Detection and Metabolic Characterization in DOPA PET/CT of no Treated Brain Metastases of Lung Cancer, Breast Cancer and Melanoma
New PET Scan for Brain Metastases in Lung, Breast Cancer, and Melanoma
Plain English Summary
Detection and Metabolic Characterization in DOPA PET/CT of Brain Metastases is a Not Applicable clinical trial sponsored by Institut Cancerologie de l'Ouest studying Brain Metastases, MRI. This trial tests a new type of PET scan (DOPA PET/CT) to find brain tumors in patients with lung cancer, breast cancer, or melanoma. It is for patients who have been diagnosed with brain metastases (cancer that has spread to the brain) and have not yet received treatment for it. Participation involves having a special PET scan using a radioactive tracer called F-DOPA. The current standard for checking brain metastases is MRI, but this trial explores if the new PET scan can provide more detailed information. The trial aims to enroll 32 participants.
Official 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. 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).
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients with a confirmed diagnosis of lung cancer, breast cancer, or melanoma with at least one brain metastasis measuring 5mm or larger on MRI. Must be 18 years or older and have valid health insurance. Cannot have a history of radiation to the brain or brain surgery for metastases. Cannot have recently changed cancer treatments or started new ones before the PET scan. This trial is studying Brain Metastases, MRI, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures how well the new DOPA PET/CT scan can find brain metastases that are at least 5mm in size, meaning it assesses the scan's ability to accurately identify these tumors. The specific primary outcome measures are: 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. (Within 8 months of PET-CT). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial matters because it aims to improve the detection and understanding of brain metastases, which are common and serious in lung cancer, breast cancer, and melanoma, potentially leading to bett This research targets Brain Metastases, MRI, where improved treatment options are needed.
Investor Insight
This trial focuses on a specific diagnostic tool for a significant cancer complication, potentially impacting the market for advanced cancer imaging and diagnostics, with a moderate probability of inf
Is This Trial Right for Me?
Ask your doctor if this new PET scan is appropriate for your specific situation and how it compares to standard MRI. Participation involves undergoing the F-DOPA PET/CT scan, which includes an injection of the tracer. You will need to ensure your cancer treatments have not been recently changed before the scan. The trial is being conducted at 3 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 32 participants
Interventions
- RADIATION: F-DOPA PET/CT — All subjects will be imaged 1 time injection of 2 MBq/kg of 18F-DOPA
Primary Outcomes
- 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. (Within 8 months of PET-CT)
Secondary Outcomes
- Assess the sensitivity of 18F DOPA PET-CT according to the site of the primary tumor (lung cancer, breast cancer, melanoma) and its characteristics (Within 8 months of PET-CT)
Full Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
- CHU Angers, Angers, France
- Institut de Cancerologie de l'Ouest, Angers, France
- Institut de Cancerologie de L'Ouest, Saint-Herblain, France
Frequently Asked Questions
What is clinical trial NCT04890028?
NCT04890028 is a Not Applicable INTERVENTIONAL study titled "Detection and Metabolic Characterization in DOPA PET/CT of Brain Metastases." It is currently completed and is sponsored by Institut Cancerologie de l'Ouest. The trial targets enrollment of 32 participants.
What conditions does NCT04890028 study?
This trial investigates treatments for Brain Metastases, MRI. The primary condition under study is Brain Metastases.
What treatments are being tested in NCT04890028?
The interventions being studied include: F-DOPA PET/CT (RADIATION). All subjects will be imaged 1 time injection of 2 MBq/kg of 18F-DOPA
What does Not Applicable mean for NCT04890028?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT04890028?
This trial is currently "Completed." It started on 2021-12-03. The estimated completion date is 2026-02-15.
Who is sponsoring NCT04890028?
NCT04890028 is sponsored by Institut Cancerologie de l'Ouest. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT04890028?
The trial aims to enroll 32 participants. The trial status is completed.
How is NCT04890028 designed?
This is a interventional study, uses na allocation, follows a single_group design, employs none masking.
What are the primary outcomes being measured in NCT04890028?
The primary outcome measures are: 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. (Within 8 months of PET-CT). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT04890028 being conducted?
This trial is being conducted at 3 sites, including Angers; Saint-Herblain (France).
Where can I find official information about NCT04890028?
The official record for NCT04890028 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT04890028. This government database provides the most up-to-date and detailed information about the trial.
What is NCT04890028 testing in simple terms?
This trial tests a new type of PET scan (DOPA PET/CT) to find brain tumors in patients with lung cancer, breast cancer, or melanoma. It is for patients who have been diagnosed with brain metastases (cancer that has spread to the brain) and have not yet received treatment for it.
Why is this trial significant?
This trial matters because it aims to improve the detection and understanding of brain metastases, which are common and serious in lung cancer, breast cancer, and melanoma, potentially leading to bett
What are the potential risks of participating in NCT04890028?
The main risk is related to the injection of the radioactive tracer (F-DOPA), which is generally considered safe but can have mild side effects like nausea or headache. There is a small risk of allergic reaction to the tracer. The PET scan may not detect very small metastases (less than 5mm). As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT04890028?
Ask your doctor if this new PET scan is appropriate for your specific situation and how it compares to standard MRI. Participation involves undergoing the F-DOPA PET/CT scan, which includes an injection of the tracer. You will need to ensure your cancer treatments have not been recently changed before the scan. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT04890028 signal from an investment perspective?
This trial focuses on a specific diagnostic tool for a significant cancer complication, potentially impacting the market for advanced cancer imaging and diagnostics, with a moderate probability of inf This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves having a special PET scan using a radioactive tracer called F-DOPA. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.