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

I

Institut Cancerologie de l'Ouest

Status

Enrolling

Conditions

MRI
Brain Metastases

Treatments

Radiation: F-DOPA PET/CT

Study type

Interventional

Funder types

Other

Identifiers

NCT04890028
ICO-2020-28

Details and patient eligibility

About

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).

Enrollment

52 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

52 participants in 1 patient group

F-DOPA PET/CT
Experimental group
Description:
Drug: 18 F-DOPA Radiation: F-DOPA PET CT
Treatment:
Radiation: F-DOPA PET/CT

Trial contacts and locations

3

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Central trial contact

Oliver MOREL, MD

Data sourced from clinicaltrials.gov

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