NCT06094530

Brief Summary

The clinical feasibility of 18F-FAPI-RGD PET/CT will be evaluated in 100 patients with various types of tumor, and the results will be compared with those of 18F-FDG.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

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 10, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

1.4 years

First QC Date

October 16, 2023

Last Update Submit

October 16, 2023

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Comparison of 18F-FAPI-RGD and 18F-FDG Uptake in Patients with different Tumors

    Tracer uptake in normal organs (background) is quantified by SUVmean, which is delineated with a sphere that had a diameter of 1 cm (for small organs, including thyroid, salivary gland, and pancreas) to 2 cm(for other organs, including brain, heart, liver, kidney, spleen, muscle, and bone marrow) placed inside the organ parenchyma. The tumor-to background ratio (TBR) is calculated as tumor SUVmax/background SUVmean.

    1 month

Eligibility Criteria

Age10 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with clinically suspected or diagnosed tumors

You may qualify if:

  • Patients with clinically suspected or diagnosed tumors

You may not qualify if:

  • Hypertension that is difficult to control with medication, and systolic blood pressure exceeding 160mmHg
  • Complicated with chronic liver disease, myocardial infarction, stroke
  • Female patients who are pregnant (or attempting to become pregnant within six months), breastfeeding, or unwilling to use contraception
  • Abnormal cardiopulmonary function or mental state, unable to tolerate prone lying for 20 minutes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departments of Nuclear Medicine, Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Hao Wang, Doctor

    Sichuan Provincial People's Hospital

    STUDY DIRECTOR

Central Study Contacts

Hao Wang, Doctor

CONTACT

+86-18313820216474556259@qq.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate senior physician

Study Record Dates

First Submitted

October 16, 2023

First Posted

October 23, 2023

Study Start

April 10, 2023

Primary Completion

September 1, 2024

Study Completion

October 1, 2024

Last Updated

October 23, 2023

Record last verified: 2023-10

Locations

CN(1)