FAPI and FDG PET/MRI in Diagnosis and Therapy Prediction of Bladder Cancer

NCT ID: NCT06421142

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2026-12-31

Brief Summary

The aim of this trial is to investigate the value of FAPI PET/MRI, FDG PET/MRI and MRI in diagnosing MIBC and predicting the efficacy of neoadjuvant therapy for MIBC patients, so as to guide the clinic to adjust the treatment plan in time and benefit MIBC patients.

Detailed Description

The MIBC diagnostic study was a prospective trial. According to the inclusion and exclusion criteria, patients with suspected MIBC were enrolled and underwent FAPI PET/MRI, FDG PET/MRI and MRI examination, and the imaging data and clinical laboratory and pathologic data were collected, and the postoperative pathological results were used as the gold standard to compare the accuracy of FAPI PET/MRI, FDG PET/MRI and MRI in diagnosing MIBC.

The MIBC neoadjuvant therapy efficacy assessment study was a prospective trial. Patients with MIBC were enrolled according to the inclusion and exclusion criteria, the regimen was selected individually according to the patient's condition, and the indicators were followed up until the end of time or the occurrence of an endpoint event to obtain information on survival time. FAPI PET/MRI, FDG PET/MRI and MRI were performed once before the start of neoadjuvant therapy and once after the end of therapy, and after the end of neoadjuvant therapy, patients received transurethral cystectomy of bladder tumors or radical cystectomy according to the efficacy and condition, and the combination of the imaging data and the clinical laboratory and pathological data were used to compare FAPI PET/MRI, FDG PET/ MRI and MRI in the assessment of the efficacy of neoadjuvant therapy in MIBC patients to guide clinical treatment options.

Conditions

Urinary Bladder Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

MIBC diagnostic study-FAPI PET/MRI

suspected MIBC participants receive FAPI PET/MRI examination after entering the group.

Group Type: EXPERIMENTAL

imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI

Intervention Type: PROCEDURE

FAPI PET/MRI and FDG PET/MRI examination Data acquisition was performed using a GE Healthcare SIGNA PET/MR instrument. Enrolled patients were injected intravenously with 68Ga-FAPI or 18F-FDG tracer and underwent simultaneous PET and MRI scanning approximately 30-60 minutes after intravenous administration of the tracer at a dose of 1.85-3.7 MBq/kg.

MRI examination MRI examination was performed using a Skyra 3.0T MRI scanner from Siemens, Germany, with a 16-channel phased-array surface coil, and the scanning range was from the superior margin of the iliac wing to the inferior margin of the pubic symphysis.

MIBC diagnostic study-FDG PET/MRI

suspected MIBC participants receive FDG PET/MRI examination after entering the group.

Group Type: EXPERIMENTAL

imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI

Intervention Type: PROCEDURE

FAPI PET/MRI and FDG PET/MRI examination Data acquisition was performed using a GE Healthcare SIGNA PET/MR instrument. Enrolled patients were injected intravenously with 68Ga-FAPI or 18F-FDG tracer and underwent simultaneous PET and MRI scanning approximately 30-60 minutes after intravenous administration of the tracer at a dose of 1.85-3.7 MBq/kg.

MRI examination MRI examination was performed using a Skyra 3.0T MRI scanner from Siemens, Germany, with a 16-channel phased-array surface coil, and the scanning range was from the superior margin of the iliac wing to the inferior margin of the pubic symphysis.

MIBC diagnostic study-MRI

suspected MIBC participants receive MRI examination after entering the group.

Group Type: ACTIVE_COMPARATOR

imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI

Intervention Type: PROCEDURE

FAPI PET/MRI and FDG PET/MRI examination Data acquisition was performed using a GE Healthcare SIGNA PET/MR instrument. Enrolled patients were injected intravenously with 68Ga-FAPI or 18F-FDG tracer and underwent simultaneous PET and MRI scanning approximately 30-60 minutes after intravenous administration of the tracer at a dose of 1.85-3.7 MBq/kg.

MRI examination MRI examination was performed using a Skyra 3.0T MRI scanner from Siemens, Germany, with a 16-channel phased-array surface coil, and the scanning range was from the superior margin of the iliac wing to the inferior margin of the pubic symphysis.

MIBC neoadjuvant evaluation study-FAPI PET/MRI

Patients diagnosed with MIBC receive FAPI PET/MRI examination before and after neoadjuvant therapy.

Group Type: EXPERIMENTAL

imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI

Intervention Type: PROCEDURE

FAPI PET/MRI and FDG PET/MRI examination Data acquisition was performed using a GE Healthcare SIGNA PET/MR instrument. Enrolled patients were injected intravenously with 68Ga-FAPI or 18F-FDG tracer and underwent simultaneous PET and MRI scanning approximately 30-60 minutes after intravenous administration of the tracer at a dose of 1.85-3.7 MBq/kg.

MRI examination MRI examination was performed using a Skyra 3.0T MRI scanner from Siemens, Germany, with a 16-channel phased-array surface coil, and the scanning range was from the superior margin of the iliac wing to the inferior margin of the pubic symphysis.

MIBC neoadjuvant evaluation study-FDG PET/MRI

Patients diagnosed with MIBC receive FDG PET/MRI examination before and after neoadjuvant therapy.

Group Type: EXPERIMENTAL

imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI

Intervention Type: PROCEDURE

FAPI PET/MRI and FDG PET/MRI examination Data acquisition was performed using a GE Healthcare SIGNA PET/MR instrument. Enrolled patients were injected intravenously with 68Ga-FAPI or 18F-FDG tracer and underwent simultaneous PET and MRI scanning approximately 30-60 minutes after intravenous administration of the tracer at a dose of 1.85-3.7 MBq/kg.

MRI examination MRI examination was performed using a Skyra 3.0T MRI scanner from Siemens, Germany, with a 16-channel phased-array surface coil, and the scanning range was from the superior margin of the iliac wing to the inferior margin of the pubic symphysis.

MIBC neoadjuvant evaluation study-MRI

Patients diagnosed with MIBC receive MRI examination before and after neoadjuvant therapy.

Group Type: ACTIVE_COMPARATOR

imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI

Intervention Type: PROCEDURE

FAPI PET/MRI and FDG PET/MRI examination Data acquisition was performed using a GE Healthcare SIGNA PET/MR instrument. Enrolled patients were injected intravenously with 68Ga-FAPI or 18F-FDG tracer and underwent simultaneous PET and MRI scanning approximately 30-60 minutes after intravenous administration of the tracer at a dose of 1.85-3.7 MBq/kg.

MRI examination MRI examination was performed using a Skyra 3.0T MRI scanner from Siemens, Germany, with a 16-channel phased-array surface coil, and the scanning range was from the superior margin of the iliac wing to the inferior margin of the pubic symphysis.

Interventions

imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI

FAPI PET/MRI and FDG PET/MRI examination Data acquisition was performed using a GE Healthcare SIGNA PET/MR instrument. Enrolled patients were injected intravenously with 68Ga-FAPI or 18F-FDG tracer and underwent simultaneous PET and MRI scanning approximately 30-60 minutes after intravenous administration of the tracer at a dose of 1.85-3.7 MBq/kg.

MRI examination MRI examination was performed using a Skyra 3.0T MRI scanner from Siemens, Germany, with a 16-channel phased-array surface coil, and the scanning range was from the superior margin of the iliac wing to the inferior margin of the pubic symphysis.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Patients with suspected muscle-invasive bladder cancer;

2. Completion of FAPI PET/MRI, FDG PET/MRI and MRI;

3. Complete clinical laboratory and pathological data.

1. Patients diagnosed with muscle invasive bladder cancer;

2. Completion of FAPI PET/MRI, FDG PET/MRI, and MRI before neoadjuvant therapy;

3. Complete clinical laboratory and pathological data.

Exclusion Criteria

1. Combined with other malignant tumors;

2. Not receiving surgical treatment;

3. Receiving neoadjuvant therapy before surgery;

4. Previous allergy to contrast components or similar components;

5. Serious organ function abnormalities, such as heart, lung, liver, kidney function serious abnormalities;

6. Incomplete clinicopathological data

1. Combination of other malignant tumors;

2. FAPI PET/MRI, FDG PET/MRI and MRI were not completed after neoadjuvant therapy;

3. Prior hypersensitivity to contrast components or similar components;

4. Serious organ function abnormalities, such as serious abnormalities of heart, lung, liver and kidney function;

5. Incomplete clinicopathological data.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ning Xu

Deputy Director of Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xue-Yi Xue, Master

Role: STUDY_CHAIR

First Affiliated Hospital of Fujian Medical University

Locations

first hospital affiliated of Fujian medical university

Fuzhou, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ning Xu, Doctor

Role: CONTACT

drxun@fjmu.edu.cn

13235907575 ext. 0086

Xiao-Dong Li, Master

Role: CONTACT

lixiaodong@fjmu.edu.cn

15980273075 ext. 0086

Facility Contacts

Xu Ning, M.D.

Role: primary

Other Identifiers

2024-041-02

Identifier Type: -

Identifier Source: org_study_id