NCT05499936

Brief Summary

This study was used to study the diagnostic value of 68Ga-FAPI, a novel fibroblast activating inhibitor, in metastatic adenoid cystic carcinoma（ACC）

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 below P25 for not_applicable

Timeline
Completed

Started Oct 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

October 1, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 12, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

August 12, 2022

Status Verified

October 1, 2021

Enrollment Period

1 year

First QC Date

June 28, 2022

Last Update Submit

August 10, 2022

Conditions

68Ga-FAPI PET/CTMetastatic Adenoid Cystic Carcinoma

Keywords

68Ga-FAPIPET/CTAdenoid Cystic Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Standardized uptake value of 68Ga-FAPI in ACC

    The maximum and mean standard uptake values (SUVmax and SUVmean) were measured in the background of lesion, liver, muscle and mediastinal blood pool, respectively.

    1 year

Secondary Outcomes (1)

  • lesions detected by 68Ga-FAPI PET/CT

    1 year

Other Outcomes (1)

  • compared with 18F-FDG PET/CT or other imaging like CT and MRI

    1 year

Study Arms (1)

68Ga-FAPI PET/CT

EXPERIMENTAL

Imaging was performed 30-60 minutes after injection of 2-4mci 68Ga-FAPI tracer

Drug: 68Ga-FAPI

Interventions

68Ga-FAPIDRUG

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

68Ga-FAPI PET/CT

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with ACC suspected metastatic tumor,and 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, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Adenoid Cystic

Interventions

68Ga-FAPI

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Zhaohui Zhu

    Peking Union Medical College Hospital

    STUDY CHAIR

Central Study Contacts

Rongxi Wang

CONTACT

+8619800370331pumch_jacobwong@163.com

Zhaohui Zhu

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2022

First Posted

August 12, 2022

Study Start

October 1, 2021

Primary Completion

October 1, 2022

Study Completion

December 31, 2022

Last Updated

August 12, 2022

Record last verified: 2021-10

Locations

CN(1)