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Pleural MesotheliomaFLT-MMNCT06410625

Evaluation of Response by FLT PET in Mesothelioma

A study testing FLT PET imaging in people with Pleural Mesothelioma and Treatment Response, run by Ankara University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Pleural mesothelioma (MPM) is an aggressive tumor that affects the pleura and originates from mesothelial cells. If untreated, median survival is 4-12 months following diagnosis. Asbestos exposure is a risk factor associated with 80% of cases. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
FLT PET imaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Apr 2024to 1 Jul 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 planned for platinum-based chemotherapy
  • Patients who gave informed consent form to participate in the study

Who cannot join

  • Being under 18 years old
  • Patients planned for immunotherapy
  • Patients who did not provide informed consent form to participate in the study

Trial locations and contacts

1 site in 1 country.

Cigdem Soydal, Asc Prof contact

+903125956732

csoydal@yahoo.com

Turkey (Türkiye)1 site, 1 recruiting
  • Ankara University Medical School

    Ankara, 06580

    Cigdem Soydal

    +903125956732, csoyal@yahoo.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Response to Chemo-Therapy by FLT PET in Mesothelioma

Pleural mesothelioma (MPM) is an aggressive tumor that affects the pleura and originates from mesothelial cells. If untreated, median survival is 4-12 months following diagnosis. Asbestos exposure is a risk factor associated with 80% of cases. After the 1980s, regulations controlling the use of asbestos ensured that cases were limited. Approximately 3,000 new cases are diagnosed each year in the United States. In general, a minority of patients are candidates for surgery at the time of presentation, so the mainstay of treatment is systemic chemotherapy. For patients who are surgical candidates, surgery is usually part of a multimodal treatment process that also includes chemotherapy and/or radiotherapy. Early and accurate diagnosis has a critical impact on the management of the disease due to limited response to multimodal treatments. Patients are often diagnosed at an advanced stage, leading to poor overall survival. Thorax and upper abdomen CT imaging are standard initial imaging modalities for clinical staging of MPM. Although CT identifies the general extent of the primary tumor, it may not definitively identify some areas of tumor invasion. There may be difficulties especially in the evaluation of chest wall and diaphragm invasion.

18F-FDG PET/CT has been widely used for cancer diagnosis, staging, treatment response and prognostic information for many years with high accuracy rates. 18F-FDG PET/CT provides valuable information on differentiating benign and malignant pleural abnormalities, evaluating the possibility of malignant involvement of mediastinal and hilar lymph nodes, and detecting distant metastases. 18F-FDG PET/CT identifies metastatic disease undetected on CT in approximately 10% of patients. At the same time, the degree of involvement (SUV) in FDG PET plays a role in predicting disease prognosis. 18F-FDG PET/CT can also be used to evaluate the treatment response in patients receiving chemotherapy, but due to chemotherapy-related inflammatory changes, it is necessary to wait at least 2 weeks to evaluate the treatment response.

Read more

18F-Fluorothymidine (FLT) is a thymidine kinase 1-specific substrate that is increased in proliferating cells and is associated with the Ki-67 index, a proliferation marker. It allows noninvasive evaluation of cell proliferation, especially the early evaluation of the response to cytotoxic chemotherapy. 18F-FLT PET/CT imaging has shown success in early evaluation of response to systemic endocrine, chemotherapy, radiotherapy and combined chemotherapy in multiple tumor types. The prognostic value of a decrease in 18F-FLT uptake after initiation of treatment has also been reported.

In this study, it is aimed to evaluate the success of 18F-FLT PET/CT in the early evaluation of the response after the first cycle of chemotherapy in patients diagnosed with mesothelioma and receiving systemic chemotherapy. It is also aimed to evaluate the prognostic value of response evaluation made with this method.

It is planned to prospectively include 25 patients with MPM who scheduled for chemotherapy in the study. Included patients will undergo 18F-FDG PET/CT before chemotherapy followed by 18F-FLT PET/CT imaging within two weeks. 18F-FLT PET/CT will be performed on the 4th day after the 1st cycle of chemotherapy. After chemotherapy is completed, treatment response will be evaluated with 18F-FDG PET/CT. Patients will then be followed by their clinicians for relapse and progressive disease. Thus, the success of early 18F-FLT PET/CT in predicting end of treatment response will be evaluated.

Being tested
FLT PET imaging
Medical subject headings
Mesothelioma, Malignant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FLT PET imagingDiagnostic test

    Also called FDG PET

    Evaluation of response to chemotherapy with FLT PET imaging

Study groups in NCT06410625
Study groupRoleWhat they receive
Treatment armExperimentalPatients who will receive standardized chemotherapy for pleural mesothelioma
Receives: Diagnostic Test: FLT PET imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The early treatment response by FLT PET

    Evaluation of the response to chemotherapy with change in the uptake of FLT in PET in pleural mesothelioma patients

    Measured: 1-4 days

Secondary outcomes (1)
  1. The prognostic importance of treatment response evaluated with FLT PET

    Evaluation of the predictive value for progression free survival and overall survival of FLT PET reponse after chemotherapy

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2024
  2. Study start1 Apr 2024
  3. Primary completion1 Apr 2025 (estimated)
  4. Study completion1 Jul 2025 (estimated)

Resources

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
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06410625
Sponsor's protocol ID
FLT-MM
Acronym
FLT-MM
Status last verified
May 2024
First submitted
27 Mar 2024
Last updated
16 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing FLT PET imaging in people with Pleural Mesothelioma and Treatment Response, 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 3 inclusion and 3 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 16 May 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?

Contact Cigdem Soydal, Asc Prof (+903125956732, csoydal@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The early treatment response by FLT PET (time frame: 1-4 days). 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 16 May 2024.

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