The hypothesis of this prospective observational pilot study of diagnostic diagnostic performance is that, for patients with NSCLC treated with immunotherapy associated or not with chemotherapy, certain metabolic biomarkers on 18FDG PET scans allow early identification of treatment response (or lack of response to treatment) and optimize prediction of tumor response compared with current standards.
Study Type
OBSERVATIONAL
Enrollment
200
PET scan are performed within 28 days before the start of immunotherapy, then at week 6 and week 12 of follow-up. Various metabolic parameters extracted from the standard PET image (ΔSUVmax, ΔTLG, appearance of new visceral lesion(s)), parametric (metabolic glucose rate (Ki), volume of distribution (VD)) and tumor response based on PERCIST criteria (adapted to immunotherapy) are assessed.
Centre Antoine Lacassagne
Nice, France
RECRUITINGMetabolic criteria for PET imaging that can distinguish true tumor progression from pseudo-progression of inflammatory origin (leukocyte infiltrate)
Calculation of the area of the ROC curve and determination of the optimal threshold of different metabolic parameters extracted from the standard PET image (ΔSUVmax, ΔTLG, appearance of new visceral lesion(s)) and parametric PET image (metabolic glucose rate (Ki), volume of distribution (VD)) to distinguish lesions between true progression from inflammatory pseudoprogressions.
Time frame: 36 months
Incidence of pseudo-progressions versus true tumor progressions at the first PET scan at 6 weeks.
Evaluation of the ratio between lesions with pseudo-inflammatory progression and those with true tumor progression (defined a posteriori on control PET-CT). A analysis per lesion and per patient. Two groups of patients will be compared: the group treated with immunotherapy alone and the group treated with a combination of immunotherapy and chemotherapy
Time frame: 6 weeks
Prognostic value of metabolic response PET-CT at 6 weeks and 12 weeks on overall survival at 12, 24 and 36 months
Overall survival at 12, 24 and 36 months as a function of changes in tumor metabolism on the first interim PET-CT scans (PERCIST and ΔSUV analysis). Overall survival: time from date of inclusion to date of death from any cause.
Time frame: 36 months
Use of supervised deep-learning algorithms (neural networks) to classify patients as immunotherapy responders or non-responders.
Non-responders will be defined as patients who discontinue immunotherapy within the first 6 months of treatment due to tumor progression. Responders will be defined by continuation of immunotherapy beyond 6 months of treatment.
Time frame: 6 months
Evaluation of overall survival of patients with oligometastatic progression with maintenance of immunotherapy and targeted irradiation of progressing lesions.
Overall survival at 24 months as a function of whether or not irradiation (as part of standard practices) of progressing lesions in patients with metastatic oligo-progression on 18FDG PET (between 1 and 3 progressive lesions).
Time frame: 36 months
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