Correlation of Metabolic Imaging With Immune Markers in NSCLC Candidate to Immunotherapy.

April 27, 2022 updated by: Istituto Clinico Humanitas

Correlazione Dell'Imaging Metabolico Con l'Espressione Dei Marcatori Immunitari Nei Pazienti Con NSCLC Candidati All'Immunoterapia.

The purpose of the present study is to prospectively investigate the correlation between the metabolic parameters on FDG-PET before and during immunotherapy treatment with the immune infiltrate and other tissue or circulating markers in a NSCLC patients candidate to immunotherapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an interventional prospective study without medication lasting 36 months, including an estimated period of 18 months for the enrolment and max 18 months of follow-up. All consecutive patients affected by NSCLC and referred for immunotherapy with the anti-PD-1 agent nivolumab, or other checkpoint inhibitors that may become available in the future, will be prospectively enrolled. The study cohort will consist of 40 patients.

All patients will undergo the following steps: 1) selection based on eligibility criteria and informed consent; 2) baseline examinations (ceCT and 18F-FDG PET/CT); 3) tumor biopsy and blood sampling; 4) Immunotherapy with check-point inhibitors; 5) response evaluation after 8 weeks of treatment (ceCT and 18F-FDG PET/CT) and second blood sampling; 6) follow up.

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Recruiting
        • Istituto Clinico Humanitas
        • Contact:
        • Sub-Investigator:
          • Fabio grizzi, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with pathological diagnosis of NSCLC eligible for immunotherapy;
  • obtained informed consent.

Exclusion Criteria:

  • age <18 years;
  • pregnancy or breast-feeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Biopsy and PET scan
Diagnostic test: PET scan
Tumor biopsy at baseline; PET scan performed after 8 weeks of treatment
Other Names:
  • Biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlate the tumor expression of immune markers with the metabolic characteristics on FDG-PET in patients with NSCLC candidates to immunotherapy.
Time Frame: Baseline
Standardized uptake value
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor expression of immune markers with the metabolic characteristics on FDG-PET in patients with NSCLC candidates to immunotherapy.
Time Frame: Before treatment
Metabolic tumor burden
Before treatment
Correlate immune markers with the metabolic characteristics on FDG-PET in patients with NSCLC candidates to immunotherapy.
Time Frame: Baseline
Tumor infiltrate
Baseline
Evaluate the variation of metabolic parameters on FDG-PET in patients with NSCLC before and 8 weeks after the first administration of immunotherapy.
Time Frame: After 8 weeks of treatment
Standardized uptake value
After 8 weeks of treatment
Quantify the variation of metabolic parameters on FDG-PET in patients with NSCLC before and 8 weeks after the first administration of immunotherapy.
Time Frame: After 8 weeks of treatment
Metabolic tumor burden
After 8 weeks of treatment
Evaluate other tissue or circulating markers in patients with NSCLC before and 8 weeks after the first administration of immunotherapy.
Time Frame: Baseline
Tissue and blood samples
Baseline
Evaluate other tissue or circulating markers in patients with NSCLC before and 8 weeks after the first administration of immunotherapy.
Time Frame: 8 weeks after treatment
Tissue and blood samples
8 weeks after treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlate all defined parameters with response to treatment and outcome
Time Frame: 18 months of follow up
Response assessment and disease outcome
18 months of follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

Investigators

  • Principal Investigator: Egesta Lopci, Istituto Clinico Humanitas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

June 8, 2018

First Submitted That Met QC Criteria

June 19, 2018

First Posted (Actual)

June 20, 2018

Study Record Updates

Last Update Posted (Actual)

April 28, 2022

Last Update Submitted That Met QC Criteria

April 27, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1670

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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