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

NCT ID: NCT04272658

Last Updated: 2024-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-26

Study Completion Date

2026-06-26

Brief Summary

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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..

Detailed Description

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Conditions

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Metastatic Melanoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

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

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ronan ABGRAL, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

Nuclear Medecine

Locations

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Hospital University ff Brest

Brest, Finistere, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Ronan ABGRAL, MD-PhD

Role: CONTACT

+33 (0) 298223327

Karim AMRANE, MD

Role: CONTACT

Facility Contacts

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Ronan ABGRAL, MD-PhD

Role: primary

Other Identifiers

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29BRC19.0194 (IMMUNO-PET2)

Identifier Type: -

Identifier Source: org_study_id

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