Brain MetastasesDOPACERNCT04890028
Detection and Metabolic Characterization in DOPA PET/CT of Brain Metastases
A study testing F-DOPA PET/CT in people with Brain Metastases and MRI, run by Institut Cancerologie de l'Ouest at 3 sites in France.
Trial summary
About 20 to 30% of patients treated for cancer will have brain metastases. These brain metastases are found more frequently in patients with lung cancer, breast cancer or melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases, MRI
- What is being tested?
- F-DOPA PET/CT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesFrance
- Study dates
- 3 Dec 2021to 15 Feb 2026
- 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
- Primitive cancer (brest cancer, lung cancer, melanoma) proven histologically
- Presence of brain metastasis visualized on MRI, of which at least one measures 5 mm
- Age > 18 years
- Patient has valid health insurance
- Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations
Who cannot join
- History of irradiation cerebral
- History of brain surgery for brain metastasis or glial tumor
- Systemic therapy (chemotherapy, targeted therapy, immunotherapy) modified in the 6 weeks preceding the realization of DOPA PET/CT,
- New anti-tumor treatment started between the discovery of brain metastases and the performance of DOPA PET/CT
- Other concomitant cancer, or history of cancer in the 5 years preceding the performance of DOPA PET/CT
- Pregnant or lactating females
- Persons deprived of their liberty, under a measure of safeguard of justice, under guardianship or placed under the authority of a guardian.
- Disorder precluding understanding of trial information or informed consent.
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU Angers
Angers, 49055
Institut de Cancerologie de l'Ouest
Angers, 49055
Institut de Cancerologie de L'Ouest
Saint-Herblain, 44055
About this study
Official title: Detection and Metabolic Characterization in DOPA PET/CT of no Treated Brain Metastases of Lung Cancer, Breast Cancer and Melanoma
About 20 to 30% of patients treated for cancer will have brain metastases. These brain metastases are found more frequently in patients with lung cancer, breast cancer or melanoma. The prognosis of these patients is unfavorable but prolonged survival can be obtained with the local and systemic treatments currently available.
Brain MRI is the gold standard for evaluating brain metastases but has limitations in therapeutic evaluation, partially offset by PET imaging of amino acid metabolism.
Our work aims to compare the performance of PET-DOPA with standard MRI for the detection of brain metastases (≥ 5mm) in lung cancer, breast cancer and melanoma; and to characterize these lesions using dynamic acquisitions obtained with a digital PET camera with high spatial resolution. Having better knowledge of the metabolic characteristics of newly discovered brain metastases, the objective of subsequent studies will be to better assess the per- or post-therapeutic efficacy of radiotherapy and the various systemic therapies available (chemotherapy, targeted therapy, immunotherapy).
- Conditions
- Brain Metastases, MRI
- Being tested
- F-DOPA PET/CT
- Keywords
- Breast cancer, Lung Cancer, Melanoma, DOPA PET/CT
- Medical subject headings
- Brain Neoplasms, Breast Neoplasms, Lung Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F-DOPA PET/CTRadiation
All subjects will be imaged
1 time injection of 2 MBq/kg of 18F-DOPA
| Study group | Role | What they receive |
|---|---|---|
| F-DOPA PET/CT | Experimental | Drug: 18 F-DOPA Radiation: F-DOPA PET CT Receives: Radiation: F-DOPA PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the sensitivity of 18F DOPA PET-CT for the detection of no treated brain metastases (breast cancer, lung cancer, melanoma), newly diagnosed by MRI and measuring at least 5 mm in diameter.
The sensitivity of PET-DOPA to detect brain metastases greater than 5 mm is determined by the number of metastases detected with PET-DOPA compared to the number of metastases greater than 5 mm detected by MRI
Measured: Within 8 months of PET-CT
Secondary outcomes (1)
Assess the sensitivity of 18F DOPA PET-CT according to the site of the primary tumor (lung cancer, breast cancer, melanoma) and its characteristics
The sensitivity per site will be calculated for 8 primary tumor categories: 3 for lung cancer (EGFR mutation or ALK rearrangement; PDL1 +; others), 2 for melanoma (BRAF V600 mutation; others), 3 for breast cancer (triple negative; Her2 + RH-; others)
Measured: Within 8 months of PET-CT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start3 Dec 2021
- Primary completion3 Dec 2025
- Study completion15 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oliver Morel, MD, Principal investigator, Institut de Cancérologie de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890028
- Sponsor's protocol ID
- ICO-2020-28
- Acronym
- DOPACER
- Status last verified
- Mar 2026
- First submitted
- 12 May 2021
- Last updated
- 31 Mar 2026
- 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 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection and Metabolic Characterization in DOPA PET/CT of no Treated Brain Metastases of Lung Cancer, Breast Cancer and Melanoma
- ClinicalTrials.gov ID
- NCT04890028
- Acronym / sponsor ID
- DOPACER / ICO-2020-28
- Conditions
- Brain Metastases, MRI
- Keywords
- Breast cancer, Lung Cancer, Melanoma, DOPA PET/CT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 3 Dec 2021 (actual)
- Primary completion
- 3 Dec 2025 (actual)
- Study completion
- 15 Feb 2026 (actual)
- First posted
- 18 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.
About 20 to 30% of patients treated for cancer will have brain metastases. These brain metastases are found more frequently in patients with lung cancer, breast cancer or melanoma. The prognosis of these patients is unfavorable but prolonged survival can be obtained with the local and systemic treatments currently available.
Brain MRI is the gold standard for evaluating brain metastases but has limitations in therapeutic evaluation, partially offset by PET imaging of amino acid metabolism.
Our work aims to compare the performance of PET-DOPA with standard MRI for the detection of brain metastases (≥ 5mm) in lung cancer, breast cancer and melanoma; and to characterize these lesions using dynamic acquisitions obtained with a digital PET camera with high spatial resolution. Having better knowledge of the metabolic characteristics of newly discovered brain metastases, the objective of subsequent studies will be to better assess the per- or post-therapeutic efficacy of radiotherapy and the various systemic therapies available (chemotherapy, targeted therapy, immunotherapy).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| F-DOPA PET/CT | Experimental | Radiation: F-DOPA PET/CTDrug: 18 F-DOPA Radiation: F-DOPA PET CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primitive cancer (brest cancer, lung cancer, melanoma) proven histologically
- Presence of brain metastasis visualized on MRI, of which at least one measures 5 mm
- Age > 18 years
- Patient has valid health insurance
- Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations
Key exclusion criteria (8 listed)
- History of irradiation cerebral
- History of brain surgery for brain metastasis or glial tumor
- Systemic therapy (chemotherapy, targeted therapy, immunotherapy) modified in the 6 weeks preceding the realization of DOPA PET/CT,
- New anti-tumor treatment started between the discovery of brain metastases and the performance of DOPA PET/CT
- Other concomitant cancer, or history of cancer in the 5 years preceding the performance of DOPA PET/CT
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 |
|---|---|---|
| F-DOPA PET/CTAll subjects will be imaged 1 time injection of 2 MBq/kg of 18F-DOPA | Radiation | F-DOPA PET/CT |
Primary outcome
Assess the sensitivity of 18F DOPA PET-CT for the detection of no treated brain metastases (breast cancer, lung cancer, melanoma), newly diagnosed by MRI and measuring at least 5 mm in diameter.
Time frame: Within 8 months of PET-CT
The sensitivity of PET-DOPA to detect brain metastases greater than 5 mm is determined by the number of metastases detected with PET-DOPA compared to the number of metastases greater than 5 mm detected by MRI
1 secondary outcome
Assess the sensitivity of 18F DOPA PET-CT according to the site of the primary tumor (lung cancer, breast cancer, melanoma) and its characteristics
Time frame: Within 8 months of PET-CT
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 31 Mar 2026.
- 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.
Oliver Morel, MD principal investigator
Institut de Cancérologie de l'Ouest
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing F-DOPA PET/CT in people with Brain Metastases and MRI, run by Institut Cancerologie de l'Ouest at 3 sites 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 5 inclusion and 8 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 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Assess the sensitivity of 18F DOPA PET-CT for the detection of no treated brain metastases (breast cancer, lung cancer, melanoma), newly diagnosed by MRI and measuring at least 5 mm in diameter. (time frame: Within 8 months of PET-CT). 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 31 Mar 2026.