Multimodal PET Imaging in the Diagnosis and Treatment of Pelvic Tumors

NCT ID: NCT06774209

Last Updated: 2025-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Endometrial Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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imaging examinations

The study recruited patients suffering from endometrial cancer, and three types of examinations will be performed on them.

Group Type EXPERIMENTAL

three kinds of examinations

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhaoxia huang, B.S.

Role: CONTACT

86+18929673449

Facility Contacts

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Zhaoxia Huang,M.D.

Role: primary

86+18929673449

Other Identifiers

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PUMCH-NM-Pelvic Tumors-FAPI

Identifier Type: -

Identifier Source: org_study_id

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