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

Chinese Academy of Medical Sciences & Peking Union Medical College logo

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase

Enrolling
Early Phase 1

Conditions

Oral Carcinoma

Treatments

Drug: 68Ga-FAPI-04

Study type

Interventional

Funder types

Other

Identifiers

NCT05003427
PekingUMCH-OralFAP

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

16+ years old

Volunteers

No 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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

68Ga-FAPI-04 PET/CT
Experimental group
Description:
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.
Treatment:
Drug: 68Ga-FAPI-04

Trial contacts and locations

1

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Central trial contact

Rongxi Wang; Zhaohui Zhu, MD

Data sourced from clinicaltrials.gov

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