PET/CT Whole-body Dynamic Acquisition at FDG to Metastatic Melanoma Under Immunotherapy

Study Purpose

The value of 4D body-to-whole dynamic acquisition in FDG PET / CT to differentiate progression / pseudo-progression during the first therapeutic assessment (PET1) of metastatic melanoma treated with immune checkpoint inhibitors (ICI)to predict the progression of the disease..

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patient old ≥ 18 years.
  • - With metastatic melanoma.
  • - Treated with anti-PD1 : Nivolumab or Pembrolizumab or Combo IPI-Nivo.
  • - Having formulated a non-opposition.

Exclusion Criteria:

  • - - Minor patient < 18 years.
  • - Pregnancy or breastfeeding.
  • - Other type of tumor than metastatic melanoma.
  • - Non-eligibility for the examination.
- Refusal of participation

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04272658
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital, Brest
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ronan ABGRAL, MD-PhD
Principal Investigator Affiliation Nuclear Medecine
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Metastatic Melanoma
Arms & Interventions

Arms

: value of 4D body-to-whole dynamic acquisition in FDG

differentiate pseudo-progression / progression during the first therapeutic assessment by FDG PET / CT (PET1) using data from the 4D whole-body dynamic acquisition, without having to re-evaluate closely. during a PET1 'this "unconfirmed progression" after 2 new treatment cures of immune checkpoint inhibitors in metastatic melanoma

Interventions

Diagnostic Test: - value of 4D body-to-whole dynamic acquisition in FDG

differentiate pseudo-progression / progression during the first therapeutic assessment by FDG PET / CT (PET1) using data from the 4D whole-body dynamic acquisition, without having to re-evaluate closely. during a PET1 'this "unconfirmed progression" after 2 new treatment cures of ICI

Contact a Trial Team

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International Sites

Hospital University ff Brest, Brest, Finistere, France

Status

Recruiting

Address

Hospital University ff Brest

Brest, Finistere, 29200

Site Contact

Ronan ABGRAL, MD-PhD

[email protected]

+33 (0) 298223327

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