Ga-68 FAPI PET Before Immunotherapy

Mesotheliomas Pleural Clinical Trial

— FAPBI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06451536
• Other study ID #: FAPBI Trial
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: June 2024
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mesothelioma
• Mesothelioma, Malignant
• Mesotheliomas Pleural

Intervention

Diagnostic Test:
• Ga-68 FAPI PET/CT
imaging of FAP expression of tumor before immunotherapy

Locations

Country	Name	City	State
Turkey	Ankara University School of Medicine	Ankara

Sponsors (4)

Lead Sponsor	Collaborator
Ankara University	Ankara Yildirim Beyazit University, Liv Hospital Ankara, Social Sciences University of Ankara

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prediction of immune therapy response with Ga-68 FAPI PET	prediction of immunotherapy response with SUVmax measured with Ga-68 FAPI PET before immunotherapy	6. month after initiation of therapy
Primary	Prediction of immune therapy response with Ga-68 FAPI PET	prediction of immunotherapy response with total FAPI volume measured with Ga-68 FAPI PET before immunotherapy	6. month after initiation of therapy
Primary	Prediction of immune therapy response with Ga-68 FAPI PET	prediction of immunotherapy response with total lesion FAPI uptake measured with Ga-68 FAPI PET before immunotherapy	6. month after initiation of therapy