68Ga-FAPI-04 PET/CT for the Detection of Oral Carcinoma

Early Phase 1

Recruiting

• Conditions: Oral Carcinoma
• Interventions: Drug: 68Ga-FAPI-04

• Registration Number: NCT05003427
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

FAPI is a fibroblast activation protein inhibitor and 68Ga-FAPI-04 is a potential new imaging agent for imaging of carcinoma. 68Ga-FAPI-04 PET/CT is helpful to clarify the benign, malignant and invasive range of the oral carcinoma, locate and qualitatively diagnose the tumor, and make early diagnosis and restaging of recurrent tumor.

Detailed Description

Sometimes, the traditional 18F-FDG PET/CT diagnosis of head and neck tumors mistakenly diagnosed inflammatory lymph nodes as metastatic lymph nodes, resulting in false positive results. Fibroblast activation protein (FAP) is a serine peptidase on the surface of tumor associated fibroblasts. It plays an important role in promoting the growth, invasion, metastasis and immunosuppression of tumor cells. FAPI is a fibroblast activation protein inhibitor and 68Ga-FAPI-04 is a potential new imaging agent for imaging of carcinoma. 68Ga-FAPI-04 PET/CT is helpful to clarify the benign, malignant and invasive range of the oral carcinoma, locate and qualitatively diagnose the tumor, and make early diagnosis and restaging of recurrent tumor.

Study Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2021-08-06
• Study First Submitted QC: 2021-08-06
• Study First Posted: 2021-08-12
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-26
• Last Update Posted: 2022-10-28
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• patients in suspicion of oral carcinoma,
• 68Ga-FAPI-04 and 18F-FDG PET/CT within 2 week;
• being able to provide basic information and sign the written informed consent form.

Exclusion Criteria

• claustrophobia,
• pregnancy,
• breastfeeding,
• kidney or liver failure,
• inability to fulfill the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-FAPI-04 PET/CT	68Ga-FAPI-04	The patients were injected with 55.5-148 MBq (1.5-4mCi) of 68Ga-FAPI-04 in one dose intravenously and underwent SPECT/CT scan 30-90 min later.

Primary Outcome Measures

Name	Time	Method
Diagnostic performance2	1 year	comparing the SUV and number of Oral cancer or metastasis detected by 68Ga-FAPI-04 and 18F-FDG PET/CT
Diagnostic performance1	1 year	comparing the SUV and number of Oral cancer or metastasis detected by 68Ga-FAPI-04 and 18F-FDG PET/CT

Trial Locations

Locations (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College; 🇨🇳 Beijing, Beijing, China