Ga-68 FAPI PET Before Immunotherapy (FAPBI)

June 4, 2024 updated by: Cigdem Soydal, Ankara University

Prognostic Significance of Ga-68 FAPI PET Before Immunotherapy in Pleural Mesothelioma

It is aimed to evaluate FAP expression and its success in predicting treatment response before immunotherapy used in the treatment of malignant mesothelioma with Ga68 FAPI PET/CT imaging, which allows in vivo evaluation of FAP expression, which is thought to be associated with immunosuppression and resistance to immunotherapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients diagnosed with pleural mesothelioma and planned for immunotherapy will be included in the study. Patients will undergo Ga68 FAPI PET/CT imaging within 10 days before the start of immunotherapy treatment, and SUVmax, SUVmean, metabolic tumor volume and total Ga68 FAPI uptake parameters will be obtained from the tumors. Following this, the routine treatment and follow-up of the patients will be carried out by their clinicians. It will be evaluated whether there is a correlation between treatment response and initial Ga-68 FAPI PET findings.

Study Type

Interventional

Enrollment (Estimated)

30

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 Locations

  • Turkey
      • Ankara, Turkey, 06590
        • Recruiting
        • Ankara University School of Medicine
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Having a histopathologically confirmed diagnosis of
  • Pleural Mesolthelioma
  • Patients scheduled for immunotherapy with anti-PDL-1 and/or anti-CTLA-4 antibodies as first or second line therapy
  • Patients who gave informed consent form to participate in the study

Exclusion Criteria:

  • ECOG>2
  • Patients who did not provide informed consent form to participate in the study

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: Treatment arm
Patients underwent Ga68 FAPI PET before immunotherapy
Diagnostic test: Ga-68 FAPI PET/CT
imaging of FAP expression of tumor before immunotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prediction of immune therapy response with Ga-68 FAPI PET
Time Frame: 6. month after initiation of therapy
prediction of immunotherapy response with SUVmax measured with Ga-68 FAPI PET before immunotherapy
6. month after initiation of therapy
Prediction of immune therapy response with Ga-68 FAPI PET
Time Frame: 6. month after initiation of therapy
prediction of immunotherapy response with total FAPI volume measured with Ga-68 FAPI PET before immunotherapy
6. month after initiation of therapy
Prediction of immune therapy response with Ga-68 FAPI PET
Time Frame: 6. month after initiation of therapy
prediction of immunotherapy response with total lesion FAPI uptake measured with Ga-68 FAPI PET before immunotherapy
6. month after initiation of therapy

Collaborators and Investigators

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

Sponsor

Ankara University

Collaborators

Ankara Yildirim Beyazıt University
Liv Hospital Ankara
Social Sciences University of Ankara

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)

April 30, 2024

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

May 17, 2024

First Submitted That Met QC Criteria

June 4, 2024

First Posted (Actual)

June 11, 2024

Study Record Updates

Last Update Posted (Actual)

June 11, 2024

Last Update Submitted That Met QC Criteria

June 4, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAPBI Trial

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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