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

NCT ID: NCT04890028

Last Updated: 2025-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-03

Study Completion Date

2026-02-28

Brief Summary

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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).

Detailed Description

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Conditions

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Brain Metastases MRI

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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F-DOPA PET/CT

Drug: 18 F-DOPA Radiation: F-DOPA PET CT

Group Type EXPERIMENTAL

F-DOPA PET/CT

Intervention Type RADIATION

All subjects will be imaged

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

Interventions

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F-DOPA PET/CT

All subjects will be imaged

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

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Cancerologie de l'Ouest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Oliver Morel, MD

Role: PRINCIPAL_INVESTIGATOR

Institut de Cancérologie de l'Ouest

Locations

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CHU Angers

Angers, , France

Site Status RECRUITING

Institut de Cancerologie de l'Ouest

Angers, , France

Site Status RECRUITING

Institut de Cancerologie de L'Ouest

Saint-Herblain, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Oliver MOREL, MD

Role: CONTACT

241352700 ext. +33

Facility Contacts

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Pacôme FOSSE, MD

Role: primary

Olivier MOREL, MD

Role: primary

Paul LALIRE, MD

Role: primary

Marine TIGREAT

Role: backup

Other Identifiers

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ICO-2020-28

Identifier Type: -

Identifier Source: org_study_id

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