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

Sponsor

Institut Cancerologie de l'Ouest (Other)

Overall Status

Recruiting

CT.gov ID

NCT04890028

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Dec 3, 2021

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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]
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

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]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Angers	Angers		France	49055
2	Institut de Cancerologie de l'Ouest	Angers		France	49055

Sponsors and Collaborators

Institut Cancerologie de l'Ouest

Investigators

Principal Investigator: Oliver Morel, MD, Institut de Cancérologie de l'Ouest

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institut Cancerologie de l'Ouest

ClinicalTrials.gov Identifier:

NCT04890028

Other Study ID Numbers:

ICO-2020-28

First Posted:

May 18, 2021

Last Update Posted:

Jan 14, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Institut Cancerologie de l'Ouest

Additional relevant MeSH terms:

Neoplasm Metastasis

Brain Neoplasms

Study Results

No Results Posted as of Jan 14, 2022