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Trial Title: Ga-68 FAPI PET Before Immunotherapy

NCT ID: NCT06451536

Condition: Mesotheliomas Pleural

Conditions: Official terms:
Mesothelioma
Mesothelioma, Malignant

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: prediction of immunotherapy response with Ga-68 FAPI PET

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Diagnostic Test
Intervention name: Ga-68 FAPI PET/CT
Description: imaging of FAP expression of tumor before immunotherapy
Arm group label: Treatment arm

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Ankara University School of Medicine

Address:
City: Ankara
Zip: 06590
Country: Turkey

Status: Recruiting

Contact:
Last name: Cigdem Soydal, Asc Prof

Phone: +903125957632
Email: csoydal@ankara.edu.tr

Start date: April 30, 2024

Completion date: April 30, 2025

Lead sponsor:
Agency: Ankara University
Agency class: Other

Collaborator:
Agency: Liv Hospital Ankara
Agency class: Other

Collaborator:
Agency: Social Sciences University of Ankara
Agency class: Other

Collaborator:
Agency: Ankara Yildirim Beyazıt University
Agency class: Other

Source: Ankara University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06451536

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