MelanomaIMMUNOPETNCT03741231
18FDG-PET in Patients With Melanoma or NSCLC Treated With Immunotherapy
An observational study of Melanoma and NSCLC, run by University Hospital, Brest at 3 sites in France.
Trial summary
Study the EFS and OS according to 18FDG PET in patients with melanoma or non small cell lung cancer treated by immunotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, NSCLC, Positron-Emission Tomography
- How many people
- 70 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Mar 2018to 30 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 70 patients (50 patients with melanoma and 20 patients with NSCLC)
Who may be able to join
- 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
Who cannot join
- age under 18 years old
- refusal to participate
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHRU de Brest
Brest, 29609
CH de LANDERNEAU
Landerneau
Centre Hospitalier de Morlaix
Morlaix
About this study
Official title: 18FluoroDeoxyGlucose-Positron Emission Tomography (PET) in Patients With Melanoma or Non Small Cell Lung Cancer 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.
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
- Conditions
- Melanoma, NSCLC, Positron-Emission Tomography, Immunotherapy, 18F-FDG
- Keywords
- melanoma, NSCLC, FDG, PET, immunotherapy
- Medical subject headings
- Melanoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 50 months
Secondary outcomes (3)
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.
Measured: up to 50 months
Study different criteria (RECIST, iRECIST, PERCIST and PECRIT) to predict PFS or OS
Interpretation according to 4 criteria to predict response to immunotherapy
Measured: up to 50 months
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
Measured: up to 50 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start1 Mar 2018
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03741231
- Sponsor's protocol ID
- IMMUNOPET ( 29BRC17.0253).
- Acronym
- IMMUNOPET
- Status last verified
- Mar 2019
- First submitted
- 13 Jul 2018
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18FluoroDeoxyGlucose-Positron Emission Tomography (PET) in Patients With Melanoma or Non Small Cell Lung Cancer Treated With Immunotherapy
- ClinicalTrials.gov ID
- NCT03741231
- Acronym / sponsor ID
- IMMUNOPET / IMMUNOPET ( 29BRC17.0253).
- Conditions
- Melanoma, NSCLC, Positron-Emission Tomography, Immunotherapy, 18F-FDG
- Keywords
- melanoma, NSCLC, FDG, PET, immunotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 14 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study the EFS and OS according to 18FDG PET in patients with melanoma or non small cell lung cancer treated by immunotherapy.
Detailed description
Study EFS in patients with melanoma or NSCLC treated by immunotherapy (anti CTLA4 or anti PDL1) and performed18FDG PET
Multicentric retrospective study
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 70 patients (50 patients with melanoma and 20 patients with NSCLC)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- age under 18 years old
- refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
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
Study different criteria (RECIST, iRECIST, PERCIST and PECRIT) to predict PFS or OS
Time frame: up to 50 months
study the potential correlation between PET data and clinicobiological data
Time frame: up to 50 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma and NSCLC, run by University Hospital, Brest at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2019.