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

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ClinicalTrials.gov Identifier: NCT03741231
Recruitment Status : Completed
First Posted : November 14, 2018
Last Update Posted : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

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

Condition or disease
Melanoma NSCLC Positron-Emission Tomography Immunotherapy 18F-FDG

Detailed Description:

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

Multicentric retrospective study


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Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 18FluoroDeoxyGlucose-Positron Emission Tomography (PET) in Patients With Melanoma or Non Small Cell Lung Cancer Treated With Immunotherapy
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
70 patients (50 patients with melanoma and 20 patients with NSCLC)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741231


Locations
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France
CHRU de Brest
Brest, France, 29609
CH de LANDERNEAU
Landerneau, France
Centre Hospitalier de Morlaix
Morlaix, France
Sponsors and Collaborators
University Hospital, Brest

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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03741231     History of Changes
Other Study ID Numbers: IMMUNOPET ( 29BRC17.0253).
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Brest:
melanoma
NSCLC
FDG
PET
immunotherapy

Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas