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CompletedNCT03741231IMMUNOPETUpdated May 6, 2019

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

An observational study in Melanoma, NSCLC and Positron-Emission Tomography, sponsored by University Hospital, Brest. Completed at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-06.

Sponsored by University Hospital, Brest · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
70
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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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Conditions studied

  • Melanoma
  • NSCLC
  • Positron-Emission Tomography
  • Immunotherapy
  • 18F-FDG

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Keywords

  • melanoma
  • NSCLC
  • FDG
  • PET
  • immunotherapy
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In context

Melanoma

3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.

This study's enrollment of 70 is below the median of 182 across 438 observational studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

University Hospital, Brest is the lead sponsor of 594 studies on the registry; 135 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

70 patients (50 patients with melanoma and 20 patients with NSCLC)

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

Exclusion Criteria:

  • age under 18 years old
  • refusal to participate
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
70 participants (actual)
Patient registry
No
06

What researchers measure

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

    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.

    Time frame: up to 50 months

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

    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.

    Time frame: up to 50 months

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

    Interpretation according to 4 criteria to predict response to immunotherapy

    Time frame: up to 50 months

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

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

    Time frame: up to 50 months

07

Study locations

3 sites
  • CHRU de Brest
    Brest, 29609, France
  • CH de LANDERNEAU
    Landerneau, France
  • Centre Hospitalier de Morlaix
    Morlaix, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03741231
Lead sponsor
University Hospital, Brest
Responsible party
Sponsor
First posted
Nov 14, 2018
Start date
Mar 1, 2018
Primary completion
Jun 30, 2018
Completion
Jun 30, 2018
Last update
May 6, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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