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New MRI dye could help doctors see bladder cancer depth without surgery
NCT ID NCT04369560
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase study tests a new MRI technique that uses two contrast agents (gadobutrol and ferumoxytol) placed directly into the bladder to improve staging of bladder cancer. Researchers will compare MRI images to actual tumor samples from surgery to see if the scan can accurately show how deep the cancer has grown. The study involves 42 adults with bladder tumors who are scheduled for either tumor removal or bladder removal surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Gadobutrol and ferumoxytol (contrast agents)
- What this could lead to
- If successful, this MRI method could help doctors more accurately determine bladder cancer stage without invasive biopsies.
- What could go wrong
- This is a very early phase 1 study with only 42 people. The new MRI technique may not be more accurate than current methods, and there are risks from the contrast agents and catheter placement.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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UPMC Hillman Cancer Center - Dept of Urology
RECRUITINGPittsburgh, Pennsylvania, 15232, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Lab-Grown tumor organoids could pick the right bladder chemo
- A pill instead of surgery? trial tests vepugratinib against Low-Grade bladder cancer
- Can tumor genes decide who keeps their bladder?
- Lab-Grown tumor models could match patients to the right cancer drug
- Can heated saline during bladder surgery stop tumors from coming back?