Clinical trial · Interventional
18FDG PET for Early Identification of Tumor Exhaust for Immunotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Bronchopulmonary Carcinoma or Melanoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Bronchopulmonary Carcinoma or Melanoma | Melanoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18FDG PET | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- 18FDG PET
- description
- 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
- interventionNames
- Radiation: 18FDG PET
Primary outcomes (1)
- 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)
- timeFrame
- 12 months
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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, * 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. Exclusion Criteria: * 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, * 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.
References
Publications (3)
- RESULTMasse 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. PMID 38896129
- RESULTCorrection: 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. PMID 38677882
- DERIVEDTricarico 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. PMID 38649279