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Virtual Histology of the Bladder Wall for Bladder Cancer Staging

ConditionUrinary Bladder Neoplasms
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-90
SponsorJodi Maranchie

About this trial

This is a phase Ib study of the safety and performance of a novel intravesical contrast-enhanced Magnetic Resonance Imaging protocol for determination of bladder cancer stage prior to transurethral resection of bladder tumor (21 subjects) or prior to radical cystectomy for muscle invasive disease (21 subjects). Subjects will undergo a single MRI study: a pre-contrast, single breath hold image followed by sterile placement of a temporary urethral catheter for instillation of a 50mL solution containing Gadobutrol (4 mM) plus ferumoxytol (5 mM) and then a second, post-contrast image. Images will be reviewed by two dedicated abdominal radiologists, who are blinded to the pathologic staging, for determination of tumor presence and depth of bladder wall penetration.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 to 90 years of age

Able to understand and willing to sign a written informed consent document

A papillary tumor identified by cystoscopy that has been scheduled for TURBT OR histologically proven MIBC that is clinically localized and amenable to surgical resection with curative intent.

Performance status of ECOG 0 or 1

Disqualifiers

Severe hypersensitivity reaction to gadobutrol or ferumoxytol.

Severe claustrophobia that will prevent completion of the MRI study.

Any MRI-non-compatible implanted device, prosthetic or pacemaker.

Known or suspected metastatic disease.

Trial design

Design model

Single group

Treatments tested in this trial

  • Magnetic Resonance Imaging

    Diagnostic test

    60-cm wide bore 3T scanner (Siemens AG, Erlangen, Germany) with a 32-channel pelvic phased-array coil placed over the bladder.

  • Gadobutrol intravesical administration (4mM)

    Drug

    A paramagnetic macrocyclic gadolinium-based contrast agent administered intravenously for use in magnetic resonance imaging. Contrast-enhancement is a result of the neutral complex of gadolinium and dihydroxy-hydroxymethylpropyl- tetraazacyclododecane-triacetic acid (butrol).

  • Ferumoxytol intravesical administration (5 mM)

    Drug

    An iron preparation (Fe3O4) approved for intravenous treatment of anemia in the setting of renal failure, comprised of superparamagnetic iron oxide nanoparticles which are coated by a semi-synthetic carbohydrate shell in an isotonic, neutral pH solution.

Treatment groups

42 Participants
are divided into 1 treatment group
Group A: Magnetic Resonance ImagingExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Accuracy of Magnetic Resonance Imaging assessment of depth of bladder wall penetration to predict pathologic stage determined at tumor resection

The assessment of clinical tumor stage assigned by the radiologist will be compared to the stage reported by the clinical pathologist following tumor resection to determine the overall accuracy of MRI for bladder cancer staging.

Time frame
4 weeks

Secondary outcomes

1

Accuracy of Magnetic Resonance Imaging to detect residual/recurrent bladder tumor

Patients are typically scheduled for radical cystectomy after initial TURBT with or without neoadjuvant chemotherapy. MRI findings of bladder tumor will be compared with the areas of tumor identified on whole mount sectioning of the bladder to estimate the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of MRI for bladder cancer. Receiver operating characteristic (ROC) curve analysis will be used to estimate the tumor size threshold value for the diagnosis with MRI.

Time frame
4 weeks
2

Rate of Adverse Events

Characterize the safety profile of MRI imaging following direct bladder instillation of a mixture of Gadobutrol and Ferumoxytrol (50mL in sterile water) via urethral catheter by soliciting and recording adverse events while on study.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jodi Maranchie

Lead sponsor

University of Pittsburgh

Sponsor institution

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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