Ga-68 FAPI PET Before Immunotherapy

NCT ID: NCT06451536

Last Updated: 2024-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-30

Study Completion Date

2025-04-30

Brief Summary

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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

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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.

Conditions

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Mesotheliomas Pleural

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

prediction of immunotherapy response with Ga-68 FAPI PET
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Treatment arm

Patients underwent Ga68 FAPI PET before immunotherapy

Group Type EXPERIMENTAL

Ga-68 FAPI PET/CT

Intervention Type DIAGNOSTIC_TEST

imaging of FAP expression of tumor before immunotherapy

Interventions

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Ga-68 FAPI PET/CT

imaging of FAP expression of tumor before immunotherapy

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Liv Hospital Ankara

OTHER

Sponsor Role collaborator

Social Sciences University of Ankara

OTHER

Sponsor Role collaborator

Ankara Yildirim Beyazıt University

OTHER

Sponsor Role collaborator

Ankara University

OTHER

Sponsor Role lead

Responsible Party

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Cigdem Soydal

AsC Prof of Nuclear Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ankara University School of Medicine

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Facility Contacts

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Cigdem Soydal, Asc Prof

Role: primary

+903125957632

Other Identifiers

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FAPBI Trial

Identifier Type: -

Identifier Source: org_study_id

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