Ga-68 FAPI PET Before Immunotherapy

NCT06451536 | Recruiting

• 1 other identifier: FAPBI Trial
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Mesotheliomas Pleural

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

Treatment arm

EXPERIMENTAL

Patients underwent Ga68 FAPI PET before immunotherapy

Diagnostic Test: Ga-68 FAPI PET/CT

Interventions

Ga-68 FAPI PET/CT DIAGNOSTIC_TEST

imaging of FAP expression of tumor before immunotherapy

Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ankara University: lead
• Liv Hospital Ankara: collaborator
• Social Sciences University of Ankara: collaborator
• Ankara Yildirim Beyazıt University: collaborator

Study Sites (1)

Ankara University School of Medicine

Ankara, 06590, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Mesothelioma, Malignant

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: AsC Prof of Nuclear Medicine

Model Details: prediction of immunotherapy response with Ga-68 FAPI PET

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: June 11, 2024
• Study Start: April 30, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: June 11, 2024

Record last verified: 2024-06

Locations

TU (1)