RECRUITING

Virtual Histology of the Bladder Wall for Bladder Cancer Staging

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Virtual Histology of the Bladder Wall for Bladder Cancer Staging; A Novel Intravesical Contrast-Enhanced MRI for Bladder Cancer Staging

Quick Facts

Study Start:2021-01-06
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04369560

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 18 to 90 years of age
  2. 2. Able to understand and willing to sign a written informed consent document
  3. 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. 4. Performance status of ECOG 0 or 1
  5. 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.
  1. 1. Severe hypersensitivity reaction to gadobutrol or ferumoxytol.
  2. 2. Severe claustrophobia that will prevent completion of the MRI study.
  3. 3. Any MRI-non-compatible implanted device, prosthetic or pacemaker.
  4. 4. Known or suspected metastatic disease.
  5. 5. Women with active pregnancy, lactation or plans to conceive
  6. 6. Untreated urinary tract infection
  7. 7. Known urethral stricture disease that would prohibit placement of foley catheter.
  8. 8. Any other conditions considered as unacceptable risk by the treating physician

Contacts and Locations

Study Contact

Dawn McBride, RN
CONTACT
412-623-2764
mcbridedl@upmc.edu

Principal Investigator

Jodi K Maranchie, MD
PRINCIPAL_INVESTIGATOR
Associate Professor

Study Locations (Sites)

UPMC Department of Urology
Pittsburgh, Pennsylvania, 15232
United States

Collaborators and Investigators

Sponsor: Jodi Maranchie

  • Jodi K Maranchie, MD, PRINCIPAL_INVESTIGATOR, Associate Professor

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-06
Study Completion Date2024-12

Study Record Updates

Study Start Date2021-01-06
Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

  • TURBT
  • Complete Cystectomy

Additional Relevant MeSH Terms

  • Urinary Bladder Neoplasms