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68Ga-FAPI PET/CT in Malignant Tumors

NCT05034146 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2025-06-05

No results posted yet for this study

Summary

Fibroblast-activation protein (FAP) is a type Ⅱ transmembrane serine protease and is overexpressed in cancer-associated fibroblasts (CAFs). CAFs are the predominant component in the stroma of epithelial neoplasms. FAP can be detected in various of malignant neoplasms and is associated to tumor cell migration, invasion, and angiogenesis. Recently, a novel molecular probe, gallium 68-labelled FAP inhibitor (68Ga-FAPI), has been developed and used for visualization of tumor stroma by targeting FAP. Recent studies show favorable diagnosis efficiency in a variety of tumors, especially in gastrointestinal cancer, but the previous studies were all small-sample data or case reports. Therefore, further large-size research is necessary to confirm the advantages of 68Ga-FAPI in various of malignant tumors.

Conditions

  • Fibroblast Activation Protein Inhibitor
  • PET/CT
  • Malignant Neoplasm

Interventions

DRUG

68Ga-FAPI

68Ga-FAPI was injected intravenously to each subject, and the dose is calculated according to body weight of subject (approximately 1.85-3.7MBq/kg).

DEVICE

PET/CT

68Ga-FAPI PET/CT scan were performed 20\~60 min after 68Ga-FAPI (1.85-3.7MBq/kg) injection intravenously.

Sponsors & Collaborators

  • Zhongnan Hospital

    lead OTHER

Principal Investigators

  • Yong He, MD, PhD · Zhongnan Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
88 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-23
Primary Completion
2025-12-31
Completion
2025-12-31

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 NCT05034146 on ClinicalTrials.gov