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Clinical Trials/NCT06774209
NCT06774209
Recruiting
Not Applicable

Multimodal PET Imaging in the Diagnosis and Treatment of Pelvic Tumors

Peking Union Medical College Hospital1 site in 1 country30 target enrollmentMarch 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endometrial Cancer
Sponsor
Peking Union Medical College Hospital
Enrollment
30
Locations
1
Primary Endpoint
tumor size and SUVmax
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

This study is a prospective exploratory study to explore the application value of gallium 68 labeled-fibroblast activation protein inhibitor-04 Positron Emission Tomography(68Ga-FAPI-04 PET)imaging in patients with endometrial cancer and compare it with the imaging agent with better imaging effects to study its advantages. After patient enrollment, 68Ga-FAPI-04 Positron Emission Tomography/Computed Tomography(PET/CT) and Positron Emission Tomography/Magnetic Resonance Imaging(PET/MRI) examinations are performed, with the imaging agent administered intravenously at a dose of 0.02 to 0.04 mCi/Kg×patient weight (Kg), and a whole-body scan is performed 30-60 minutes later, with images processed as usual. Within 1 week before and after the examination, Fluorine18 labeled-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography(18F-FDG PET/CT) is completed, along with medical history collection and necessary laboratory tests. Subsequently, patients undergo surgical resection of the lesion and suspicious metastatic lymph nodes shown by FAPI PET/CT to obtain the corresponding pathological results. Finally, the diagnostic value of all patients in 68Ga-FAPI-04 PET/CT and PET/MR is analyzed and compared with 18F-FDG PET/CT to study the differences in diagnostic efficacy between the two.

Registry
clinicaltrials.gov
Start Date
March 1, 2024
End Date
October 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 18-70 years old
  • Obtaining written informed consent
  • Being able to accept follow-up
  • Feasible surgery or biopsy to obtain the final result

Exclusion Criteria

  • Pregnant and lactating female patients
  • Patients who are difficult to receive further diagnosis and treatment due to their severe condition
  • Any patients with contraindications to magnetic resonance imaging

Outcomes

Primary Outcomes

tumor size and SUVmax

Time Frame: Through study completion, an average of 1 year

tumor size:unit( Centimeter) Primary Tumor FAPI Uptake (SUVmax): This measures how much FAPI the primary endometrial cancer tumor takes up, using FAPI PET scans. It tells us how active the tumor cells are by comparing how much radiation the tumor tissue takes up compared to the normal tissue around it.

Secondary Outcomes

  • Lymph Node Metastasis FAPI Uptake (SUVmax) and Distant Metastasis FAPI Uptake (SUVmax)(Through study completion, an average of 1 year)

Study Sites (1)

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