# Virtual Histology of the Bladder Wall for Bladder Cancer Staging

> **NIH NIH R21** · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · 2020 · $326,485

## Abstract

Bladder cancer (BCa) is one the five most common malignancies worldwide, which is staged by the
penetration of bladder tumor in different layers of bladder wall for optimal treatment. Currently, a costly regimen
of routine cystoscopy, transurethral resection of the tumor (TURBT) and imaging surveillance is recommended
to counter the high BCa recurrence rate of 80%. Although radical cystectomy is the gold standard for staging
accuracy, it is not practical for directing treatment. Since TURBT and available imaging modalities suffer from a
~50% failure rate in detecting muscle invasion, there is an unmet need for safe, radiologic measures to
distinguish indolent from aggressive BCa for surveillance, to select patients for appropriate regimens of bladder
sparing neoadjuvant therapy and to minimize the delay in curative cystectomy of aggressive BCa. Although
dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) after intravenous injection of gadolinium-
based contrast agent (GBCA) was dramatically superior to computed tomography for tumor staging of BCa,
MRI is relatively poorly developed and major barriers still exist in the adaption of MRI for BCa diagnosis and
prognosis. Besides, injected GBCA carries the risk of allergic reaction, health risk and increased healthcare
cost. The scientific premise of this exploratory study is based on our recent report of high-resolution MRI of
rodent and human bladder wall following direct bladder instillation (via urethral catheter) of a novel contrast
mixture (NCM) composed of Gadobutrol (GBCA) and Ferumoxytol in sterile water for positive contrast in
bladder wall via diffusion of GBCA and simultaneous negative contrast in bladder lumen via retention of
Ferumoxytol (molecular size 10 fold of GBCA). Thus, NCM enhanced T1 weighted MRI can leverage the
differential GBCA permeability of cancerous and normal cells in bladder wall to accomplish three-dimensional
(3D) bladder wall imaging for improved tumor detection and non-surgical BCa staging. Following specific aims
are designed to establish the technical and scientific merit of NCM-MRI for BCa staging, before pursuing a
future randomized clinical trial towards the goal of making high resolution 3D MRI, a clinical standard in BCa
diagnosis and treatment. Aim 1 will evaluate the intermodality agreement between histopathologic staging of
TURBT specimens and the pre-operative clinical staging of BCa by abbreviated NCM-MRI in 21 patients with
at least one cystoscopically confirmed papillary bladder tumor. Aim 2 will evaluate the intermodality agreement
between preoperative NCM-MRI for BCa staging with the gold standard of whole-mount pathologic review
of cystectomy specimen in 21 histologically proven muscle invasive BCa patients. The strength of intermodality
agreement between NCM-MRI and the histopathology will be assessed by Kappa (κ) statistics and the relative
differences of two techniques by paired t test. MRI based active surveillance has transformed the...

## Key facts

- **NIH application ID:** 10044470
- **Project number:** 1R21CA252590-01
- **Recipient organization:** UNIVERSITY OF PITTSBURGH AT PITTSBURGH
- **Principal Investigator:** JODI Kathleen MARANCHIE
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $326,485
- **Award type:** 1
- **Project period:** 2020-08-01 → 2024-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10044470

## Citation

> US National Institutes of Health, RePORTER application 10044470, Virtual Histology of the Bladder Wall for Bladder Cancer Staging (1R21CA252590-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10044470. Licensed CC0.

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