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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