Virtual Histology of the Bladder Wall for Bladder Cancer Staging
Recruiting
Early Phase 1Interventional Study
Urinary Bladder Neoplasms
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 90
Sex
Any
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Diagnostic
Participants needed
42 (estimated)
Sponsor
Jodi Maranchie · Other
Who this trial is looking for
This trial is looking for adults with bladder cancer to test a new MRI technique that helps determine the stage of the cancer. Participants will receive a special contrast solution before having an MRI scan.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 90 years old.
I can understand and sign a consent form.
I have a papillary tumor scheduled for surgery.
I have a confirmed muscle invasive bladder cancer that can be surgically removed.
I have a good performance status (ECOG 0 or 1).
I have normal kidney function.
You may not be able to join if
I have a severe allergy to gadobutrol or ferumoxytol.
I have severe claustrophobia that prevents me from having an MRI.
I have an MRI-incompatible device or pacemaker.
I have known or suspected metastatic cancer.
I am currently pregnant, breastfeeding, or planning to become pregnant.
I have an untreated urinary tract infection.
I have a urethral stricture that prevents catheter placement.
I have any other condition deemed an unacceptable risk by my doctor.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 foll…
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.
Trial Locations
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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 wi…
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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