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Trial Title:
FAPI and FDG PET/MRI in Diagnosis and Therapy Prediction of Bladder Cancer
NCT ID:
NCT06421142
Condition:
Urinary Bladder Neoplasms
Conditions: Official terms:
Urinary Bladder Neoplasms
Conditions: Keywords:
Neoadjuvant Chemotherapy
Neoplasm Staging
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
In the MIBC diagnostic study and neoadjuvant efficacy prediction study, each patient
underwent FAPIPET/MRI, FDGPET/MRI and MRI examinations, and were grouped and analyzed
according to different examination methods.
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI
Description:
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.
Arm group label:
MIBC diagnostic study-FAPI PET/MRI
Arm group label:
MIBC diagnostic study-FDG PET/MRI
Arm group label:
MIBC diagnostic study-MRI
Arm group label:
MIBC neoadjuvant evaluation study-FAPI PET/MRI
Arm group label:
MIBC neoadjuvant evaluation study-FDG PET/MRI
Arm group label:
MIBC neoadjuvant evaluation study-MRI
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Inclusion criteria for MIBC diagnostic studies
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.
- Inclusion criteria for MIBC neoadjuvant therapy efficacy evaluation study
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:
- Exclusion criteria for MIBC diagnostic study
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
- Exclusion criteria of MIBC neoadjuvant therapy efficacy evaluation study
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
first hospital affiliated of Fujian medical university
Address:
City:
Fuzhou
Zip:
350005
Country:
China
Status:
Recruiting
Contact:
Last name:
Xu Ning, M.D.
Start date:
July 1, 2024
Completion date:
June 1, 2025
Lead sponsor:
Agency:
First Affiliated Hospital of Fujian Medical University
Agency class:
Other
Source:
First Affiliated Hospital of Fujian Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06421142
