Clinical trial NCT04890028: Detection and Metabolic Characterization in DOPA PET/CT of Brain Metastases
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
Overall status: UNKNOWN
Phase: NA
Conditions: Brain Metastases
MRI
Keywords: Breast cancer
Lung Cancer
Melanoma
DOPA PET/CT
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).


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.

Primary outcomes:
measure: 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.
timeFrame: Within 8 months of PET-CT
Secondary outcomes:
measure: Assess the sensitivity of 18F DOPA PET-CT according to the site of the primary tumor (lung cancer, breast cancer, melanoma) and its characteristics
timeFrame: Within 8 months of PET-CT
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Angers
country: France
facility: Institut de Cancerologie de l'Ouest
city: Saint-Herblain
country: France
facility: Institut de Cancerologie de L'Ouest
Study officials:
affiliation: Institut de Cancérologie de l'Ouest
name: Oliver Morel, MD
role: PRINCIPAL_INVESTIGATOR
References: