Brain TumorFDOPANCT04306484
18F-DOPA-PET in Non-tumoral and Tumoral Brain Lesions
An observational study of Brain Tumor, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Background: 3,4-dihydroxy-6-[18F]-fluoro-L-phenylalanine (FDOPA) positron emission tomography (PET) can identify well low and high grade brain tumors. However, increased FDOPA uptake has been reported in non-tumoral brain lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor
- What is being tested?
- FDOPA-TEP
- Type of treatment
- Injection or infusion
- How many people
- 74 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 31 Dec 2020
- 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 suspected primary brain tumor (based on clinical and MRI findings) referred for FDOPA-PET in our centre between June 2015 and June 2019
Who may be able to join
- presence of defined tumor (histology was required) or non-tumor (diagnosed by histological or other analyses) diagnosis,
- clinical and MRI follow-up of >24 months,
- FDOPA-PET scan <2 months before surgery or stereotactic biopsy (when performed)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Background: 3,4-dihydroxy-6-[18F]-fluoro-L-phenylalanine (FDOPA) positron emission tomography (PET) can identify well low and high grade brain tumors. However, increased FDOPA uptake has been reported in non-tumoral brain lesions. The aim was to analyse FDOPA-PET in patients with non-tumoral brain lesions and to compare them with patients with (low and high grade) brain tumors.
Methods: retrospective analyse. Patients consecutively recruited with suspected primary brain tumor (based on clinical and MRI findings) referred for FDOPA-PET at Nimes university Hospital between June 2015 and June 2019. FDOPA-PET parameters (maximum and mean lesion standardized uptake values [SUV] and ratios comparing lesion with different background uptake SUV) and thresholds were analysed in search for those offering optimal discrimination between non-tumoral and tumoral lesions.
- Conditions
- Brain Tumor
- Being tested
- FDOPA-TEP
- Keywords
- tumor, tumoral, non-tumoral, pseudotumoral, 3,4-dihydroxy-6-[18F]-fluoro-L-phenylalanine, FDOPA, positron emission tomography, PET
- Medical subject headings
- Brain Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDOPA-TEPDiagnostic test
FDOPA-TEP performed as part of the normal management of a suspected brain tumour
| Study group | Role | What they receive |
|---|---|---|
| patients with tumoral brain lesion | The 48 tumor patients included 8 low grade (grade II glioma, n=7; grade II ependymoma, n=1), and 40 high grade (grade III glioma, n=12; grade IV glioma, n=25, primary cerebral lymphoma, n=1; medulloblastoma, n=1, and metastatic cerebral breast cancer, n=1) tumors. Histology was available for all tumor patients. Receives: Diagnostic Test: FDOPA-TEP | |
| patients with non-tumoral brain lesion | The non-tumor group included patients with an inflammatory lesion (n=11), lobar primary intracerebral haemorrhage (n=3), cortical dysplasia (n=3), infectious lesion (n=2, both toxoplasmosis), cerebral cavernomatous malformation (n=1), seronegative autoimmune limbic encephalitis (n=1), deep venous sinus thrombosis-related oedema (n=1), brain infarction (n=1), chronic posttraumatic brain lesion (n=1), radionecrosis after radiation therapy for arteriovenous malformation (n=1), and mixed inflammatory/infectious lesion (n=1, multiple sclerosis lesion complicated by biopsy-related infection). Receives: Diagnostic Test: FDOPA-TEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
FDOPA-TEP
analyse of FDOPA-PET parameters (maximum and mean lesion standardized uptake values [SUV] and ratios comparing lesion with different background uptake SUV)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start1 Jan 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Retrospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306484
- Sponsor's protocol ID
- LOCAL/2020/DR-01
- Acronym
- FDOPA
- Status last verified
- Mar 2020
- First submitted
- 10 Mar 2020
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Renard D, Collombier L, Laurent-Chabalier S, Mura T, Le Floch A, Fertit HE, Thouvenot E, Guillamo JS. 18F-FDOPA-PET in pseudotumoral brain lesions. J Neurol. 2021 Apr;268(4):1266-1275. doi: 10.1007/s00415-020-10269-9. Epub 2020 Oct 21.
PubMed 33084938
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-DOPA-PET in Non-tumoral and Tumoral Brain Lesions
- ClinicalTrials.gov ID
- NCT04306484
- Acronym / sponsor ID
- FDOPA / LOCAL/2020/DR-01
- Conditions
- Brain Tumor
- Keywords
- tumor, tumoral, non-tumoral, pseudotumoral, 3,4-dihydroxy-6-[18F]-fluoro-L-phenylalanine, FDOPA, positron emission tomography, PET
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 13 Mar 2020 (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.
Background: 3,4-dihydroxy-6-[18F]-fluoro-L-phenylalanine (FDOPA) positron emission tomography (PET) can identify well low and high grade brain tumors. However, increased FDOPA uptake has been reported in non-tumoral brain lesions. The aim was to analyse FDOPA-PET in patients with non-tumoral brain lesions and to compare them with patients with (low and high grade) brain tumors.
Methods: retrospective analyse. Patients consecutively recruited with suspected primary brain tumor (based on clinical and MRI findings) referred for FDOPA-PET at Nimes university Hospital between June 2015 and June 2019. FDOPA-PET parameters (maximum and mean lesion standardized uptake values [SUV] and ratios comparing lesion with different background uptake SUV) and thresholds were analysed in search for those offering optimal discrimination between non-tumoral and tumoral lesions.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with tumoral brain lesion | – | Diagnostic Test: FDOPA-TEPThe 48 tumor patients included 8 low grade (grade II glioma, n=7; grade II ependymoma, n=1), and 40 high grade (grade III glioma, n=12; grade IV glioma, n=25, primary cerebral lymphoma, n=1; medulloblastoma, n=1, and metastatic cerebral breast cancer, n=1) tumors. Histology was available for all tumor patients. |
| patients with non-tumoral brain lesion | – | Diagnostic Test: FDOPA-TEPThe non-tumor group included patients with an inflammatory lesion (n=11), lobar primary intracerebral haemorrhage (n=3), cortical dysplasia (n=3), infectious lesion (n=2, both toxoplasmosis), cerebral cavernomatous malformation (n=1), seronegative autoimmune limbic encephalitis (n=1), deep venous sinus thrombosis-related oedema (n=1), brain infarction (n=1), chronic posttraumatic brain lesion (n=1), radionecrosis after radiation therapy for arteriovenous malformation (n=1), and mixed inflammatory/infectious lesion (n=1, multiple sclerosis lesion complicated by biopsy-related infection). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with suspected primary brain tumor (based on clinical and MRI findings) referred for FDOPA-PET in our centre between June 2015 and June 2019
Key inclusion criteria (3 listed)
- presence of defined tumor (histology was required) or non-tumor (diagnosed by histological or other analyses) diagnosis,
- clinical and MRI follow-up of >24 months,
- FDOPA-PET scan <2 months before surgery or stereotactic biopsy (when performed)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| FDOPA-TEPFDOPA-TEP performed as part of the normal management of a suspected brain tumour | Diagnostic test | patients with non-tumoral brain lesion, patients with tumoral brain lesion |
Primary outcome
FDOPA-TEP
Time frame: Day 1
analyse of FDOPA-PET parameters (maximum and mean lesion standardized uptake values [SUV] and ratios comparing lesion with different background uptake SUV)
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 4 Dec 2025.
- Results publication: PubMed 33084938Renard D, Collombier L, Laurent-Chabalier S, Mura T, Le Floch A, Fertit HE, Thouvenot E, Guillamo JS. 18F-FDOPA-PET in pseudotumoral brain lesions. J Neurol. 2021 Apr;268(4):1266-1275. doi: 10.1007/s00415-020-10269-9. Epub 2020 Oct 21.
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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 Brain Tumor, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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 3 inclusion and 0 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 4 Dec 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 France. 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?
FDOPA-TEP (time frame: Day 1). 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 NCT04306484, 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 4 Dec 2025.