## Protocol Section
### Identification Module
**NCT ID:** NCT06413355

**Brief Title:** FAPI-74 PET/CT in Adults With Fibrosis

**Official Title:** Fibroblast Activating Protein (FAP) PET/CT in Adults With Fibrotic Conditions

#### Organization Study ID Info
**ID:** 19923
#### Organization
**Class:** OTHER
**Full Name:** Abramson Cancer Center at Penn Medicine
### Status Module
#### Completion Date
**Date:** 2027-05-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-09

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-05-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-30

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Abramson Cancer Center at Penn Medicine

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** 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.

**Detailed Description:** A study to evaluate subjects with fibrosis-inducing medical conditions that are known or suspected to cause tissue fibrosis (e.g. cancer-associated, post-infection, post-radiation, pre or post-transplant, cardiac, liver, kidney or pulmonary fibrosis). This protocol is intended to expand as needed with imaging arms designed to evaluate the use of Fibroblast Activating Protein (FAP) PET/ CT in imaging the presence fibrosis caused by medical conditions where fibrosis is believed to lead to pathological effects and poor prognosis.

\[18F\]-FAPI-74 is a positron emitting radiolabeled FAP inhibitor that will be used with a positron emission tomography/computed tomography (PET/CT) scan that will be completed in each subject who has a clinical suspicion of fibrotic disease.

PET/CT imaging will be used to evaluate the distribution of fibroblast activating protein (FAP) in major organs and other tissues affected with fibrotic diseases or conditions. This is an observational study in that \[F-18\]-FAPI-74 PET/CT will not be used to direct treatment decisions. While patients and referring physicians will not be blinded to the \[F-18\]-FAPI-74 PET/CT results, any medical or treatment decisions related to their underlying clinical diagnosis will be made by the treating physicians based upon clinical criteria.

After injection of \[F-18\]-FAPI-74, patients will undergo a vertex to mid-thigh scan, starting at approximately 60 minutes post injection. PET/CT imaging sessions will include an injection of approximately 8.0 mCi (expected range of doses is expected to be 6.0-8.0 mCi) of \[F-18\]-FAPI-74 intravenously. Data will be collected to evaluate uptake of \[F-18\]-FAPI-74 in sites of suspected fibrosis and in major organs.

An optional second PET/CT using \[F-18\]-FAPI-74 can be considered at the request of the investigators at any clinically relevant time point. This second scan may be used to quantify the changes in fibrosis over time as part of the natural progression of the fibrotic condition, or to observe changes in \[F-18\]- FAPI-74 uptake in response to therapeutic interventions.

### Conditions Module

**Conditions:**

- Fibrosis (Morphologic Abnormality)

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 25

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Head and neck cancer (up to 5 subjects), post tubercular lung disease (PTLD, up to 10 subjects) and exploratory (up to 10 subjects) with fibrosis-inducing medical conditions that are known or suspected to cause tissue fibrosis (e.g. cancer-associated, postinfection, post-radiation, pre/post-transplant, cardiac, liver, kidney or pulmonary fibrosis).

**Intervention Names:**

- Drug: [F-18]-FAPI-74

**Label:** FAPI-74 PET/CT Scan

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- FAPI-74 PET/CT Scan

**Description:** A positron-emitting radiopharmaceutical that has been studied in animals for selective measurement of the in vivo expression of FAP with positron emission tomography (PET/CT).

**Name:** [F-18]-FAPI-74

**Other Names:**

- [18F] aluminium fluorine ((S)-2,2'(7- (2-(4-(3-(4-(2-(2- cyanopyrrolidin-1-yl)-2 oxoethylcarbamoyl)quinolin-6-yloxy) propyl)piperazin-1-yl)-2-oxoethyl)-1,4,7- triazonane-1,4-diyl)diacetic acid

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** The overall quality of the generated images will be evaluated. Initial imaging of the vertex to mid-thigh will be used to investigate regional tracer uptake in suspected sites of fibrosis and normal tissues for this novel radiotracer. Uptake and retention of \[F-18\]-FAPI-74 in known or suspected sites of fibrotic disease will be evaluated visually by trained radiology readers, the principal investigator, or designee. A number of analysis methods may be tested to identify the optimal method for analyses for future studies with this radiotracer. \[F-18\]-FAPI-74 PET/CT scans will be interpreted both qualitatively and quantitatively.

**Measure:** Overall FAPI-74 PET/CT Image Analysis

**Time Frame:** 3 years

**Description:** \[18F\]-FAPi74 PET/CT data: Areas of uptake in tumors and healthy tissue will be measured by SUVmax and semiquantitative analysis will be conducted. In each case, lesion uptake will be marked as low, medium, and high avidity. Each lesion and lymph node will be separately measured and quantified. Measurements will be made by Dr. Sellmyer and co-Investigators (n=3).

**Measure:** Head and Neck Cancer FAPI-74 PET/CT Image Analysis

**Time Frame:** 3 years

**Description:** Quantitative interpretation of FAP expression, will be recorded as a Standardized Uptake Value (SUV). Max, mean, and peak SUV values will be recorded for a region-of-interest encompassing a single primary lesion.

**Measure:** PTLD FAPI-74 PET/CT Image Analysis

**Time Frame:** 3 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

Head and Neck Cancer Cohort:

1. Participants will be ≥ 21 years of age
2. Diagnosis of oropharyngeal squamous cell carcinoma (OPSCC)
3. Determined to be surgical candidates

PTLD Cohort:

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)

All Cohorts:

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.

Exclusion Criteria:

Head and Neck Cancer Cohort:

1. Participant is not eligible for tissue resection

PTLD Cohort:

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

All Cohorts:

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.

**Minimum Age:** 21 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** erinschu@pennmedicine.upenn.edu

**Name:** Erin Schubert

**Phone:** 215-573-6569

**Role:** CONTACT

**Contact 2:**

**Email:** mary.hansbury@pennmedicine.upenn.edu

**Name:** Mary Hansbury

**Phone:** 215-746-8192

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Philadelphia

**Contacts:**

***Contact 1:***

- **Email:** erinshu@pennmedicine.upenn.edu

- **Name:** Erin Schubert

- **Phone:** 215-573-6569

- **Role:** CONTACT

***Contact 2:***

- **Email:** mark.sellymer@pennmedicine.upenn.edu

- **Name:** Mark A Sellymer, MD, PhD

- **Role:** CONTACT

***Contact 3:***

- **Name:** Mark A Sellmyer, MD, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** University of Pennsylvania

**State:** Pennsylvania

**Zip:** 19104

#### Overall Officials

**Official 1:**

**Affiliation:** University of Pennsylvania

**Name:** Mark A Sellmyer, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M12

- Name: Congenital Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M8485

- Name: Fibrosis

- Relevance: HIGH

- As Found: Fibrosis

### Condition Browse Module - Meshes

- ID: D000005355

- Term: Fibrosis

### Intervention Browse Module - Ancestors

- ID: D000000969

- Term: Antinematodal Agents

- ID: D000000871

- Term: Anthelmintics

- ID: D000000977

- Term: Antiparasitic Agents

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000050257

- Term: Tubulin Modulators

- ID: D000050256

- Term: Antimitotic Agents

- ID: D000050258

- Term: Mitosis Modulators

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000004791

- Term: Enzyme Inhibitors

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: AnCoag

- Name: Anticoagulants

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M8587

- Name: Fluorides

- Relevance: LOW

- As Found: Unknown

- ID: M1815

- Name: Piperazine

- Relevance: HIGH

- As Found: Prevnar 13™

- ID: M11446

- Name: Mebendazole

- Relevance: HIGH

- As Found: Prevnar 13™

- ID: M234880

- Name: Piperazine citrate

- Relevance: HIGH

- As Found: Prevnar 13™

- ID: M256301

- Name: DMP 777

- Relevance: HIGH

- As Found: Prevnar 13™

- ID: M11110

- Name: Liver Extracts

- Relevance: LOW

- As Found: Unknown

- ID: M21258

- Name: Radiopharmaceuticals

- Relevance: LOW

- As Found: Unknown

- ID: M21320

- Name: Citric Acid

- Relevance: LOW

- As Found: Unknown

- ID: M1837

- Name: Sodium Citrate

- Relevance: LOW

- As Found: Unknown

- ID: M4196

- Name: Anthelmintics

- Relevance: LOW

- As Found: Unknown

- ID: M4294

- Name: Antiparasitic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M26197

- Name: Tubulin Modulators

- Relevance: LOW

- As Found: Unknown

- ID: M26196

- Name: Antimitotic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: T382

- Name: Citrate

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000077489

- Term: Piperazine

- ID: D000008463

- Term: Mebendazole

- ID: C000006589

- Term: Piperazine citrate

- ID: C000105999

- Term: DMP 777

### Misc Info Module

- Version Holder: 2024-05-31
