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New treatment option for Urinary Bladder Neoplasms
Official title Virtual Histology of the Bladder Wall for Bladder Cancer Staging
ClinicalTrials.gov ID: NCT04369560
What this study is testing
What is Gadobutrol intravesical administration (4mM)?
Gadobutrol intravesical administration (4mM) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for urinary bladder neoplasms.
Also referred to as Image result for other names for Gadobutrol Gadavist.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- 18 to 90 years of age
- Able to understand and willing to sign a written informed consent document
- A papillary tumor identified by cystoscopy that has been scheduled for TURBT OR histologically proven MIBC that is clinically localized and amenable...
- Performance status of ECOG 0 or 1
- Normal renal function as defined as creatinine less than 1.5 x institutional upper limit of normal (ULN) OR creatinine clearance greater than or...
You likely can't join if
- Severe hypersensitivity reaction to gadobutrol or ferumoxytol.
- Severe claustrophobia that will prevent completion of the MRI study.
- Any MRI-non-compatible implanted device, prosthetic or pacemaker.
- Known or suspected metastatic disease.
- Women with active pregnancy, lactation or plans to conceive
- Untreated urinary tract infection
See the full eligibility criteria
- 18 to 90 years of age
- Able to understand and willing to sign a written informed consent document
- 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.
- Performance status of ECOG 0 or 1
- 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 people with...
- Severe hypersensitivity reaction to gadobutrol or ferumoxytol.
- Severe claustrophobia that will prevent completion of the MRI study.
- Any MRI-non-compatible implanted device, prosthetic or pacemaker.
- Known or suspected metastatic disease.
- Women with active pregnancy, lactation or plans to conceive
- Untreated urinary tract infection
- Known urethral stricture disease that would prohibit placement of foley catheter.
- Any other conditions considered as unacceptable risk by the treating physician
The study team makes the final eligibility decision.
Where it's taking place
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.