NCT05003427

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 12, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

October 28, 2022

Status Verified

October 1, 2022

Enrollment Period

1.7 years

First QC Date

August 6, 2021

Last Update Submit

October 26, 2022

Conditions

Oral Carcinoma

Keywords

PET/CTFAPI

Outcome Measures

Primary Outcomes (2)

  • Diagnostic performance1

    comparing the SUV and number of Oral cancer or metastasis detected by 68Ga-FAPI-04 and 18F-FDG PET/CT

    1 year

  • Diagnostic performance2

    comparing the SUV and number of Oral cancer or metastasis detected by 68Ga-FAPI-04 and 18F-FDG PET/CT

    1 year

Study Arms (1)

68Ga-FAPI-04 PET/CT

EXPERIMENTAL

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.

Drug: 68Ga-FAPI-04

Interventions

68Ga-FAPI-04DRUG

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

68Ga-FAPI-04 PET/CT

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Mouth Neoplasms

Interventions

68Ga-FAPI

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic Diseases

Central Study Contacts

Rongxi Wang

CONTACT

+8619800370331pumch_jacobwong@163.com

Zhaohui Zhu, MD

CONTACT

1361109375213611093752@163.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2021

First Posted

August 12, 2021

Study Start

April 1, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

October 28, 2022

Record last verified: 2022-10

Locations

CN(1)