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

Primary Purpose

Brain Metastases, MRI

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
F-DOPA PET/CT
Sponsored by
Institut Cancerologie de l'Ouest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Metastases focused on measuring Breast cancer, Lung Cancer, Melanoma, DOPA PET/CT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • CHU AngersRecruiting
  • Institut de Cancerologie de l'OuestRecruiting
  • Institut de Cancerologie de L'OuestRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

F-DOPA PET/CT

Arm Description

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

Outcomes

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.
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
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)

Full Information

First Posted
May 12, 2021
Last Updated
July 31, 2023
Sponsor
Institut Cancerologie de l'Ouest
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1. Study Identification

Unique Protocol Identification Number
NCT04890028
Brief Title
Detection and Metabolic Characterization in DOPA PET/CT of Brain Metastases
Acronym
DOPACER
Official Title
Detection and Metabolic Characterization in DOPA PET/CT of no Treated Brain Metastases of Lung Cancer, Breast Cancer and Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 3, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Cancerologie de l'Ouest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastases, MRI
Keywords
Breast cancer, Lung Cancer, Melanoma, DOPA PET/CT

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
F-DOPA PET/CT
Arm Type
Experimental
Arm Description
Drug: 18 F-DOPA Radiation: F-DOPA PET CT
Intervention Type
Radiation
Intervention Name(s)
F-DOPA PET/CT
Intervention Description
All subjects will be imaged 1 time injection of 2 MBq/kg of 18F-DOPA
Primary Outcome Measure Information:
Title
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.
Description
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
Time Frame
Within 8 months of PET-CT
Secondary Outcome Measure Information:
Title
Assess the sensitivity of 18F DOPA PET-CT according to the site of the primary tumor (lung cancer, breast cancer, melanoma) and its characteristics
Description
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)
Time Frame
Within 8 months of PET-CT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oliver MOREL, MD
Phone
241352700
Ext
+33
Email
olivier.morel@ico.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Morel, MD
Organizational Affiliation
Institut de Cancérologie de l'Ouest
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49055
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pacôme FOSSE, MD
Email
pafosse@chu-angers.fr
Facility Name
Institut de Cancerologie de l'Ouest
City
Angers
ZIP/Postal Code
49055
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier MOREL, MD
Email
olivier.morel@ico.unicancer.fr
Facility Name
Institut de Cancerologie de L'Ouest
City
Saint-Herblain
ZIP/Postal Code
44055
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul LALIRE, MD
Email
paul.lalire@ico.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Marine TIGREAT
Email
marine.tigreat@ico.unicancer.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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

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