FAPI-74 PET/CT in Adults with Fibrosis

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.

Conditions

Fibrosis (Morphologic Abnormality)

Study Overview

Study Details

Study overview

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.

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

FAPI-74 PET/CT in Adults with Fibrosis

Condition
Fibrosis (Morphologic Abnormality)
Intervention / Treatment

-

Contacts and Locations

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Abramson Cancer Center at Penn Medicine,

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

Study Record Dates

2027-07-30