18FDG PET for Early Identification of Tumor Exhaust for Immunotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Bronchopulmonary Carcinoma or Melanoma

NCT03584334 | Completed DMC

• 2 other identifiers: 2017/772018-A00915-50
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Non-Small Cell Bronchopulmonary Carcinoma or Melanoma

Outcome Measures

Primary Outcomes (1)

• 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)

  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.

  12 months

Secondary Outcomes (11)

• PET criteria other than the 18FDG retention index to distinguish pseudo-progressions from true tumor progressions for new lesions: intensity of fixation (SUVpeak) and location of new lesions

  12 months

• PET criteria other than the 18FDG retention index to distinguish pseudo-progressions from true tumor progressions for new lesions: intensity of fixation (SUVpeak) and location of new lesions

  12 months

• PET criteria other than the 18FDG retention index to distinguish pseudo-progressions from true tumor progressions for new lesions: intensity of fixation (SUVpeak) and location of new lesions

  12 months

• PET criteria other than the 18FDG retention index to distinguish pseudo-progressions from true tumor progressions for new lesions: intensity of fixation (SUVpeak) and location of new lesions

  12 months

• The incidence of inflammatory pseudo-progression compared to true tumor progressions, taking into account the impact of the primary tumor

  12 months

Study Arms (1)

18FDG PET

OTHER

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

Radiation: 18FDG PET

Interventions

18FDG PET RADIATION

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

18FDG PET

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Antoine Lacassagne: lead

Study Sites (1)

Centre Antoine Lacassagne

Nice, 06189, France

Location

Related Publications (1)

• Tricarico 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 DERIVED

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: July 12, 2018
• Study Start: April 4, 2019
• Primary Completion: June 26, 2024
• Study Completion: June 26, 2024
• Last Updated: September 30, 2025

Record last verified: 2024-08

Locations

FR (1)