Fibroblast Activation Protein Inhibitor PET/CT Imaging in Malignant Tumor of Digestive System

July 13, 2023 updated by: Zhongnan Hospital

The Application of Molecular Probe Targeting Fibroblast Activation Protein in Malignant Tumor of Digestive System

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Malignant tumor of digestive system is one of the most common cancer types worldwide with high cancer-related mortalities. FDG PET/CT is an essential imaging modality in the tumor treatment and management. However, FDG PET/CT has certain limitations. For example, the detection sensitivity and tracer uptake in signet ring cell carcinoma (SRCC) is low. Furthermore, the physiological uptake of the gastrointestinal tract and acute gastroenteritis may mask the detection of lesion in the abdomen and pelvis. Therefore, a novel molecular imaging tracer is needed for the accurate evaluation of malignant tumor of digestive system.

Cancer-associated fibroblasts (CAFs) specifically express fibroblast activation protein (FAP), which is highly expressed by CAFs in more than 90% of human epithelial cancers. FAP-specific small molecule inhibitors (FAPIs) show much advantages over FDG, including high tumor accumulation, low background tissue uptake, and rapid clearance in vivo.

The purpose of this single center prospective study is to assess the value of FAPI PET/CT 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.

In this study, qualitative and quantitative analyses will be used. The diagnostic criteria of FAPI PET/CT: if the FAPI uptake of lesion is higher than that of the surrounding background tissue, it is determined as a positive lesion; if the FAPI uptake of the lesion is the same as or lower than that of the surrounding background tissue, it is determined as a negative lesion. Pathological result is used as the gold standard for diagnosis. The diagnostic performance of FAPI PET/CT including sensitivity, specificity, positive predictive value, negative predictive value, and accuracy will be calculated.

The quantitative indicators include the following metabolic parameters: maximum standard uptake value (SUVmax), mean standard uptake value (SUVmean), tumor metabolic volume (MTV), total tumor glycolysis (TLG), tumor-to-liver ratio, and tumor-to-background tissue ratio.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Chongjiao Li, MD, PhD
  • Phone Number: +86-18827093900
  • Email: LCJ0301@163.com

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430071
        • Recruiting
        • Zhongnan Hospital Of Wuhan University
        • Contact:
          • Chongjiao Li
          • Phone Number: +86-27-67812698

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
early postoperative recurrence
Time Frame: two years
Evaluation of the value of FAPI PET imaging in predicting early postoperative recurrence of malignant tumor of digestive system
two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
diagnostic performance
Time Frame: 18 months
Evaluation of the diagnostic performance of FAPI PET imaging in detecting malignant tumor of digestive system
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongnan Hospital

Investigators

  • Study Director: Chongjiao Li, MD, PhD, Wuhan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2022

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

June 10, 2022

First Submitted That Met QC Criteria

June 10, 2022

First Posted (Actual)

June 15, 2022

Study Record Updates

Last Update Posted (Actual)

July 17, 2023

Last Update Submitted That Met QC Criteria

July 13, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZNYYPTXM2022013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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