Virtual Histology of the Bladder Wall for Bladder Cancer Staging

NCT ID: NCT04369560

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-23
• Study Completion Date: 2028-12-30

Brief Summary

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.

Detailed Description

Twenty one patients with at least one cystoscopically confirmed papillary bladder tumor, who have been scheduled for Transurethral Resection of Bladder Tumor (TURBT) for surgical extirpation and staging, and twenty-one patients with histologically confirmed, muscle invasive transitional cell carcinoma of the bladder who have been scheduled for definitive radical cystectomy with curative intent will be recruited for a single study Magnetic Resonance Imaging to be performed between 1 and 6 days prior to their scheduled procedure.

Magnetic Resonance Imaging of all the enrolled patients will be performed on a 60-cm, wide-bore, 3T scanner (Siemens AG, Erlangen, Germany) with a 32-channel pelvic phased-array coil placed over the bladder using radial k-space sampling technique for volumetric free breathing acquisition with NCM enhanced StarVIBE57. Un-enhanced fast spoiled gradient-echo images with fat suppression will be obtained prior aseptic instillation of 50cc of a novel contrast mixture (NCM) of Gadobutrol (4 mM) plus Ferumoxytol (5 mM) in sterile water through a temporary urethral catheter. The catheter will then be removed and the patient repositioned in the scanner to obtain post-contrast images. All the image datasets will be linearly registered to the subject to ensure that regions of interest represent the same anatomical location at all time points. Post-contrast T1, pre-contrast T1 and deltaT1 will be measured from the acquired images. Two radiologists blinded to the pathologic findings will evaluate the Magnetic Resonance images to assign a radiologic tumor stage that will be compared with the subsequent pathologic stage determined at time of surgery. Following the MRI study, subjects will proceed with their surgical procedure as scheduled per standard of care.

Conditions

Urinary Bladder Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Magnetic Resonance Imaging

Prior to planned surgical resection, subjects will undergo a single Magnetic Resonance Imaging study: a single breath-hold pre-contrast 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 a second, single breath hold post-contrast image.

Group Type: EXPERIMENTAL

Magnetic Resonance Imaging

Intervention Type: 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)

Intervention Type: 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)

Intervention Type: 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.

Interventions

Magnetic Resonance Imaging

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

Intervention Type: DIAGNOSTIC_TEST

Gadobutrol intravesical administration (4mM)

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).

Intervention Type: DRUG

Ferumoxytol intravesical administration (5 mM)

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.

Intervention Type: DRUG

Other Intervention Names

Image result for other names for Gadobutrol Gadavist; FERAHEME

Eligibility Criteria

Inclusion Criteria

1. 18 to 90 years of age

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

3. 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.

4. Performance status of ECOG 0 or 1

5. Normal renal function as defined as creatinine less than 1.5 x institutional upper limit of normal (ULN) OR creatinine clearance greater than or equal to 50 mL/min/1.73 m2 by Cockcroft-Gault formula for subjects with creatinine levels greater than or equal to 1.5 x ULN.

Exclusion Criteria

1. Severe hypersensitivity reaction to gadobutrol or ferumoxytol.

2. Severe claustrophobia that will prevent completion of the MRI study.

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

4. Known or suspected metastatic disease.

5. Women with active pregnancy, lactation or plans to conceive

6. Untreated urinary tract infection

7. Known urethral stricture disease that would prohibit placement of foley catheter.

8. Any other conditions considered as unacceptable risk by the treating physician

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Jodi Maranchie

OTHER

Sponsor Role: lead

Responsible Party

Jodi Maranchie

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jodi K Maranchie, MD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

UPMC Hillman Cancer Center - Dept of Urology

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Brieanna Marino, MS

Role: CONTACT

rowlesbm@upmc.edu

(412) 647-8258

Facility Contacts

Brieanna HC Marino, MS

Role: primary

rowlesbm@upmc.edu

(412) 647-8258

Other Identifiers

HCC 20-054

Identifier Type: -

Identifier Source: org_study_id