NCT06421142|RecruitingDMC

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

Application Research of FAPI Positron Emission Tomography(PET)/MRI, 18F-Fluorodeoxyglucose (FDG) PET/MRI, and MRI in the Diagnosis of Muscular Invasive Bladder Cancer and Evaluation of Neoadjuvant Therapy Efficacy

First Affiliated Hospital of Fujian Medical University ClinicalTrials.gov

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1 other identifier

2024-041-02

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredMay 2024

StartedAug 2024

CompletionJun 2029

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for not_applicable

Timeline

36mo left

Started Aug 2024

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.8 years study duration

Study Progress39%

Aug 2024Jun 2029

First Submitted

Initial submission to the registry

May 9, 2024

Completed

11 days until next milestone

First Posted

Study publicly available on registry

May 20, 2024

Completed

2 months until next milestone

Study Start

First participant enrolled

August 2, 2024

Completed

4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected

10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

June 1, 2026

Status Verified

May 1, 2026

Enrollment Period

4 years

First QC Date

May 9, 2024

Last Update Submit

May 28, 2026

Conditions

Urinary Bladder Neoplasms

Keywords

Neoadjuvant ChemotherapyNeoplasm Staging

Outcome Measures

Primary Outcomes (18)

Diagnostic Sensitivity
It is the percentage of patients who will be correctly judged as positive (true positive) if they actually have muscle invasive bladder cancer. The formula is TP/(TP+FN)×100%.TP is true positive and FN is false negative.
Within 1 week after obtaining the surgical pathology report and imaging report results
Diagnostic Specificity
the percentage of patients who are not actually suffering from muscle invasive bladder cancer correctly judged as negative (true negative). The formula is TN/(TN+FP)×100%.TN is true negative, FP is false positive.
Within 1 week after obtaining the surgical pathology report and imaging report results
Positive Expected Value (PPV)
the ratio of true positives among the positive results obtained by a specific test method. The formula is: PPV=TP/(TP+FP)×100%.
Within 1 week after obtaining the surgical pathology report and imaging report results
Negative Expected Value (NPV)
refers to the ratio of true negatives among the negative results obtained by a specific test method. The formula is: NPV=TN/(TN+FN)×100%.
Within 1 week after obtaining the surgical pathology report and imaging report results
Positive Likelihood Ratio (PLR)
the ratio of the probability that a patient who actually has muscle invasive bladder cancer is judged to be positive to the probability that a patient who actually does not have muscle invasive bladder cancer is judged to be positive. The formula was calculated as +LR = sensitivity/(1-specificity) × 100%.
Within 1 week after obtaining the surgical pathology report and imaging report results
Negative Likelihood Ratio (NLR)
the ratio of the probability that a patient who actually has muscle invasive bladder cancer is judged negative to the probability that a patient who actually does not have muscle invasive bladder cancer is judged negative. The formula is: -LR=(1-sensitivity)/specificity×100%.
Within 1 week after obtaining the surgical pathology report and imaging report results
Youden Index
the sum of sensitivity and specificity minus 1. Correct diagnostic index can be used for the comparison of two diagnostic methods, and the ideal correct diagnostic index is 100%. r = (specificity + sensitivity) - 1 = 1 - (false positive rate + false negative rate)
Within 1 week after obtaining the surgical pathology report and imaging report results
Standardized uptake values peak, maximum, and mean (SUVpeak , SUVmax, SUVmean)
changes in SUVmax, SUVmean, and SUVpeak of the tumor lesion before and after treatment obtained from PET/MRI images.
Within 1 week after obtaining the surgical pathology report and imaging report results
Tumor-to-Background Ratio (TBR)
changes in the ratio of the radioactivity of tumor tissue to the radioactivity of background tissue obtained from PET/MRI images before and after treatment.
Within 1 week after obtaining the surgical pathology report and imaging report results
Complete Remission (CR)
In RECIST 1.1 Efficacy assessment criteria for conventional imaging, CR was defined as the disappearance of all target lesions, the absence of new lesions, and the normalization of tumor markers for at least 4 weeks. In PERCIST 1.1 efficacy evaluation criteria for FAPI PET/MRI and FDG PET/MRI, CR refers to the complete disappearance of tracer uptake.
Within 1 month after obtaining the surgical pathology report and imaging report results
Partial Remission (PR)
In RECIST 1.1 Efficacy assessment criteria for conventional imaging, PR was defined as a decrease of ≥30% in the sum of the largest diameters of target lesions for at least 4 weeks. In PERCIST 1.1 efficacy evaluation criteria for FAPI PET/MRI and FDG PET/MRI, PR refers to a decrease of \>30% in the peak SUV.
Within 1 month after obtaining the surgical pathology report and imaging report results
Stable Disease (SD)
In RECIST 1.1 Efficacy assessment criteria for conventional imaging, SD was defined as a decrease in the sum of the largest diameters of the target lesions that did not reach PR or an increase in the size of the largest diameters of target lesions that did not reach PD. In PERCIST 1.1 efficacy evaluation criteria for FAPI PET/MRI and FDG PET/MRI, SD refers to a decrease of \>30% in the peak SUV.
Within 1 month after obtaining the surgical pathology report and imaging report results
Progressive Disease (PR)
In RECIST 1.1 Efficacy assessment criteria for conventional imaging, PD was defined as an increase in the sum of the largest diameters of the target lesions by at least ≥20% or the emergence of new lesions. In PERCIST 1.1 efficacy evaluation criteria for FAPI PET/MRI and FDG PET/MRI, PD refers to an increase of \>30% in the peak SUL or the appearance of new lesions.
Within 1 month after obtaining the surgical pathology report and imaging report results
Complete Metabolic Response (CMR)
For participants receiving FAPI PET/MRI and FDG PET/MRI, according to EORTC efficacy assessment criteria, CMR refers to the complete disappearance of tracer uptake.
Within 1 month after obtaining the surgical pathology report and imaging report results
Partial Metabolic Response (PMR)
For participants receiving FAPI PET/MRI and FDG PET/MRI, according to EORTC efficacy assessment criteria, PMR refers to a reduction in SUV of ≥15%-25% after one cycle of treatment and a reduction in SUV of \>25% after greater than one cycle of treatment.
Within 1 month after obtaining the surgical pathology report and imaging report results
Stable Metabolic Disease (SMD)
For participants receiving FAPI PET/MRI and FDG PET/MRI, according to EORTC efficacy assessment criteria, SMD refers to an increase in SUV of \<25% or a decrease of \<15%, and tumor no significant increase in the extent of uptake (\>20% increase in maximum diameter)
Within 1 month after obtaining the surgical pathology report and imaging report results
Progressive Metabolic Disease (PMD)
For participants receiving FAPI PET/MRI and FDG PET/MRI, according to EORTC efficacy assessment criteria, PMD refers to an increase in SUV value of \>25% and a significant increase in the extent of tumor uptake (increase in the largest diameter of \>20%), or the appearance of new foci.
Within 1 month after obtaining the surgical pathology report and imaging report results
Pathologic Response
According to pathological efficacy assessment criteria, Pathological Complete Remission(pCR) refers to no detectable tumor (pT0) or residual cancer confined to the original site (pTis) after treatment. According to pathological efficacy assessment criteria, A decrease in tumor stage from cT2 (Muscle-Invasive Bladder Cancer - MIBC) to non-muscle-invasive bladder cancer (NMIBC), including stages pT0, pTis, pTa, and pT1, indicates a treatment-sensitive tumor and is considered a good pathologic response. Conversely, if the tumor stage remains the same or increases, it is considered a poor pathologic response.
Within 1 month after obtaining the surgical pathology report and imaging report results

Secondary Outcomes (4)

Overall Survival (OS)
1 years to 3 years after receiving treatment
Radiographic Progression Free Survival (rPFS)
1 years to 3 years after receiving treatment
Overall Remission Rate (Objective Response Rate, ORR)
Within 1 month after obtaining the surgical pathology report and imaging report results
Disease Control Rate (DCR)
Within 1 month after obtaining the surgical pathology report and imaging report results