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Detection and Metabolic Characterization in DOPA PET/CT of Brain Metastases (DOPACER)

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ClinicalTrials.gov Identifier: NCT04890028
Recruitment Status : Recruiting
First Posted : May 18, 2021
Last Update Posted : January 14, 2022
Sponsor:
Information provided by (Responsible Party):
Institut Cancerologie de l'Ouest

Brief 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).


Condition or disease Intervention/treatment Phase
Brain Metastases MRI Radiation: F-DOPA PET/CT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Detection and Metabolic Characterization in DOPA PET/CT of no Treated Brain Metastases of Lung Cancer, Breast Cancer and Melanoma
Actual Study Start Date : December 3, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: F-DOPA PET/CT
Drug: 18 F-DOPA Radiation: F-DOPA PET CT
Radiation: F-DOPA PET/CT

All subjects will be imaged

1 time injection of 2 MBq/kg of 18F-DOPA





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  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 [ Time Frame: Within 8 months of PET-CT ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04890028


Contacts
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Contact: Oliver MOREL, MD 241352700 ext +33 olivier.morel@ico.unicancer.fr

Locations
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France
CHU Angers Recruiting
Angers, France, 49055
Contact: Pacôme FOSSE, MD       pafosse@chu-angers.fr   
Institut de Cancerologie de l'Ouest Recruiting
Angers, France, 49055
Contact: Olivier MOREL, MD       olivier.morel@ico.unicancer.fr   
Sponsors and Collaborators
Institut Cancerologie de l'Ouest
Investigators
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Principal Investigator: Oliver Morel, MD Institut de Cancérologie de l'Ouest
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Responsible Party: Institut Cancerologie de l'Ouest
ClinicalTrials.gov Identifier: NCT04890028    
Other Study ID Numbers: ICO-2020-28
First Posted: May 18, 2021    Key Record Dates
Last Update Posted: January 14, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Cancerologie de l'Ouest:
Breast cancer
Lung Cancer
Melanoma
DOPA PET/CT
Additional relevant MeSH terms:
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Neoplasm Metastasis
Brain Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases