magnitude of Early Steps of Fatty Acid Oxidation in Cerebral Metastases Using [18F]FPIA PET/MRI
- ClinicalTrials.gov ID
- NCT04807582
- Acronym / sponsor ID
- 19CX5551
- Conditions
- Cerebral Metastases
- Keywords
- PET/MRI, Fatty Acid Oxidation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 19 Mar 2021 (actual)
- Results
- Posted 2 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients With Radiological Evidence of IMD That Are Treatment Naive. | – | Other: [18F]FPIA PET/MRIParticipants 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. | – | Other: [18F]FPIA PET/MRIParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (12 listed)
- Treatment naïve
- or
- 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
- That fulfil the following criteria:
Key exclusion criteria (5 listed)
- The subject is pregnant or lactating.
- Any other chronic illness that will or musculoskeletal condition that would not allow comfortable performance of a PET study.
- Prior use within 14 days of enrolment or concurrent therapy with any other investigational agent.
- Unsatisfactory renal function (eGFR<30).
- The subject has non-MRI compatible devices (e.g.a pacemaker, an implantable cardioverter-defibrillator (ICD), a nerve stimulator, a cochlear implant or a drug pump) or implanted material (e.g. non-MRI compatible sternal wires, biostimulators, metals or alloys).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]FPIA PET/MRIAlso: Imaging Scan18F-fluoropivalate tracer injection followed by PET/MRI scan | Other | Patients With Radiological Evidence of IMD That Are Treatment Naive., Patients With Radiological Evidence of IMD That Had Completed Stereotactic Radiosurgery. |
Primary outcome
Quantitative Measurement of [18F]FPIA Uptake Within the Cerebral Metastases of Treatment naïve Patients.
Time frame: On the scan day up to 60 minutes
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.
Quantitative Measurement of [18F]FPIA Uptake Within the Cerebral Metastases of Patients Treated With Stereotactic Radiosurgery (SRS).
Time frame: On the scan day (4-8 weeks post-SRS treatment)
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.
1 secondary outcome
Distribution of [18F]FPIA Uptake in Lesions Which Have Undergone Treatment, With Those That Are Treatment naïve.
Time frame: On the scan day (4-8 weeks post-SRS treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39915301Islam 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Metastases, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative Measurement of [18F]FPIA Uptake Within the Cerebral Metastases of Treatment naïve Patients. (time frame: On the scan day up to 60 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04807582, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.