Ga-68 FAPI PET Before Immunotherapy

Not Applicable

Recruiting

• Conditions: Mesotheliomas Pleural
• Interventions: Diagnostic Test: Ga-68 FAPI PET/CT

• Registration Number: NCT06451536
• Lead Sponsor: Ankara University

Brief Summary

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.

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 Timeline

• Study Start: 2024-04-30
• Study First Submitted: 2024-05-17
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-04
• Last Update Submitted: 2024-06-04
• Study First Posted: 2024-06-11
• Last Update Posted: 2024-06-11
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment arm	Ga-68 FAPI PET/CT	Patients underwent Ga68 FAPI PET before immunotherapy

Primary Outcome Measures

Name	Time	Method
Prediction of immune therapy response with Ga-68 FAPI PET	6. month after initiation of therapy	prediction of immunotherapy response with total lesion FAPI uptake measured with Ga-68 FAPI PET before immunotherapy

Trial Locations

Locations (1)

Ankara University School of Medicine; 🇹🇷 Ankara, Turkey