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Recruiting NCT06833229

Prospective Cohort Study Evaluating 18FDG PET-CT for the Early Prediction of the Efficacy of Immunotherapy Associated or Not With Chemotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Broncho-Pulmonary Carcinoma

— Observational Carcinoma, Non-Small-Cell Lung (NSCLC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FDG-PET.
Who it may be relevant to
Registry conditions: Carcinoma, Non-Small-Cell Lung (NSCLC). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Procedure FDG-PET
    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.

Primary outcome measures

  • Metabolic criteria for PET imaging that can distinguish true tumor progression from pseudo-progression of inflammatory origin (leukocyte infiltrate) [Time frame: 36 months]
Secondary outcome measures (4)
  • Incidence of pseudo-progressions versus true tumor progressions at the first PET scan at 6 weeks. [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 [Time frame: 36 months]
  • Use of supervised deep-learning algorithms (neural networks) to classify patients as immunotherapy responders or non-responders. [Time frame: 6 months]
  • Evaluation of overall survival of patients with oligometastatic progression with maintenance of immunotherapy and targeted irradiation of progressing lesions. [Time frame: 36 months]

Eligibility criteria

Inclusion criteria

  • Age greater than or equal to 18 years,
  • Patients with histologically proven, metastatic or locally advanced NSCLC, with indication for immunotherapy (Nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab), in combination or not with chemotherapy molecules (carboplatin, cisplatin, pemetrexed, paclitaxel or nab-paclitaxel), validated by a Multidisciplinary Team and prescribed within the scope of their Marketed Authorization, whatever the line of treatment treatment line,
  • ECOG 0 to 3,
  • The patient's understanding of the protocol and the note of non-opposition, with oral agreement,
  • Patient has not objected to the use of his or her data for medical research. research,
  • Patient has social security coverage.

Exclusion criteria

  • Age under 18,
  • Contraindication to 18FDG PET-CT examinations: severe claustrophobia, unbalanced diabetes at the time of the first PET-CT scan (fasting capillary glucose ≥ 11 mmol),
  • Hemoglobin less than 7 g/dL at inclusion. If the patient has a respiratory or or cardiovascular pathology, hemoglobin must not be less than 9.0 g/dL,
  • Any participation in other biomedical studies involving the drug, medical devices or medical devices or imaging techniques is prohibited, with the exception of biomedical studies,
  • Refusal to participate in the present study,
  • Contraindication (e.g. hypersensitivity to the active substance or to one of the excipients of immunotherapy or chemotherapy treatments...).
  • Vulnerable persons are defined in article L1121-5 to -8:
  • Pregnant women, parturients and nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons hospitalized without consent under articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of the provisions of article L. 1121-8,
  • and persons admitted to a health or social establishment for purposes other than research purposes,
  • adults who are the subject of a legal protection measure, or who are unable to exercise their non opposition

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Centre Antoine Lacassagne — Nice

Identifiers

NCT: NCT06833229 · 2021/11 · 2021-A00352-39

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗