Non-Small Cell Bronchopulmonary Carcinoma or Melanoma
Conditions
Brief 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 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.
Interventions
RADIATION18FDG PET
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
Sponsors
Centre Antoine Lacassagne
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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). |
Countries
France
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized Age range 40-49 years | 7 Participants |
| Age, Customized Age range 50-59 years | 18 Participants |
| Age, Customized Age range 60-69 years | 35 Participants |
| Age, Customized Age range 70-79 years | 26 Participants |
| Age, Customized Age range > 80 years | 9 Participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 15 / 95 |
| other Total, other adverse events | 86 / 95 |
| serious Total, serious adverse events | 40 / 95 |
Outcome results
None listed