Utveckling av FAPI PET som en icke-invasiv biomarkör för lungfibrogenes
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Researchers aim to develop a non-invasive PET/MRI imaging tool using FAPI as a PET radiotracer and MRI to assess the presence and extent of fibrogenesis (the process that leads to fibrosis and scarring) in the lungs.
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 2
Kontakter och platser
Studiekontakt
- Namn: Radiology Studies
- Telefonnummer: 608-282-8349
- E-post: Radstudy@uwhealth.org
Studieorter
-
-
Wisconsin
-
Madison, Wisconsin, Förenta staterna, 53705
- Rekrytering
- University of Wisconsin - Madison
-
Huvudutredare:
- Ali Pirasteh, MD
-
Kontakt:
- Stephanie Wilson
- E-post: SWilson8@uwhealth.org
-
Underutredare:
- Julius Heidenreich, MD
-
Underutredare:
- Nathan Sandbo, MD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
-
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 setting of fibrotic hypersensitivity pneumonitis (HSP) or idiopathic pulmonary fibrosis (IPF), per standard of clinical care at UW Health.
-
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 treatment) in the setting of fibrotic hypersensitivity pneu-monitis (HSP) or idiopathic pulmonary fibrosis (IPF), per standard of clinical care at UW Health.
-
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 addition of new treatment (to any current treatment) in the setting of fibrotic hypersensitivity pneumonitis (HSP) or idiopathic pulmonary fibrosis (IPF), per standard of clinical care at UW Health.
-
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 criteria are met:
- 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
Exclusion Criteria:
- 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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Group A - 3 scans
Participants undergo three PET/MRI scans using the FAPI radiotracer. They will have 3 research visits, and each visit may last up to 2.5 hours. |
radioactive substance called a "tracer" injected into the arm positron emission tomography (PET) takes pictures of inside of the body |
|
Experimentell: Group B - 2 scans
Participants undergo two PET/MRI scans using the FAPI radiotracer. They will have 2 research visits, and each visit may last up to 2.5 hours. |
radioactive substance called a "tracer" injected into the arm positron emission tomography (PET) takes pictures of inside of the body |
|
Experimentell: Group B Crossover
Participants undergo two additional PET/MRI scans using the FAPI radiotracer. They will have 2 additional research visits, and each visit may last up to 2.5 hours. |
radioactive substance called a "tracer" injected into the arm positron emission tomography (PET) takes pictures of inside of the body |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in FAPI uptake
Tidsram: Baseline to 6 months
|
FAPI uptake of fibrotic lesions as measured by Standardized Uptake Value (SUV). SUV quantifies the tracer uptake, helping to differentiate between normal and abnormal tissues and assess the extent of tumor activity. |
Baseline to 6 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Ali Pirasteh, MD, University of Wisconsin, Madison
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2025-0489
- A539300 (Annan identifierare: UW Madison)
- SMPH/RADIOLOGY/RADIOLOGY (Annan identifierare: UW Madison)
- Protocol Version 2/5/26 (Annan identifierare: UW Madison)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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