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FAP PET/CT or PET/MR Production in the Diagnosis, Staging, and Efficacy Assessment of Malignant Tumors Application

NCT06270394 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-08-13

No results posted yet for this study

Summary

This clinical trial aims to investigate the value of fibroblast activation protein PET/CT(PET/MR) in the diagnosis, staging, and evaluation of treatment outcomes in malignant tumors. The main question it aims to answer is:

Fibroblast Activation Protein PET/CT(PET/MR) whether or in which cases this assay is superior to conventional FDG examination in the diagnosis, staging, and assessment of therapeutic efficacy of malignant tumors, thinking about the reasons behind this.

Investigators will screen suitable participants among patients undergoing routine FDG examination.

* Participants will sign an informed consent form
* Undergo 68Ga-FAPI PET/CT (PET/MR) before surgery or biopsy
* Surgical resection or puncture biopsy to obtain pathologic results. Diagnosis of patients with malignant tumors at first diagnosis; clinical staging of tumors; and clinical outcomes of patients with confirmed diagnoses will be assessed after postoperative investigator follow-up.

The researchers will compare the FDG exams the participants have had to determine the effectiveness of the fibroblast activating protein test.

Conditions

  • Malignant Tumors
  • Positron-Emission Tomography

Interventions

DRUG

68Ga-Fibroblast activation protein inhibitor

Fibroblast activation protein (FAP), a type II transmembrane serine protease with dipeptidyl peptidase and endopeptidase activities. FAP is a specific surface marker for activated fibroblasts in the mesenchyme of tumors, which account for 90% of the stroma of epithelial neoplasms. FAP inhibitors (FAPIs) can specifically target and bind to FAP. These inhibitors that are radiolabeled with gallium 68 (68Ga-FAPIs) can be probes for visualization of the FAP tumor stroma. Previous studies have demonstrated that 68Ga-FAPI-04 is not dependent on blood glucose levels, has an equal or better tumor-to-background ratio, and clearly visualizes primary tumors and their metastatic foci. In addition, previous studies on 68Ga-FAPI-04 have focused on PET/CT and the efficacy of PET/MR with FAPI for postoperative evaluation of GI tumors remains to be clarified.

Sponsors & Collaborators

  • National Natural Science Foundation of China

    collaborator OTHER_GOV

  • The First Affiliated Hospital of Anhui Medical University

    lead OTHER

Principal Investigators

  • Huiqin Xu · The First Affiliated Hospital of Anhui Medical University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-28
Primary Completion
2023-11-28
Completion
2025-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06270394 on ClinicalTrials.gov