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Virtual Histology of the Bladder Wall for Bladder Cancer Staging

RecruitingEARLY Phase 1Ages 18 Years - 90 YearsAllJodi Maranchie
NCT04369560 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Magnetic Resonance Imaging
  • Gadobutrol intravesical administration (4mM)
  • Ferumoxytol intravesical administration (5 mM)
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Where

1 site
UPMC Hillman Cancer Center - Dept of Urology
Pittsburgh, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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