Mesotheliomas PleuralFAPBINCT06451536
Ga-68 FAPI PET Before Immunotherapy
A study testing Ga-68 FAPI PET/CT in people with Mesotheliomas Pleural, run by Ankara University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mesotheliomas Pleural
- What is being tested?
- Ga-68 FAPI PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Apr 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- ECOG>2
- Patients who did not provide informed consent form to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara University School of Medicine
Ankara, 06590
Cigdem Soydal, Asc Prof, +903125957632, csoydal@ankara.edu.tr
About this study
Official title: Prognostic Significance of Ga-68 FAPI PET Before Immunotherapy in Pleural Mesothelioma
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.
Read the 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.
- Conditions
- Mesotheliomas Pleural
- Being tested
- Ga-68 FAPI PET/CT
- Medical subject headings
- Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ga-68 FAPI PET/CTDiagnostic test
imaging of FAP expression of tumor before immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Patients underwent Ga68 FAPI PET before immunotherapy Receives: Diagnostic Test: Ga-68 FAPI PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of immune therapy response with Ga-68 FAPI PET
prediction of immunotherapy response with SUVmax measured with Ga-68 FAPI PET before immunotherapy
Measured: 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
Measured: 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
Measured: 6. month after initiation of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start30 Apr 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mesotheliomas PleuralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prediction of immunotherapy response with Ga-68 FAPI PET
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Collaborators
- Liv Hospital Ankara, Social Sciences University of Ankara, Ankara Yildirim Beyazıt University
- Responsible party
- Principal investigator, Cigdem Soydal, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451536
- Sponsor's protocol ID
- FAPBI Trial
- Acronym
- FAPBI
- Status last verified
- Jun 2024
- First submitted
- 17 May 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Significance of Ga-68 FAPI PET Before Immunotherapy in Pleural Mesothelioma
- ClinicalTrials.gov ID
- NCT06451536
- Acronym / sponsor ID
- FAPBI / FAPBI Trial
- Conditions
- Mesotheliomas Pleural
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Collaborators
- Liv Hospital Ankara, Social Sciences University of Ankara, Ankara Yildirim Beyazıt University
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prediction of immunotherapy response with Ga-68 FAPI PET
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Diagnostic Test: Ga-68 FAPI PET/CTPatients underwent Ga68 FAPI PET before immunotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- ECOG>2
- Patients who did not provide informed consent form to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ga-68 FAPI PET/CTimaging of FAP expression of tumor before immunotherapy | Diagnostic test | Treatment arm |
Primary outcome
Prediction of immune therapy response with Ga-68 FAPI PET
Time frame: 6. month after initiation of therapy
prediction of immunotherapy response with SUVmax measured with Ga-68 FAPI PET before immunotherapy
Prediction of immune therapy response with Ga-68 FAPI PET
Time frame: 6. month after initiation of therapy
prediction of immunotherapy response with total FAPI volume measured with Ga-68 FAPI PET before immunotherapy
Prediction of immune therapy response with Ga-68 FAPI PET
Time frame: 6. month after initiation of therapy
prediction of immunotherapy response with total lesion FAPI uptake measured with Ga-68 FAPI PET before immunotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ga-68 FAPI PET/CT in people with Mesotheliomas Pleural, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of immune therapy response with Ga-68 FAPI PET (time frame: 6. month after initiation of therapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024; AzTrials last refreshed its copy on 1 Nov 2026.