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New treatment option for Pleural Mesothelioma
Official title The Diagnostic Accuracy and Clinical Value of FAPI PET in Pleural Mesothelioma
ClinicalTrials.gov ID: NCT06790082
What this study is testing
What is [68Ga]Ga-FAPI-46 PET/CT?
[68Ga]Ga-FAPI-46 PET/CT is an investigational medicine, being studied as a potential treatment for pleural mesothelioma.
Also referred to as [68Ga]Gallium - Fibroblast Activation Protein Inhibitor-46 Positron Emission Tomography / Computer Tomography.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Seventy (N=70) patients with suspected pleural mesothelioma (PM) lesions referred to pleural biopsy will be recruited, and undergo an additional FAPI PET/CT at primary staging. The FAPI PET/CT results will be compared to conventional imaging (including FDG PET/CT).
- Phase 2: a mid-size study of how well it works
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with pleural lesions suspicious of pleural mesothelioma and referred to pleural biopsy.
- Undergone/undergoing FDG PET/CT as part of the diagnostic workup of a suspicious PM lesion.
- Considered physically and mentally able to participate in the research project.
- Understands the study subject information and able to consent to project participation.
- 18-years or older
You likely can't join if
- Patients with an imminent need for surgery or in an emergency
- Known concurrent other malignancy with active treatment within the last 1 year; non-melanoma skin cancer and cervical cancer in situ are exempt.
- Pregnant or breastfeeding women.
- Fertile women (women of childbearing potential) who could - theoretically - be pregnant (i.e., unknown pregnancy status). Fertile women will be...
- people unable to undergo PET/CT: e.g., weighing more than 180 kg (weight limit scanner), unable to fit within the imaging gantry, inability to remain...
- people with any medical condition or other circumstances that, in the opinion of the Investigator, would significantly decrease the reliability of...
See the full eligibility criteria
- Patients with pleural lesions suspicious of pleural mesothelioma and referred to pleural biopsy.
- Undergone/undergoing FDG PET/CT as part of the diagnostic workup of a suspicious PM lesion.
- Considered physically and mentally able to participate in the research project.
- Understands the study subject information and able to consent to project participation.
- 18-years or older
- Patients with an imminent need for surgery or in an emergency
- Known concurrent other malignancy with active treatment within the last 1 year; non-melanoma skin cancer and cervical cancer in situ are exempt.
- Pregnant or breastfeeding women.
- Fertile women (women of childbearing potential) who could - theoretically - be pregnant (i.e., unknown pregnancy status). Fertile women will be tested for pregnancy (by urine humane choriogonadotropin (HCG) or serum...
- people unable to undergo PET/CT: e.g., weighing more than 180 kg (weight limit scanner), unable to fit within the imaging gantry, inability to remain still for the duration of the examination, or with known severe...
- people with any medical condition or other circumstances that, in the opinion of the Investigator, would significantly decrease the reliability of data, achievement of study objectives or completing the study.
- History of allergic reactions / hypersensitivity attributed to [18F]FDG or FAPI-tracers.
The study team makes the final eligibility decision.
Where it's taking place
- Aalborg, Region North Jutland, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aalborg, Region North Jutland, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.