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

Brain Metastases Clinical Trial

— DOPACER  

Official title:

Detection and Metabolic Characterization in DOPA PET/CT of no Treated Brain Metastases of Lung Cancer, Breast Cancer and Melanoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04890028
• Other study ID #: ICO-2020-28
• Status: Recruiting
• Phase: N/A
• Start date: December 3, 2021
• Est. completion date: February 2024

Study information

• Verified date: April 2023
• Source: Institut Cancerologie de l'Ouest
• Contact: Oliver MOREL, MD
• Phone: 241352700
• Email: olivier.morel[@]ico.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: February 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• MRI
• Neoplasm Metastasis

Intervention

Radiation:
• F-DOPA PET/CT
All subjects will be imaged 1 time injection of 2 MBq/kg of 18F-DOPA

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	Institut de Cancerologie de l'Ouest	Angers
France	Institut de Cancerologie de L'Ouest	Saint-Herblain

Sponsors (1)

Lead Sponsor	Collaborator
Institut Cancerologie de l'Ouest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	Within 8 months of PET-CT