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

NCT ID: NCT05003427

Last Updated: 2022-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2022-12-01

Brief Summary

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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

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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.

Conditions

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Oral Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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68Ga-FAPI-04 PET/CT

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.

Group Type EXPERIMENTAL

68Ga-FAPI-04

Intervention Type DRUG

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

Interventions

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68Ga-FAPI-04

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Rongxi Wang

Role: CONTACT

+8619800370331

Zhaohui Zhu, MD

Role: CONTACT

13611093752

Facility Contacts

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Rongxi Wang

Role: primary

+8619800370331

Other Identifiers

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PekingUMCH-OralFAP

Identifier Type: -

Identifier Source: org_study_id

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