NCT05749302

Brief Summary

This is an open-label whole-body PET/CT study for investigating the value of Al18F-NOTA-FAPI PET/CT in patients with malignant tumors expressing fibroblast-activated proteins

Trial Health

57
Monitor

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 phase_2

Timeline
Completed

Started Jan 2023

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 19, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2026

Completed
Last Updated

March 29, 2024

Status Verified

March 1, 2024

Enrollment Period

2.2 years

First QC Date

February 19, 2023

Last Update Submit

March 28, 2024

Conditions

Malignancy

Keywords

malignant tumors expressing fibroblast-activated proteins

Outcome Measures

Primary Outcomes (1)

  • Diagnostic value

    Sensitivity and Specificity of Al18F-NOTA-FAPI PET/CT for Malignant Tumors Expressing Fibroblast-activated Proteins

    through study completion, an average of 1 year

Study Arms (1)

Al18F-NOTA-FAPI PET/CT

EXPERIMENTAL

Al18F-NOTA-FAPI PET/CT will be performed on patients with suspected or clearly diagnosed FAP positive-expressing tumors. The patients were injected with Al18F-NOTA-FAPI and underwent PET/CT scan 20\~40min after the injection.

Drug: Al18F-NOTA-FAPI

Interventions

Al18F-NOTA-FAPIDRUG

Al18F-NOTA-FAPI was injected into the patients before the PET/CT scans

Also known as: 18F-FAPI
Al18F-NOTA-FAPI PET/CT

Eligibility Criteria

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

You may qualify if:

  • Patients with suspected or clearly diagnosed Malignant Tumors Expressing Fibroblast-activated Proteins
  • signed written consent.
  • Willing and able to cooperate with all projects in this study.

You may not qualify if:

  • pregnancy;
  • breastfeeding;
  • any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Chao Yang, 100021, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Rong Zheng, M.D.

    National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and PUMC

    STUDY DIRECTOR

Central Study Contacts

Gouzhu Hou, M.D.

CONTACT

1561114565615611145656@163.com

Xin Cheng, M.D.

CONTACT

15120002998cxpumc@foxmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2023

First Posted

March 1, 2023

Study Start

January 8, 2023

Primary Completion

March 8, 2025

Study Completion

January 8, 2026

Last Updated

March 29, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)