Recruiting PHASE2 Fibrosis Lung

New treatment option for Fibrosis Lung

Official title Development of FAPI PET as a Non-invasive Biomarker of Pulmonary Fibrogenesis

ClinicalTrials.gov ID: NCT06940427

What this study is testing

What is FAPI tracer?

FAPI tracer is an investigational medicine, being studied as a potential treatment for fibrosis lung.

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
The goal of this clinical trial is to gain more information about how fibroblast activation protein inhibitor (FAPI) binds to a certain type of cells in fibrotic lung tissue and how this information can be used to better diagnose and track fibrotic lung disease activity. Participants will undergo up to 4 PET/MRI scans using the FAPI radiotracer.
  • Phase 2: a mid-size study of how well it works

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

  • Age 18 years or older
  • Able and willing to provide informed consent
  • Group A: Clinically evaluated for need for initiation of new treatment (in patients not on current treatment), initiation of change in current...
  • Group B: Clinically evaluated and stable without need for initiation of new treatment (in patients not on current treatment), initiation of change in...
  • Crossover (Group B to A): Enrolled in Group B and found at next SOC clinical follow up to have need for initiation of new treatment (in patients not...

You likely can't join if

  • Participant is unable or unwilling to provide informed consent
  • Participant is pregnant
  • Participant with contraindication(s) to or inability to undergo PET/MRI
  • Participants with contraindications to GBCA will be asked to undergo research imaging without the use of contrast. Contraindications may be severe...
See the full eligibility criteria
Who can join
  • Age 18 years or older
  • Able and willing to provide informed consent
  • Group A: Clinically evaluated for need for initiation of new treatment (in patients not on current treatment), initiation of change in current treatment, or addition of new treatment (to any current treatment) in the...
  • Group B: Clinically evaluated and stable without need for initiation of new treatment (in patients not on current treatment), initiation of change in current treatment, nor addition of new treatment (to any current...
  • Crossover (Group B to A): Enrolled in Group B and found at next SOC clinical follow up to have need for initiation of new treatment (in patients not on current treatment), initiation of change in current treatment, or...
  • Willing and able to undergo PET/MRI.
  • Participants requiring intravenous (IV) conscious sedation for imaging are not eligible; participants requiring mild, oral anxiolytics for the clinical MRI will be allowed to participate as long as the following...
  • The subject has their own prescription for the medication
  • Informed consent is obtained prior to the self-administration of this medication
  • They come to the research visit with a driver
What rules you out
  • Participant is unable or unwilling to provide informed consent
  • Participant is pregnant
  • Participant with contraindication(s) to or inability to undergo PET/MRI
  • Participants with contraindications to GBCA will be asked to undergo research imaging without the use of contrast. Contraindications may be severe kidney disease or previously documented GFR \< 30 ml/min/1.73 m2

The study team makes the final eligibility decision.

Where it's taking place

  • Madison, Wisconsin, 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 - 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 Madison, Wisconsin, United States. 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.