## Protocol Section
### Identification Module
**NCT ID:** NCT06438250

**Brief Title:** 68Ga-FAPI-JH04 PET/CT: Dosimetry and Biodistribution Studies

**Official Title:** 68Ga-FAPI-JH04 PET/CT: Dosimetry and Biodistribution Study in Patients With Various Cancers

#### Organization Study ID Info
**ID:** FirstAHFujian-68Ga-FAPI-JH04
#### Organization
**Class:** OTHER
**Full Name:** First Affiliated Hospital of Fujian Medical University
### Status Module
#### Completion Date
**Date:** 2024-07-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-27

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-06-10

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-03-01

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** First Affiliated Hospital of Fujian Medical University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** 68Ga-FAPI-JH04 is a novel radiotracer targeting fibroblast activation protein (FAP). In this study, we observed the safety, biodistribution, and radiation dosimetry of 68Ga-JH040182 in patients with different types of cancer.

**Detailed Description:** Carcinoma-associated fibroblasts (CAFs) are an integral part of the tumor microenvironment, and fibroblast activation protein (FAP), as a specific marker of CAFs, is overexpressed in more than 90% of epithelial malignant tumors' CAFs, with limited expression in normal tissues, making it an appropriate target for various tumors. Currently, several tracers targeting FAP for diagnostic purposes have been developed, such as 68Ga-FAPI-04, 68Ga-FAPI-02, and showed high efficacy in tumor staging and restaging. 68Ga-FAPI-JH04, a novel radiopharmaceutical targeting FAP, demostrated high stability in vitro and in vivo, and can accumulate specifically in tumors with high binding affinity, safety, and selectivity in preclinical studies. In this study, the safety, biodistribution, and radiation dosimetry of 68Ga-FAPI-JH04 in patients with different types of cancer were observed to evaluate the dosimetric characteristics of 68Ga-FAPI-JH04.

### Conditions Module

**Conditions:**

- Malignant Neoplasm

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** Drug: 68Ga-FAPI-JH04

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 5

**Type:** ESTIMATED

**Phases:**

- EARLY_PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** PET imaging will begin at 3 min (30s/bed), 15min (1min/bed), 30min (2 min/bed), 60min (2 min/bed) and 150min (2 min/bed) after injection

**Intervention Names:**

- Drug: 68Ga-FAPI-JH04

**Label:** dynamic PET scans

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- dynamic PET scans

**Description:** The dose will be 148-222 MBq given intravenously.

**Name:** 68Ga-FAPI-JH04

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** The safety evaluation of 68Ga-FAPI-JH04 PET/CT was performed for all patients based on the Common Toxicity Criteria for Adverse Events 5.0 (CTCAE 5.0) from baseline to follow up, including vital signs, health conditions, and laboratory tests.

**Measure:** safety and tolerability

**Time Frame:** Up to 1 week

#### Secondary Outcomes

**Description:** reported as relative uptake values per organ at 3min, 15min, 30min, 60min and 150 min per individual subject and as a mean over all subjects

**Measure:** Human biodistribution

**Time Frame:** From right after tracer injection to 150 min at post-injection

**Description:** radiation dose to individual organs and the equivalent dose for the whole body of each subject and as a mean over all subjects. Dosimetry will be calculated using the Hybrid-Dosimetry software.

**Measure:** Human dosimetry

**Time Frame:** From right after tracer injection to 150 min at post-injection

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Various solid tumors with available histopathological findings
* Signed informed consent

Exclusion Criteria:

* pregnant or lactational women
* who suffered from severe hepatic and renal insufficiency

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** miaoweibing@126.com

**Name:** Weibing Miao, MD

**Phone:** +86-0591-87981618

**Role:** CONTACT

**Contact 2:**

**Email:** guochang1007@163.com

**Name:** Guochang Wang, PhD

**Phone:** +86-0591-87981619

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Fuzhou

**Contacts:**

***Contact 1:***

- **Email:** miaoweibing@126.com

- **Name:** Weibing Miao, MD

- **Phone:** +86 591 87981618

- **Role:** CONTACT

***Contact 2:***

- **Email:** guochang1007@163.com

- **Name:** Guochang Wang, MD

- **Phone:** +86 591 87981619

- **Role:** CONTACT

**Country:** China

**Facility:** Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University

**State:** Fujian

**Status:** RECRUITING

**Zip:** 350005

#### Overall Officials

**Official 1:**

**Affiliation:** The First Affiliated Hospital, Fujian Medical University

**Name:** Weibing Miao, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Meshes

- ID: D000009369

- Term: Neoplasms

### Misc Info Module

- Version Holder: 2024-05-31
