Développement du PET FAPI comme biomarqueur non invasif de la fibrogenèse pulmonaire
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- Phase 2
Contacts et emplacements
Coordonnées de l'étude
- Nom: Radiology Studies
- Numéro de téléphone: 608-282-8349
- E-mail: Radstudy@uwhealth.org
Lieux d'étude
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Wisconsin
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Madison, Wisconsin, États-Unis, 53705
- Recrutement
- University of Wisconsin - Madison
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Chercheur principal:
- Ali Pirasteh, MD
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Contact:
- Stephanie Wilson
- E-mail: SWilson8@uwhealth.org
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Sous-enquêteur:
- Julius Heidenreich, MD
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Sous-enquêteur:
- Nathan Sandbo, MD
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
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Age 18 years or older
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Able and willing to provide informed consent
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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.
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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.
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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.
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Willing and able to undergo PET/MRI.
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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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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 |
|
Expérimental: 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 |
|
Expérimental: 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 |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in FAPI uptake
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Ali Pirasteh, MD, University of Wisconsin, Madison
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2025-0489
- A539300 (Autre identifiant: UW Madison)
- SMPH/RADIOLOGY/RADIOLOGY (Autre identifiant: UW Madison)
- Protocol Version 2/5/26 (Autre identifiant: UW Madison)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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