Non-Small Cell Bronchopulmonary Carcinoma or MelanomaFDG-IMMUNNCT03584334
18FDG PET for Early Identification of Tumor Exhaust for Immunotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Bronchopulmonary Carcinoma or Melanoma
A study testing 18FDG PET in people with Non-Small Cell Bronchopulmonary Carcinoma or Melanoma, run by Centre Antoine Lacassagne at 1 site in France.
Trial summary
The hypothesis of this diagnostic performance study is that, for patients treated for immunotherapy-treated melanoma or NSCLC, some metabolic parameters of the 18FDG dual-point PET scan distinguish inflammatory pseudo-progression from tumor progression true and thus improve the evaluation of tumor response to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Bronchopulmonary Carcinoma or Melanoma
- What is being tested?
- 18FDG PET
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 4 Apr 2019to 26 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Age > or = 18 years,
- Patients with unresectable melanoma or histologically proven, metastatic or locally advanced NSCLC,
- Indication of an immunotherapy treatment with nivolumab or pembrolizumab validated in multidisciplinary consultation team and prescribed as part of their marketing authorization, in first or second line of treatment,
- Performance Status 0 to 2,
- Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required,
- Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 6 months after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year,
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- Male subjects should agree to use an adequate method of contraception or abstain from heterosexual activity starting with the first dose of study therapy through 6 months after the last dose of study therapy,
- Patient willing and able to provide written informed consent/assent for the trial,
- Patient affiliated with a health insurance system.
Who cannot join
- Age < 18 years,
- Contraindication to performing 18FDG PET scans: severe claustrophobia, unbalanced diabetes during PET examinations (fasting capillary blood glucose ≥ 11 mmol),
- Any participation in other biomedical studies related to the drug, medical devices or imaging techniques is prohibited except biomedical studies called overstudies (In case of doubt or questions about the patient's participation in a other clinical study, please contact the sponsor),
- Contraindication to nivolumab or pembrolizumab treatment,
- Patient with metastatic disease,
- History of thoracic irradiation or near / in the thoracic irradiation field,
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- Patient who refuses to participate in the study or unable to agree,
- Patient currently receiving one or more treatments described in section 6.9 of the protocol,
- Contraindication to nivolumab or pembrolizumab treatment,
- People particularly vulnerable as defined in Articles L.1121-5 to -8 of the French Healthcare Code, including: person deprived of freedom by an administrative or judicial decision, adult being the object of a legal protection measure or outside a state to express their consent, pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cohort Study Evaluating 18FDG PET for Early Identification of Tumor Exhaust for Immunotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Bronchopulmonary Carcinoma or Melanoma
The hypothesis of this diagnostic performance study is that, for patients treated for immunotherapy-treated melanoma or NSCLC, some metabolic parameters of the 18FDG dual-point PET scan distinguish inflammatory pseudo-progression from tumor progression true and thus improve the evaluation of tumor response to immunotherapy
Read the detailed description
The originality of this study is based on the stakes of the early prediction of resistance to immunotherapy (early therapeutic escapes, side effects, cost of treatment etc.).
No prospective study has been published to date on the value of 18FDG PET to distinguish between true tumor progression and pseudo-progression. Studies are therefore needed to define new criteria for evaluating the metabolic response specific to immunotherapy, as well as the optimal timing of the interim examination.
The goal is to conduct a transversal, non-randomized, prospective, multi-center, diagnostic performance study, harmonizing the moments of the 18FDG PET scans, acquisition conditions and interpretation criteria. The use of a dual-point acquisition in PET will also make it possible to judge the kinetics of 18FDG lesion capture (calculation of the 18FDG retention index on the late image) with the objective of highlighting PET criteria to distinguish between inflammatory pseudo-progression and true tumor progression in patients with unresectable melanoma or advanced or metastatic NSCLC. Other metabolic parameters will be studied, such as changes in tumor metabolic volume and binding intensities.
Finally, this study will include patients to assess the correlation between the metabolic tumor response observed after 7 weeks of immunotherapy, the morphological response after 3 months of treatment (RECIST v1.1 and i-RECIST) and survival overall at 1 year.
- Being tested
- 18FDG PET
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18FDG PETRadiation
Diagnostic performance of 18FDG PET for identification of early tumor escape to immunotherapy in patients with unresectable melanoma or Broncho-Pulmonary Carcinoma No to Advanced or Metastatic Small Cells
| Study group | Role | What they receive |
|---|---|---|
| 18FDG PET | Other | Diagnostic performance of 18FDG PET for identification of early tumor escape to immunotherapy in patients with unresectable melanoma or Broncho-Pulmonary Carcinoma No to Advanced or Metastatic Small Cells Receives: Radiation: 18FDG PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Threshold of the 18FDG Retention Index (Dual-point Acquisition), From the First Metabolic Progression Observed in 18FDG PET, to Distinguish a True Tumor Progression From a Pseudo-progression of Inflammatory Origin (Leukocyte Infiltrate)
ROC curve of the FDG retention index, defined on the dual-point PET acquisition, will be analysed to distinguish lesions in true progressions and lesions in inflammatory pseudo-progressions. The Area Under the Curve (AUC) of the Receiver Operating Characteristic (ROC) curves (Sensitivity vs. Specificity) will be evaluated to assess the predictive performance of the marker. The AUC will be calculated and analyzed across three distinct delta-SUV (ΔSUV) thresholds: a decrease of 30 (-30), an increase of 30 (30), and no change (= 0).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start4 Apr 2019
- Primary completion26 Jun 2024
- Study completion26 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Bronchopulmonary Carcinoma or MelanomaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective non-randomized, multi-center, diagnostic performance study of 18FDG PET for identification of early tumor escape to immunotherapy in patients with unresectable melanoma or Broncho-Pulmonary Carcinoma No to Advanced or Metastatic Small Cells
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Antoine Lacassagne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03584334
- Sponsor's protocol ID
- 2017/77
- Other IDs
- 2018-A00915-50
- Acronym
- FDG-IMMUN
- Status last verified
- Jul 2026
- First submitted
- 4 Jun 2018
- Last updated
- 4 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Masse M, Chardin D, Tricarico P, Ferrari V, Martin N, Otto J, Darcourt J, Comte V, Humbert O. [18F]FDG-PET/CT atypical response patterns to immunotherapy in non-small cell lung cancer patients: long term prognosis assessment and clinical management proposal. Eur J Nucl Med Mol Imaging. 2024 Oct;51(12):3696-3708. doi: 10.1007/s00259-024-06794-8. Epub 2024 Jun 19.
PubMed 38896129Correction: Total metabolic tumor volume on 18F-FDG PET/CT is a game-changer for patients with metastatic lung cancer treated with immunotherapy. J Immunother Cancer. 2024 Apr 27;12(4):e007628corr1. doi: 10.1136/jitc-2023-007628corr1. No abstract available.
PubMed 38677882Tricarico P, Chardin D, Martin N, Contu S, Hugonnet F, Otto J, Humbert O. Total metabolic tumor volume on 18F-FDG PET/CT is a game-changer for patients with metastatic lung cancer treated with immunotherapy. J Immunother Cancer. 2024 Apr 22;12(4):e007628. doi: 10.1136/jitc-2023-007628.
PubMed 38649279
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study Evaluating 18FDG PET for Early Identification of Tumor Exhaust for Immunotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Bronchopulmonary Carcinoma or Melanoma
- ClinicalTrials.gov ID
- NCT03584334
- Acronym / sponsor ID
- FDG-IMMUN / 2017/77
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Antoine LacassagneUniversity, hospital or other
- Study start
- 4 Apr 2019 (actual)
- Primary completion
- 26 Jun 2024 (actual)
- Study completion
- 26 Jun 2024 (actual)
- First posted
- 12 Jul 2018 (actual)
- Results
- Posted 4 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis of this diagnostic performance study is that, for patients treated for immunotherapy-treated melanoma or NSCLC, some metabolic parameters of the 18FDG dual-point PET scan distinguish inflammatory pseudo-progression from tumor progression true and thus improve the evaluation of tumor response to immunotherapy
Detailed description
The originality of this study is based on the stakes of the early prediction of resistance to immunotherapy (early therapeutic escapes, side effects, cost of treatment etc.).
No prospective study has been published to date on the value of 18FDG PET to distinguish between true tumor progression and pseudo-progression. Studies are therefore needed to define new criteria for evaluating the metabolic response specific to immunotherapy, as well as the optimal timing of the interim examination.
The goal is to conduct a transversal, non-randomized, prospective, multi-center, diagnostic performance study, harmonizing the moments of the 18FDG PET scans, acquisition conditions and interpretation criteria. The use of a dual-point acquisition in PET will also make it possible to judge the kinetics of 18FDG lesion capture (calculation of the 18FDG retention index on the late image) with the objective of highlighting PET criteria to distinguish between inflammatory pseudo-progression and true tumor progression in patients with unresectable melanoma or advanced or metastatic NSCLC. Other metabolic parameters will be studied, such as changes in tumor metabolic volume and binding intensities.
Finally, this study will include patients to assess the correlation between the metabolic tumor response observed after 7 weeks of immunotherapy, the morphological response after 3 months of treatment (RECIST v1.1 and i-RECIST) and survival overall at 1 year.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective non-randomized, multi-center, diagnostic performance study of 18FDG PET for identification of early tumor escape to immunotherapy in patients with unresectable melanoma or Broncho-Pulmonary Carcinoma No to Advanced or Metastatic Small Cells
| Arm | Type | Receives |
|---|---|---|
| 18FDG PET | Other | Radiation: 18FDG PETDiagnostic performance of 18FDG PET for identification of early tumor escape to immunotherapy in patients with unresectable melanoma or Broncho-Pulmonary Carcinoma No to Advanced or Metastatic Small Cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age > or = 18 years,
- Patients with unresectable melanoma or histologically proven, metastatic or locally advanced NSCLC,
- Indication of an immunotherapy treatment with nivolumab or pembrolizumab validated in multidisciplinary consultation team and prescribed as part of their marketing authorization, in first or second line of treatment,
- Performance Status 0 to 2,
- Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required,
Key exclusion criteria (10 listed)
- Age < 18 years,
- Contraindication to performing 18FDG PET scans: severe claustrophobia, unbalanced diabetes during PET examinations (fasting capillary blood glucose ≥ 11 mmol),
- Any participation in other biomedical studies related to the drug, medical devices or imaging techniques is prohibited except biomedical studies called overstudies (In case of doubt or questions about the patient's participation in a other clinical study, please contact the sponsor),
- Contraindication to nivolumab or pembrolizumab treatment,
- Patient with metastatic disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18FDG PETDiagnostic performance of 18FDG PET for identification of early tumor escape to immunotherapy in patients with unresectable melanoma or Broncho-Pulmonary Carcinoma No to Advanced or Metastatic Small Cells | Radiation | 18FDG PET |
Primary outcome
Threshold of the 18FDG Retention Index (Dual-point Acquisition), From the First Metabolic Progression Observed in 18FDG PET, to Distinguish a True Tumor Progression From a Pseudo-progression of Inflammatory Origin (Leukocyte Infiltrate)
Time frame: 12 months
ROC curve of the FDG retention index, defined on the dual-point PET acquisition, will be analysed to distinguish lesions in true progressions and lesions in inflammatory pseudo-progressions. The Area Under the Curve (AUC) of the Receiver Operating Characteristic (ROC) curves (Sensitivity vs. Specificity) will be evaluated to assess the predictive performance of the marker. The AUC will be calculated and analyzed across three distinct delta-SUV (ΔSUV) thresholds: a decrease of 30 (-30), an increase of 30 (30), and no change (= 0).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 38896129Masse M, Chardin D, Tricarico P, Ferrari V, Martin N, Otto J, Darcourt J, Comte V, Humbert O. [18F]FDG-PET/CT atypical response patterns to immunotherapy in non-small cell lung cancer patients: long term prognosis assessment and clinical management proposal. Eur J Nucl Med Mol Imaging. 2024 Oct;51(12):3696-3708. doi: 10.1007/s00259-024-06794-8. Epub 2024 Jun 19.
- Results publication: PubMed 38677882Correction: Total metabolic tumor volume on 18F-FDG PET/CT is a game-changer for patients with metastatic lung cancer treated with immunotherapy. J Immunother Cancer. 2024 Apr 27;12(4):e007628corr1. doi: 10.1136/jitc-2023-007628corr1. No abstract available.
- Derived from this study: PubMed 38649279Tricarico P, Chardin D, Martin N, Contu S, Hugonnet F, Otto J, Humbert O. Total metabolic tumor volume on 18F-FDG PET/CT is a game-changer for patients with metastatic lung cancer treated with immunotherapy. J Immunother Cancer. 2024 Apr 22;12(4):e007628. doi: 10.1136/jitc-2023-007628.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18FDG PET in people with Non-Small Cell Bronchopulmonary Carcinoma or Melanoma, run by Centre Antoine Lacassagne at 1 site 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 9 inclusion and 10 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 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 4 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Threshold of the 18FDG Retention Index (Dual-point Acquisition), From the First Metabolic Progression Observed in 18FDG PET, to Distinguish a True Tumor Progression From a Pseudo-progression of Inflammatory Origin (Leukocyte Infiltrate) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03584334, which also lists 3 linked publications.
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 4 Sep 2026.