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

Status

UNKNOWN

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05003427

Enrollment

Registered

2021-08-12

Start date

2021-04-01

Completion date

2022-12-01

Last updated

2022-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Carcinoma

Keywords

PET/CT, FAPI

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.

Interventions

DRUG68Ga-FAPI-04

68Ga-FAPI-04 were injected into the patients before the PET/CT scans

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

China

Contacts

Primary ContactRongxi Wang

pumch_jacobwong@163.com+8619800370331

Backup ContactZhaohui Zhu, MD

13611093752@163.com13611093752

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026