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Completed

NCT Number: NCT03741231

18FDG-PET in Patients With Melanoma or NSCLC Treated With Immunotherapy

Study the EFS and OS according to 18FDG PET in patients with melanoma or non small cell lung cancer treated by immunotherapy.

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Key information

Conditions

Melanoma 18F-FDG Immunotherapy NSCLC Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Positron-Emission Tomography Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Brest, Brest, France

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About this study

Study EFS in patients with melanoma or NSCLC treated by immunotherapy (anti CTLA4 or anti PDL1) and performed18FDG PET

Multicentric retrospective study

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients treated for melanoma or NSCLC with immunotherapy (anti CTLA4 or antiPDL1)
  • patients treated in Brest, Morlaix, Landerneau hospital
  • patients performed FDG PET
  • no opposition to study

Exclusion criteria

  • age under 18 years old
  • refusal to participate

Treatment and study plan

Primary outcomes

  1. measure of progression free survival (obtained by the delay between the date of initiation of immunotherapy until the date of first documented progression disease in patients with melanoma or NSCLC treated by immunotherapy

    Time frame: up to 50 months

    From date of initiation of treatment until the date of first documented progression disease according to different criteria in interim PET/CT 1.

    18F-FDG PET/CT imaging was performed prior to (18F-FDG PET/CT 0) and 14 weeks after ICI onset (18F-FDG PET/CT 1). Assessment of patient response to treatment was done according to RECIST1.1, iRECIST, PERCIST and PECRIT criteria.

Secondary outcomes

  1. measure of overall survival (obtained by the delay between the date of initiation of immunotherapy until the date of death related to disease in patients with melanoma or NSCLC treated by immunotherapy

    Time frame: up to 50 months

    From date of initiation of treatment until the date of death related to disease according to different criteria in interim PET/CT 1.

    18F-FDG PET/CT imaging was performed prior to (18F-FDG PET/CT 0) and 14 weeks after ICI onset (18F-FDG PET/CT 1). Assessment of patient response to treatment was done according to RECIST1.1, iRECIST, PERCIST and PECRIT criteria.

  2. Study different criteria (RECIST, iRECIST, PERCIST and PECRIT) to predict PFS or OS

    Time frame: up to 50 months

    Interpretation according to 4 criteria to predict response to immunotherapy

  3. study the potential correlation between PET data and clinicobiological data

    Time frame: up to 50 months

    correlation between adverse events (AE) due to immunotherapy described on PET data and AE detected on clinicobiological data

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

18FluoroDeoxyGlucose-Positron Emission Tomography (PET) in Patients With Melanoma or Non Small Cell Lung Cancer Treated With Immunotherapy

Acronym: IMMUNOPET

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 14, 2018
Registry last updated
May 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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