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

Last updated: April 9, 2025
Sponsor: Centre Antoine Lacassagne
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carcinoma

Treatment

FDG-PET

Clinical Study ID

NCT06833229
2021/11
2021-A00352-39
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age greater than or equal to 18 years,

  • Patients with histologically proven, metastatic or locally advanced NSCLC, withindication for immunotherapy (Nivolumab, pembrolizumab, atezolizumab, durvalumab,avelumab), in combination or not with chemotherapy molecules (carboplatin,cisplatin, pemetrexed, paclitaxel or nab-paclitaxel), validated by aMultidisciplinary Team and prescribed within the scope of their MarketedAuthorization, whatever the line of treatment treatment line,

  • ECOG 0 to 3,

  • The patient's understanding of the protocol and the note of non-opposition, withoral agreement,

  • Patient has not objected to the use of his or her data for medical research.research,

  • Patient has social security coverage.

Exclusion

Exclusion Criteria:

  • Age under 18,

  • Contraindication to 18FDG PET-CT examinations: severe claustrophobia, unbalanceddiabetes 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 orcardiovascular pathology, hemoglobin must not be less than 9.0 g/dL,

  • Any participation in other biomedical studies involving the drug, medical devices ormedical devices or imaging techniques is prohibited, with the exception ofbiomedical studies,

  • Refusal to participate in the present study,

  • Contraindication (e.g. hypersensitivity to the active substance or to one of theexcipients of immunotherapy or chemotherapy treatments...).

  • Vulnerable persons are defined in article L1121-5 to -8:

  • Pregnant women, parturients and nursing mothers, persons deprived of theirliberty by judicial or administrative decision, persons hospitalized withoutconsent under articles L. 3212-1 and L. 3213-1 who are not covered by theprovisions of the provisions of article L. 1121-8,

  • and persons admitted to a health or social establishment for purposes otherthan research purposes,

  • adults who are the subject of a legal protection measure, or who are unable toexercise their non opposition

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: FDG-PET
Phase:
Study Start date:
January 27, 2022
Estimated Completion Date:
January 27, 2031

Connect with a study center

  • Centre Antoine Lacassagne

    Nice, 06189
    France

    Active - Recruiting

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