Multimodal PET Imaging in the Diagnosis and Treatment of Pelvic Tumors

January 12, 2025 updated by: Peking Union Medical College Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

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 Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: imaging examinations
The study recruited patients suffering from endometrial cancer, and three types of examinations will be performed on them.
Diagnostic test: three kinds of examinations
Following the enrollment of patients, both Gallium-68 labeled Fibroblast Activation Protein Inhibitor-04 Positron Emission Tomography/Computed Tomography (68Ga-FAPI-04 PET/CT) and Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI) scans are carried out. Additionally, within a one-week interval before and after the aforementioned examinations, Fluorine-18 labeled Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (18F-FDG PET/CT) is performed on the same cohort of patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lymph Node Metastasis FAPI Uptake (SUVmax) and Distant Metastasis FAPI Uptake (SUVmax)
Time Frame: Through study completion, an average of 1 year

Lymph Node Metastasis FAPI Uptake (SUVmax): This measures how much FAPI the lymph nodes that might have cancer spread to are taking up, using FAPI PET/CT scans. This helps us understand how active the cancer in the lymph nodes is.

Distant Metastasis FAPI Uptake (SUVmax): This checks how much FAPI other cancer spots far from the lymph nodes are taking up. It helps us figure out how far the cancer has spread and how aggressive it is.
Through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Peking Union Medical College Hospital

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)

March 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

October 17, 2024

First Submitted That Met QC Criteria

January 12, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 12, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMCH-NM-Pelvic Tumors-FAPI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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