NCT05420558

Brief Summary

The purpose of this single center prospective study is to assess the value of FAPI PET imaging in predicting early postoperative recurrence of malignant tumor of digestive system and to evaluate the diagnostic performance of FAPI PET/CT in the detection of primary tumor and metastatic lesions.

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 Jun 2022

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

First Submitted

Initial submission to the registry

June 10, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 15, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

June 23, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

July 17, 2023

Status Verified

July 1, 2023

Enrollment Period

1.5 years

First QC Date

June 10, 2022

Last Update Submit

July 13, 2023

Conditions

Gastrointestinal Cancer

Keywords

fibroblast activation protein inhibitorpositron emission tomographygastrointestinal cancerdigestive system tumorrecurrencemetastasesprognosis

Outcome Measures

Primary Outcomes (1)

  • early postoperative recurrence

    Evaluation of the value of FAPI PET imaging in predicting early postoperative recurrence of malignant tumor of digestive system

    two years

Secondary Outcomes (1)

  • diagnostic performance

    18 months

Interventions

Fibroblast activation protein inhibitor PET/CT imagingDIAGNOSTIC_TEST

All participants will receive a 68Ga-labelled fibroblast activation protein inhibitor PET/CT imaging

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with suspected or new diagnosed gastrointestinal cancer or other malignant tumor of digestive system.

You may qualify if:

  • Voluntarily participate and sign the informed consent.
  • Patients with suspected or new diagnosed gastrointestinal cancer or other malignant tumor of digestive system.
  • Complete clinical information, biochemical examination results, CT and/or MRI imaging examination, pathological information, and clinical/imaging follow-up data.

You may not qualify if:

  • Female patient who plan to become pregnant within 6 months, or pregnant or breast-feeding women.
  • Allergic constitution.
  • Those who are in poor general condition and cannot tolerate PET/CT examination.
  • The researchers believe that he or she is not suitable to participate in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

RECRUITING

Related Publications (3)

  • Lin R, Lin Z, Chen Z, Zheng S, Zhang J, Zang J, Miao W. [68Ga]Ga-DOTA-FAPI-04 PET/CT in the evaluation of gastric cancer: comparison with [18F]FDG PET/CT. Eur J Nucl Med Mol Imaging. 2022 Jul;49(8):2960-2971. doi: 10.1007/s00259-022-05799-5. Epub 2022 Apr 25.

    PMID: 35462566BACKGROUND

  • Fu L, Huang S, Wu H, Dong Y, Xie F, Wu R, Zhou K, Tang G, Zhou W. Superiority of [68Ga]Ga-FAPI-04/[18F]FAPI-42 PET/CT to [18F]FDG PET/CT in delineating the primary tumor and peritoneal metastasis in initial gastric cancer. Eur Radiol. 2022 Sep;32(9):6281-6290. doi: 10.1007/s00330-022-08743-1. Epub 2022 Apr 5.

    PMID: 35380229BACKGROUND

  • Qin C, Song Y, Gai Y, Ruan W, Liu Q, Liu F, Zheng D, Zhang P, Liu H, Zhang T, Tao K, Lan X. Gallium-68-labeled fibroblast activation protein inhibitor PET in gastrointestinal cancer: insights into diagnosis and management. Eur J Nucl Med Mol Imaging. 2022 Oct;49(12):4228-4240. doi: 10.1007/s00259-022-05847-0. Epub 2022 Jun 3.

    PMID: 35657428BACKGROUND

MeSH Terms

Conditions

Gastrointestinal NeoplasmsDigestive System NeoplasmsRecurrenceNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplastic Processes

Study Officials

  • Chongjiao Li, MD, PhD

    Wuhan University

    STUDY DIRECTOR

Central Study Contacts

Chongjiao Li, MD, PhD

CONTACT

+86-18827093900LCJ0301@163.com

Yong He, MD, PhD

CONTACT

+86-27-67812698vincentheyong@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2022

First Posted

June 15, 2022

Study Start

June 23, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

July 17, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

The individual participant data will not be shared with other researchers. Our research results will eventually be shared with other researchers in the form of paper.

Locations

CN(1)