Active — Not RecruitingNot Applicable

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

China80 participantsStarted 2025-11-01

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients with suspected muscle-invasive bladder cancer;
✓. Completion of FAPI PET/MRI, FDG PET/MRI and MRI;
✓. Complete clinical laboratory and pathological data.
✓. Patients diagnosed with muscle invasive bladder cancer;
✓. Completion of FAPI PET/MRI, FDG PET/MRI, and MRI before neoadjuvant therapy;
✓. Complete clinical laboratory and pathological data.

Exclusion criteria

✕. Combined with other malignant tumors;
✕. Not receiving surgical treatment;
✕. Receiving neoadjuvant therapy before surgery;
✕. Previous allergy to contrast components or similar components;
✕. Serious organ function abnormalities, such as heart, lung, liver, kidney function serious abnormalities;
✕. Incomplete clinicopathological data
✕. Combination of other malignant tumors;
✕. FAPI PET/MRI, FDG PET/MRI and MRI were not completed after neoadjuvant therapy;

What they're measuring

Diagnostic Sensitivity

Timeframe: Within 1 week after obtaining the surgical pathology report and imaging report results

Diagnostic Specificity

Timeframe: Within 1 week after obtaining the surgical pathology report and imaging report results

Positive Expected Value (PPV)

Timeframe: Within 1 week after obtaining the surgical pathology report and imaging report results

Negative Expected Value (NPV)

Timeframe: Within 1 week after obtaining the surgical pathology report and imaging report results

Positive Likelihood Ratio (PLR)

Timeframe: Within 1 week after obtaining the surgical pathology report and imaging report results

Negative Likelihood Ratio (NLR)

Timeframe: Within 1 week after obtaining the surgical pathology report and imaging report results

Youden Index

Timeframe: Within 1 week after obtaining the surgical pathology report and imaging report results

Trial details

NCT IDNCT06421142

SponsorFirst Affiliated Hospital of Fujian Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10-01

View on ClinicalTrials.gov More Urinary Bladder Neoplasms trials

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients with suspected muscle-invasive bladder cancer;
✓. Completion of FAPI PET/MRI, FDG PET/MRI and MRI;
✓. Complete clinical laboratory and pathological data.
✓. Patients diagnosed with muscle invasive bladder cancer;
✓. Completion of FAPI PET/MRI, FDG PET/MRI, and MRI before neoadjuvant therapy;
✓. Complete clinical laboratory and pathological data.

Exclusion criteria

✕. Combined with other malignant tumors;
✕. Not receiving surgical treatment;
✕. Receiving neoadjuvant therapy before surgery;
✕. Previous allergy to contrast components or similar components;
✕. Serious organ function abnormalities, such as heart, lung, liver, kidney function serious abnormalities;
✕. Incomplete clinicopathological data
✕. Combination of other malignant tumors;
✕. FAPI PET/MRI, FDG PET/MRI and MRI were not completed after neoadjuvant therapy;

What they're measuring

Diagnostic Sensitivity

Timeframe: Within 1 week after obtaining the surgical pathology report and imaging report results

Diagnostic Specificity

Timeframe: Within 1 week after obtaining the surgical pathology report and imaging report results

Positive Expected Value (PPV)

Timeframe: Within 1 week after obtaining the surgical pathology report and imaging report results

Negative Expected Value (NPV)

Timeframe: Within 1 week after obtaining the surgical pathology report and imaging report results

Positive Likelihood Ratio (PLR)

Timeframe: Within 1 week after obtaining the surgical pathology report and imaging report results

Negative Likelihood Ratio (NLR)

Timeframe: Within 1 week after obtaining the surgical pathology report and imaging report results

Youden Index

Timeframe: Within 1 week after obtaining the surgical pathology report and imaging report results