Ga-68 FAPI PET Before Immunotherapy (FAPBI)

Ankara University

Status: Enrolling

Conditions: Mesotheliomas Pleural

Treatments: Diagnostic Test: Ga-68 FAPI PET/CT

Study type: Interventional

Funder types: Other

Identifiers

NCT06451536

FAPBI Trial

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Treatment arm

Experimental group

Description:

Patients underwent Ga68 FAPI PET before immunotherapy

Treatment:

Diagnostic Test: Ga-68 FAPI PET/CT