RECRUITING

FAPI-74 PET/CT in Adults with Fibrosis

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This protocol is intended as a basket protocol designed to evaluate the use of Fibroblast Activating Protein (FAP) PET/CT in imaging the presence of fibrosis caused by a variety of medical conditions where fibrosis is believed to lead to pathological effects and poor prognosis.

Official Title

Fibroblast Activating Protein (FAP) PET/CT in Adults with Fibrotic Conditions

Quick Facts

Study Start:2024-07-16

Study Completion:2027-07-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06413355

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Participants will be ≥ 21 years of age 2. Diagnosis of oropharyngeal squamous cell carcinoma (OPSCC) 3. Determined to be surgical candidates 1. Participants will be ≥ 21 years of age 2. Diagnosed with microbiologically confirmed DS-pTB (culture positive) 3. Completed DS-pTB treatment according to IDSA guidelines in the past 3 months to 2 years 4. Negative test for sputum Mtb culture at least two consecutive times during TB treatment without a subsequent positive Mtb culture (indicating cure as per CDC guidelines) 1. History of known or suspected fibrosis-inducing medical condition 2. Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.	1. Participant is not eligible for tissue resection 1. Diagnosed with TB that is resistant to rifampin 2. History of alternative pulmonary disease 3. Have been administered corticosteroids or any other systemic investigational agents within 3 months of screening 4. Have symptoms or signs suggestive of active TB at the time of screening 1. Women of childbearing potential may not be pregnant or breastfeeding. A negative pregnancy test will be required before \[F-18\]- FAPI-74injection. 2. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician 3. Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study 4. Treatment with a therapeutic agent targeting fibroblast activation protein (FAP) within 1 month prior to study enrollment.

Inclusion Criteria

Exclusion Criteria

1. Participants will be ≥ 21 years of age
2. Diagnosis of oropharyngeal squamous cell carcinoma (OPSCC)
3. Determined to be surgical candidates
1. Participants will be ≥ 21 years of age
2. Diagnosed with microbiologically confirmed DS-pTB (culture positive)
3. Completed DS-pTB treatment according to IDSA guidelines in the past 3 months to 2 years
4. Negative test for sputum Mtb culture at least two consecutive times during TB treatment without a subsequent positive Mtb culture (indicating cure as per CDC guidelines)
1. History of known or suspected fibrosis-inducing medical condition
2. Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.

1. Participant is not eligible for tissue resection
1. Diagnosed with TB that is resistant to rifampin
2. History of alternative pulmonary disease
3. Have been administered corticosteroids or any other systemic investigational agents within 3 months of screening
4. Have symptoms or signs suggestive of active TB at the time of screening
1. Women of childbearing potential may not be pregnant or breastfeeding. A negative pregnancy test will be required before \[F-18\]- FAPI-74injection.
2. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
3. Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
4. Treatment with a therapeutic agent targeting fibroblast activation protein (FAP) within 1 month prior to study enrollment.

Contacts and Locations

Study Contact

Erin Schubert

CONTACT

215-573-6569

erinschu@pennmedicine.upenn.edu

Mary Hansbury

CONTACT

215-746-8192

mary.hansbury@pennmedicine.upenn.edu

Principal Investigator

Mark A Sellmyer, MD, PhD

PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Study Locations (Sites)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: Abramson Cancer Center at Penn Medicine

Mark A Sellmyer, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-16

Study Completion Date2027-07-30

Study Record Updates

Study Start Date2024-07-16

Study Completion Date2027-07-30

Terms related to this study

Additional Relevant MeSH Terms

Fibrosis (Morphologic Abnormality)