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

NCT04890028 | Completed

• 1 other identifier: ICO-2020-28
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

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).

Conditions

Brain Metastases; MRI

Keywords

Breast cancer; Lung Cancer; Melanoma; DOPA PET/CT

Outcome Measures

Primary Outcomes (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.

  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

  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

  Within 8 months of PET-CT

Study Arms (1)

F-DOPA PET/CT

EXPERIMENTAL

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

Radiation: F-DOPA PET/CT

Interventions

F-DOPA PET/CT RADIATION

All subjects will be imaged 1 time injection of 2 MBq/kg of 18F-DOPA

F-DOPA PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (3)

CHU Angers

Angers, 49055, France

Location

Institut de Cancerologie de l'Ouest

Angers, 49055, France

Location

Institut de Cancerologie de L'Ouest

Saint-Herblain, 44055, France

Location

MeSH Terms

Conditions

Brain Neoplasms; Breast Neoplasms; Lung Neoplasms; Melanoma

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms

Study Officials

• Oliver Morel, MD

  Institut de Cancérologie de l'Ouest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 18, 2021
• Study Start: December 3, 2021
• Primary Completion: December 3, 2025
• Study Completion: February 15, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)