Allogeneic Stem Cell Transplantation study: [18F]FAPI-74
Official title Fibrotic Disease Activity in Cardiopulmonary Disorders Using 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) PET/CT Imaging
ClinicalTrials.gov ID: NCT07613099
What this study is testing
What is [18F]FAPI-74?
an investigational radioactive tracer being studied for imaging fibrosis in heart and lung disease during allogeneic stem cell transplantation trials
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
- This study is testing whether a new tracer can show early scar tissue. It aims to find damage before it gets worse.
- Who it's for
- You may be able to join if you are 18 or older with heart or lung disease.
- What's involved
- You would get a small amount of a special dye in your arm. You would then lie on a bed that slides through a scanner.
- Time commitment
- The study lasts two years with six visits to the clinic.
- Phase 3: a large, late-stage study
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Participant \>=18 years old
- Has a specific diagnosis of a cardiopulmonary and/or vascular disease that puts them at risk of developing or having developed tissue fibrosis.
- Has undergone prior imaging of lungs, heart, and/or vasculature with chest CT
You likely can't join if
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-FAPI-74 or other agents used in the study.
- Uncontrolled intercurrent illness, factors, or social situations that would limit compliance with study requirements
- Pregnancy or lactation
- Women able to become pregnant or men actively trying to father a child and are unwilling to use an effective form of birth control during the study...
- people with severe claustrophobia unresponsive to oral anxiolytics.
- people weighing \> 350 lbs (weight limit for PET scanner table), or unable to fit within the imaging gantry
See the full eligibility criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Participant \>=18 years old
- Has a specific diagnosis of a cardiopulmonary and/or vascular disease that puts them at risk of developing or having developed tissue fibrosis.
- Has undergone prior imaging of lungs, heart, and/or vasculature with chest CT
- Able to lie on the PET/CT scanner for imaging up to 45 minutes.
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the...
- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study participation and for an additional 4 weeks after the end of FAPI-PET/CT or the FDG PET/CT...
- Ability of subject to understand and the willingness to sign a written informed consent document.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-FAPI-74 or other agents used in the study.
- Uncontrolled intercurrent illness, factors, or social situations that would limit compliance with study requirements
- Pregnancy or lactation
- Women able to become pregnant or men actively trying to father a child and are unwilling to use an effective form of birth control during the study and 4 weeks after the last 18F-FAPI-74 PET/CT scan or the FDG PET/CT...
- people with severe claustrophobia unresponsive to oral anxiolytics.
- people weighing \> 350 lbs (weight limit for PET scanner table), or unable to fit within the imaging gantry
The study team makes the final eligibility decision.
Where it is enrolling
- Bethesda, Maryland, United States
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, but confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bethesda, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.