GliomaFIGNCT04870580
[18F] FDOPA PET Imaging in Glioma: Feasibility Study for PET Guided Brain Biopsy
A study testing Fluorodopa PET tracer in people with Glioma, run by University College, London at 1 site in United Kingdom.
Trial summary
[18F]fluorodopa (3, 4-dihydroxy-6-[18F]fluoro-L-phenylalanine/ FDOPA) is an amino acid PET tracer originally developed for brain imaging in patients with movement disorders but has been found to be useful in brain tumour imaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- What is being tested?
- Fluorodopa PET tracer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2021to 1 May 2024
- Phase
- Interventional
- 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
Who may be able to join
- Age over 18 years
- Diagnosed with low-grade glioma based on clinical standard of care imaging and scheduled for primary surgical resection of low-grade glioma
- Females of childbearing potential and males agree to use an effective method of contraception from the time consent is signed until 1 week after surgery.
- Females of childbearing potential have a negative urine pregnancy test within 7 days prior to being registered. Participants are considered not of child bearing potential if they are surgically sterile (i.e. they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal
- Willing and able to provide written informed consent
Who cannot join
- Females who are pregnant, planning pregnancy or breastfeeding
- Concurrent and/or recent involvement in other research or use of another experimental investigational medicinal product that is likely to interfere with the study medication within 28 days of study enrolment.
- MRI contraindicated (e.g. implanted electric and electronic devices, heart pacemakers, insulin pumps, implanted hearing aids, neurostimulators, intracranial metal clips, metallic bodies in the eye).
- Other psychological, social or medical condition, physical examination finding or a laboratory abnormality that the Investigator considers would make the patient a poor study candidate or could interfere with protocol compliance or the interpretation of study results.
- Neoadjuvant chemotherapy/radiotherapy treatment for low-grade glioma which would interfere with the interpretation of study results.
- Any other problems that may make the patient unable to tolerate the PET scans (e.g. claustrophobia).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, OX3 9DU
About this study
[18F]fluorodopa (3, 4-dihydroxy-6-[18F]fluoro-L-phenylalanine/ FDOPA) is an amino acid PET tracer originally developed for brain imaging in patients with movement disorders but has been found to be useful in brain tumour imaging. [18F]fluorodopa has been demonstrated to be predominantly transported by the L-type amino acid transporter without significant uptake into surrounding normal brain parenchyma with the exception of the basal ganglia. Assessing the feasibility of performing PET guided histopathology in a single and multi-site setting will be crucial in order to use PET as a planning tool for brain biopsy to detect high-grade transformation in low-grade gliomas.
Read the detailed description
Glioma is a cancer of unmet need, where survival trends have not significantly changed for decades. The distinction between high-grade (HGG) and low-grade glioma (LGG) is important as both entities confer different prognoses and management strategies. This distinction is normally made on biopsy sampling and conventional imaging. However, sampling errors are not uncommon due to the heterogeneous nature of glioma. Case series have described under-grading of gliomas on biopsy in 28% to 63% of cases. Furthermore, up to one third of high-grade gliomas may not display the typical imaging characteristics (enhancement) of a high-grade glioma. Therefore, more accurate imaging may help to make this distinction and guide biopsy and clinical management decisions at the outset.
There has been growing interest in the use of amino acid PET in glioma imaging. Transport of amino acids across the blood brain barrier and low physiological levels of tracer uptake within the brain allow for good tumour visualisation. The most frequently used amino acid PET tracers described in clinical literature are [11C]methionine, [18F]fluoroethyltyrosine and [18F]fluorodopa, which predominantly reflect leucine transport, being mainly transported by LAT1, a high affinity leucine transporter. Alongside depiction of tumour volume, described roles of amino acid PET include differentiation of true disease progression from pseudo progression, detection of residual disease in the post-surgical patient, biopsy guidance and prognostication.
Rationale The primary objective of the study will be to establish the feasibility of performing [18F]fluorodopa PET guided histopathology in a single and multi-site setting. Basic tumour characterisation (for example Ki67 expression and detection of IDH mutations) will be undertaken.
- Conditions
- Glioma
- Being tested
- Fluorodopa PET tracer
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorodopa PET tracerDiagnostic test
PET/CT scan using fluorodopa tracer
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Other | PET/CT with fluorodopa tracer Receives: Diagnostic Test: Fluorodopa PET tracer |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the feasibility of PET guided histopathology in a single and multi-site setting.
Assessment of tumour standardised uptake values (SUV) from [18F]fluorodopa PET with matched histopathology data from biopsies for evaluable patients from a single site and multiple sites. The percentage of cases where it is possible to collect this data will inform the feasibility of performing the assessments in a single-site and multi-site setting with a 70% threshold used to determine feasibility.
Measured: 2 years
Secondary outcomes (3)
To investigate the inter-observer variation (IOV) in tumour to background uptake measurements to assess reliability.
IOV in tumour to background uptake measurements
Measured: 2 years
To characterise dopamine uptake in high-grade glioma and low-grade glioma.
SUV/TBR corresponding to the optimal cut-off value for high-grade and low-grade glioma on receiver operating characteristic curve analysis.
Measured: 2 years
To provide data on the proportion of high-grade transformation in low-grade glioma.
Proportion of patients showing high-grade transformation following histopathology.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start1 Sep 2021
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by University 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK, University of Oxford
- Responsible party
- Sponsor
- Investigators
- Geoffrey Higgins, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870580
- Sponsor's protocol ID
- 127427
- Other IDs
- 272494
- Acronym
- FIG
- Status last verified
- Nov 2023
- First submitted
- 12 Apr 2021
- Last updated
- 18 Nov 2023
- 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 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [18F] FDOPA PET Imaging in Glioma: Feasibility Study for PET Guided Brain Biopsy
- ClinicalTrials.gov ID
- NCT04870580
- Acronym / sponsor ID
- FIG / 127427
- Conditions
- Glioma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Cancer Research UK, University of Oxford
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 3 May 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.
[18F]fluorodopa (3, 4-dihydroxy-6-[18F]fluoro-L-phenylalanine/ FDOPA) is an amino acid PET tracer originally developed for brain imaging in patients with movement disorders but has been found to be useful in brain tumour imaging. [18F]fluorodopa has been demonstrated to be predominantly transported by the L-type amino acid transporter without significant uptake into surrounding normal brain parenchyma with the exception of the basal ganglia. Assessing the feasibility of performing PET guided histopathology in a single and multi-site setting will be crucial in order to use PET as a planning tool for brain biopsy to detect high-grade transformation in low-grade gliomas.
Detailed description
Glioma is a cancer of unmet need, where survival trends have not significantly changed for decades. The distinction between high-grade (HGG) and low-grade glioma (LGG) is important as both entities confer different prognoses and management strategies. This distinction is normally made on biopsy sampling and conventional imaging. However, sampling errors are not uncommon due to the heterogeneous nature of glioma. Case series have described under-grading of gliomas on biopsy in 28% to 63% of cases. Furthermore, up to one third of high-grade gliomas may not display the typical imaging characteristics (enhancement) of a high-grade glioma. Therefore, more accurate imaging may help to make this distinction and guide biopsy and clinical management decisions at the outset.
There has been growing interest in the use of amino acid PET in glioma imaging. Transport of amino acids across the blood brain barrier and low physiological levels of tracer uptake within the brain allow for good tumour visualisation. The most frequently used amino acid PET tracers described in clinical literature are [11C]methionine, [18F]fluoroethyltyrosine and [18F]fluorodopa, which predominantly reflect leucine transport, being mainly transported by LAT1, a high affinity leucine transporter. Alongside depiction of tumour volume, described roles of amino acid PET include differentiation of true disease progression from pseudo progression, detection of residual disease in the post-surgical patient, biopsy guidance and prognostication.
Rationale The primary objective of the study will be to establish the feasibility of performing [18F]fluorodopa PET guided histopathology in a single and multi-site setting. Basic tumour characterisation (for example Ki67 expression and detection of IDH mutations) will be undertaken.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Other | Diagnostic Test: Fluorodopa PET tracerPET/CT with fluorodopa tracer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age over 18 years
- Diagnosed with low-grade glioma based on clinical standard of care imaging and scheduled for primary surgical resection of low-grade glioma
- Females of childbearing potential and males agree to use an effective method of contraception from the time consent is signed until 1 week after surgery.
- Females of childbearing potential have a negative urine pregnancy test within 7 days prior to being registered. Participants are considered not of child bearing potential if they are surgically sterile (i.e. they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal
- Willing and able to provide written informed consent
Key exclusion criteria (6 listed)
- Females who are pregnant, planning pregnancy or breastfeeding
- Concurrent and/or recent involvement in other research or use of another experimental investigational medicinal product that is likely to interfere with the study medication within 28 days of study enrolment.
- MRI contraindicated (e.g. implanted electric and electronic devices, heart pacemakers, insulin pumps, implanted hearing aids, neurostimulators, intracranial metal clips, metallic bodies in the eye).
- Other psychological, social or medical condition, physical examination finding or a laboratory abnormality that the Investigator considers would make the patient a poor study candidate or could interfere with protocol compliance or the interpretation of study results.
- Neoadjuvant chemotherapy/radiotherapy treatment for low-grade glioma which would interfere with the interpretation of study results.
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 |
|---|---|---|
| Fluorodopa PET tracerPET/CT scan using fluorodopa tracer | Diagnostic test | Intervention arm |
Primary outcome
To assess the feasibility of PET guided histopathology in a single and multi-site setting.
Time frame: 2 years
Assessment of tumour standardised uptake values (SUV) from [18F]fluorodopa PET with matched histopathology data from biopsies for evaluable patients from a single site and multiple sites. The percentage of cases where it is possible to collect this data will inform the feasibility of performing the assessments in a single-site and multi-site setting with a 70% threshold used to determine feasibility.
3 secondary outcomes
To investigate the inter-observer variation (IOV) in tumour to background uptake measurements to assess reliability.
Time frame: 2 years
To characterise dopamine uptake in high-grade glioma and low-grade glioma.
Time frame: 2 years
To provide data on the proportion of high-grade transformation in low-grade glioma.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- 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.
Geoffrey Higgins principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluorodopa PET tracer in people with Glioma, run by University 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 18 Nov 2023. 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?
Results are not available in the source record.
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?
To assess the feasibility of PET guided histopathology in a single and multi-site setting. (time frame: 2 years). 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 18 Nov 2023.