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Multimodal PET Imaging in the Diagnosis and Treatment of Pelvic Tumors

Multimodal PET Imaging in the Diagnosis and Treatment of Pelvic Tumors

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06774209
Enrollment
30
Registered
2025-01-14
Start date
2024-03-01
Completion date
2025-10-01
Last updated
2025-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Cancer

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.

Interventions

DIAGNOSTIC_TESTthree 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.

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
tumor size and SUVmaxThrough study completion, an average of 1 yeartumor 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

MeasureTime frameDescription
Lymph Node Metastasis FAPI Uptake (SUVmax) and Distant Metastasis FAPI Uptake (SUVmax)Through study completion, an average of 1 yearLymph 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.

Countries

China

Contacts

Primary ContactZhaoxia huang, B.S.
1261152761@qq.com86+18929673449

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026