Metastatic Renal Cell CarcinomaNCT04802824
Measuring Treatment Response in Metastatic Renal Cell Cancer Using FPIA PET/CT
An observational study of Metastatic Renal Cell Carcinoma, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Renal cell carcinoma (RCC) is the most prevalent and lethal malignancy of the kidney. At the time of diagnosis, as many as a fifth of patients have metastatic disease (mRCC). Despite advances in treatment, long-term survival rates remain poor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cell Carcinoma
- What is being tested?
- PET/CT
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 May 2021to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 and/or histological evidence of mRCC and due to receive systemic therapy.
Who may be able to join
- Patients with radiological and/or histological evidence of evidence of mRCC who are either:
- Treatment naïve or newly relapsed (not currently on treatment)
- or
- Progressing on standard of care systemic therapy
- and
- That fulfil the following criteria:
Show all 14Show fewer
- Age ≥18
- Target metastases size ≥ 1cm (outside of the liver).
- The subject has an available diagnostic tumour biopsy of the primary and/or metastatic lesion taken within 3 months of the first [18F]FPIA PET/CT.
- WHO performance status 0 - 2.
- If female, the subject is either post-menopausal (>1 year), or surgically sterilized (has had a documented bilateral oophorectomy and/or documented hysterectomy, >2 years), or if of childbearing potential, must have a negative urine pregnancy test at initial screening and/or within 2 hours prior to injection of imaging agent.
- eGFR of ≥30 within 3 months of [18F]FPIA injection
- The subject is able and willing to comply with study procedures, and a signed and dated informed consent is obtained.
- The subject is not scheduled to start cancer treatment prior to the first study PET/CT scan.
Who cannot join
- Pregnant or lactating women
- Evidence of significant medical condition or laboratory finding which, in the opinion of the Investigator, makes it undesirable for the patient to participate in the trial
- The subject is receiving or has received chemotherapy, immunotherapy, biologic therapy or investigational therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of [18F]FPIA injection.
- The subject is scheduled to have a nuclear medicine or contrast scan within 24 hours of the administration of [18F]FPIA.
- Participants with claustrophobia or who are unable to comfortably tolerate the scanning procedure.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College Healthcare NHS Trust/Imperial College London
London, W12 0HS
About this study
Official title: Determining the Magnitude of Change in [18F]FPIA-detectable Short Chain Fatty Acid Uptake in Metastatic Renal Cell Cancer Following Therapy
Renal cell carcinoma (RCC) is the most prevalent and lethal malignancy of the kidney. At the time of diagnosis, as many as a fifth of patients have metastatic disease (mRCC). Despite advances in treatment, long-term survival rates remain poor. 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 the study is to investigate longitudinal changes in [18F]FPIA uptake at baseline, at 4-6 weeks and at 12 weeks following treatment initiation in patients using tyrosine kinase inhibitors (TKI's), chemotherapy, immunotherapy, or combinations of these.
The investigators hypothesise that the import of [18F]FPIA-detectable SCFA into tumours is high and decreases with effective treatment.
Read the detailed description
24 evaluable patients with radiological and/or histological evidence of mRCC and due to receive systemic therapy will be enrolled. The patients invited to participate in the study will provide written informed consent. Patients will only undergo [18F]FPIA positron emission tomography (PET)/computed tomography (CT) imaging once they have satisfied the inclusion and exclusion criteria. Once these have been satisfied, eligible patients will proceed to [18F]FPIA PET/CT. Patients will have three imaging visits at baseline, 4-6 weeks and 12 weeks post the commencement of treatment. Patients will have been treated as per standard of care, which may have included TKI's, chemotherapy, immunotherapy or combinations of these. Data will be considered complete when patients have all three analysable scans. In the event of dropout, additional subjects will be recruited to reach a total number of 24 evaluable subjects.
On each day of imaging the patients will have a blood test and a urine sample collected to measure concentrations of carnitine. For each scan, a single dose of [18F]FPIA (maximum 370 MBq) IV will be administered to the participant. The participant will then rest in a quiet place for an uptake period and undergo whole body PET/CT scanning from 60 minutes.
Archival tumour biopsies (primary or metastatic lesion), taken within 3 months of the 1st [18F]FPIA PET/CT scan will be retrieved for analysis where possible.
- Conditions
- Metastatic Renal Cell Carcinoma
- Being tested
- PET/CT
- Keywords
- PET/CT, Fatty Acid Oxidation
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CTOther
Also called Imaging Scan
18F-fluoropivalate PET/CT scan.
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative longitudinal measurement of [18F]FPIA uptake in mRCC.
PET/CT
Measured: Baseline, 4-6 weeks and 12 weeks post-commencement of treatment.
Secondary outcomes (2)
Quantitative measurement of FPIA in healthy tissue including kidneys.
PET/CT
Measured: Baseline, 4-6 weeks and 12 weeks post-commencement of treatment.
Comparison of [18F]FPIA relative to baseline at 4-6 weeks and at 12 weeks (± 4 weeks) to changes on a patient's routine imaging scan.
Routine Imaging Scans - Determined by the NHS Treating Clinician.
Measured: Baseline, 4-6 weeks and 12 weeks post-commencement of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start25 May 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Renal Cell CarcinomaStudies 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
- 10 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
- NCT04802824
- Sponsor's protocol ID
- 20CX6143
- Status last verified
- Apr 2025
- First submitted
- 11 Mar 2021
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Magnitude of Change in [18F]FPIA-detectable Short Chain Fatty Acid Uptake in Metastatic Renal Cell Cancer Following Therapy
- ClinicalTrials.gov ID
- NCT04802824
- Acronym / sponsor ID
- 20CX6143
- Conditions
- Metastatic Renal Cell Carcinoma
- Keywords
- PET/CT, Fatty Acid Oxidation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 25 May 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 17 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Renal cell carcinoma (RCC) is the most prevalent and lethal malignancy of the kidney. At the time of diagnosis, as many as a fifth of patients have metastatic disease (mRCC). Despite advances in treatment, long-term survival rates remain poor. 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 the study is to investigate longitudinal changes in [18F]FPIA uptake at baseline, at 4-6 weeks and at 12 weeks following treatment initiation in patients using tyrosine kinase inhibitors (TKI's), chemotherapy, immunotherapy, or combinations of these.
The investigators hypothesise that the import of [18F]FPIA-detectable SCFA into tumours is high and decreases with effective treatment.
Detailed description
24 evaluable patients with radiological and/or histological evidence of mRCC and due to receive systemic therapy will be enrolled. The patients invited to participate in the study will provide written informed consent. Patients will only undergo [18F]FPIA positron emission tomography (PET)/computed tomography (CT) imaging once they have satisfied the inclusion and exclusion criteria. Once these have been satisfied, eligible patients will proceed to [18F]FPIA PET/CT. Patients will have three imaging visits at baseline, 4-6 weeks and 12 weeks post the commencement of treatment. Patients will have been treated as per standard of care, which may have included TKI's, chemotherapy, immunotherapy or combinations of these. Data will be considered complete when patients have all three analysable scans. In the event of dropout, additional subjects will be recruited to reach a total number of 24 evaluable subjects.
On each day of imaging the patients will have a blood test and a urine sample collected to measure concentrations of carnitine. For each scan, a single dose of [18F]FPIA (maximum 370 MBq) IV will be administered to the participant. The participant will then rest in a quiet place for an uptake period and undergo whole body PET/CT scanning from 60 minutes.
Archival tumour biopsies (primary or metastatic lesion), taken within 3 months of the 1st [18F]FPIA PET/CT scan will be retrieved for analysis where possible.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with radiological and/or histological evidence of mRCC and due to receive systemic therapy.
Key inclusion criteria (14 listed)
- Patients with radiological and/or histological evidence of evidence of mRCC who are either:
- Treatment naïve or newly relapsed (not currently on treatment)
- or
- Progressing on standard of care systemic therapy
- and
Key exclusion criteria (5 listed)
- Pregnant or lactating women
- Evidence of significant medical condition or laboratory finding which, in the opinion of the Investigator, makes it undesirable for the patient to participate in the trial
- The subject is receiving or has received chemotherapy, immunotherapy, biologic therapy or investigational therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of [18F]FPIA injection.
- The subject is scheduled to have a nuclear medicine or contrast scan within 24 hours of the administration of [18F]FPIA.
- Participants with claustrophobia or who are unable to comfortably tolerate the scanning procedure.
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 |
|---|---|---|
| PET/CTAlso: Imaging Scan18F-fluoropivalate PET/CT scan. | Other | – |
Primary outcome
Quantitative longitudinal measurement of [18F]FPIA uptake in mRCC.
Time frame: Baseline, 4-6 weeks and 12 weeks post-commencement of treatment.
PET/CT
2 secondary outcomes
Quantitative measurement of FPIA in healthy tissue including kidneys.
Time frame: Baseline, 4-6 weeks and 12 weeks post-commencement of treatment.
Comparison of [18F]FPIA relative to baseline at 4-6 weeks and at 12 weeks (± 4 weeks) to changes on a patient's routine imaging scan.
Time frame: Baseline, 4-6 weeks and 12 weeks post-commencement of treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- 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 Metastatic Renal Cell Carcinoma, 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 14 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 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 longitudinal measurement of [18F]FPIA uptake in mRCC. (time frame: Baseline, 4-6 weeks and 12 weeks post-commencement of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2025.