NCT05810324

Brief Summary

To evaluate the potential usefulness of 18F-FAPI positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer.

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
500

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Jul 2022

Typical duration for not_applicable cancer

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

July 1, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 12, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

April 12, 2023

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

March 30, 2023

Last Update Submit

March 30, 2023

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy

    The sensitivity, specificity and accuracy of 18F-FAPI PET/CT were calculated.

    1 year

Study Arms (1)

18F-FAPI

EXPERIMENTAL

Experimental: Experimental: 18F-FAPI Each subject receive a single intravenous injection of 18F-FAPI, and undergo PET/CT imaging within the specificed time.

Drug: 18F-FAPI

Interventions

18F-FAPIDRUG

Each patient receive a single intravenous injection of 18F-FAPI, and undergo PET/CT scan within specified time.

Also known as: FAPI
18F-FAPI

Eligibility Criteria

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

You may qualify if:

  • patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report);
  • patients who had scheduled 18F-FAPI PET/CT scan; (iv)
  • patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

You may not qualify if:

  • patients with non-malignant lesions;
  • patients with pregnancy;
  • the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China-Japan Union Hospital

Changchun, Jilin, 130031, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Bin Ji

    China-Japan Union Hospital, Jilin University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shi Gao

CONTACT

+86-0431-84995467Gaoshi@jlu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

March 30, 2023

First Posted

April 12, 2023

Study Start

July 1, 2022

Primary Completion

July 1, 2024

Study Completion

January 1, 2025

Last Updated

April 12, 2023

Record last verified: 2023-03

Locations

CN(1)