Enhanced MRI for Bladder Cancer Staging
Recruiting in Palo Alto (17 mi)
Overseen byJodi K Maranchie, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: Jodi Maranchie
Disqualifiers: Metastatic disease, Pregnancy, UTI, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Ferumoxytol, Feraheme, Gadobutrol, Gadavist, Gadobutrol Injection for bladder cancer staging?
Research shows that using gadolinium-based contrast agents in MRI can improve the accuracy of staging bladder cancer, with a study reporting an 83% accuracy rate in identifying tumor stages. Additionally, ferumoxtran-10, a similar agent to ferumoxytol, has been evaluated for its effectiveness in imaging lymph nodes in bladder cancer patients.
12345Is gadobutrol safe for use in humans?
Gadobutrol, a contrast agent used in MRI scans, has been shown to be generally safe and well-tolerated in a wide range of patients, including children and adults with various health conditions. It has a low risk of causing nephrogenic systemic fibrosis, a rare condition associated with some contrast agents, and has been used safely in over 50 million doses.
678910How does enhanced MRI differ from other treatments for bladder cancer staging?
Enhanced MRI for bladder cancer staging is unique because it uses contrast agents like gadolinium to improve the visibility of tumors and their spread, offering better accuracy in identifying the extent of cancer compared to traditional imaging methods. This approach allows for more precise staging, especially for tumors that are difficult to detect with other techniques.
234511Eligibility Criteria
This trial is for adults aged 18-90 with bladder cancer, either scheduled for tumor removal or with muscle-invasive disease suitable for surgery. Participants must be able to consent, have a performance status of ECOG 0 or 1 (fully active or restricted in physically strenuous activity), and normal kidney function. Pregnant women, those with severe allergies to contrast agents used in MRI, extreme claustrophobia, incompatible implants, metastatic disease, urinary infections or urethral strictures cannot join.Inclusion Criteria
I am fully active or can carry out light work.
Able to understand and willing to sign a written informed consent document
I have a bladder tumor scheduled for removal or a muscle-invasive bladder cancer suitable for surgery.
+2 more
Exclusion Criteria
You have had a serious allergic reaction to gadobutrol or ferumoxytol.
I have a urinary tract infection that hasn't been treated.
I am not pregnant, breastfeeding, or planning to become pregnant.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Imaging
Participants undergo a single MRI study with pre-contrast and post-contrast imaging to assess bladder cancer stage
1 day
1 visit (in-person)
Surgical Procedure
Participants proceed with their scheduled surgical procedure (TURBT or radical cystectomy) as per standard of care
1 day
Follow-up
Participants are monitored for safety and effectiveness after the imaging and surgical procedures
4 weeks
Long-term Safety Monitoring
Characterize the safety profile of MRI imaging by soliciting and recording adverse events
2 years
Participant Groups
The study tests a new MRI protocol using Gadobutrol and Ferumoxytol as contrast agents to determine the stage of bladder cancer before surgery. Patients will receive one pre-contrast image followed by an instillation of the contrast solution through a catheter and then a post-contrast image. Two radiologists blind to pathology results will assess tumor presence and invasion depth.
1Treatment groups
Experimental Treatment
Group I: Magnetic Resonance ImagingExperimental Treatment3 Interventions
Prior to planned surgical resection, subjects will undergo a single Magnetic Resonance Imaging study: a single breath-hold pre-contrast 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 a second, single breath hold post-contrast image.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UPMC Department of UrologyPittsburgh, PA
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Who Is Running the Clinical Trial?
Jodi MaranchieLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Dynamic contrast-enhanced magnetic resonance imaging evaluation of VX2 carcinoma in a rabbit model: comparison of 1.0-M gadobutrol and 0.5-M gadopentetate dimeglumine. [2016]To compare the enhancement characteristics and diagnostic performance of 1.0-M gadobutrol with those of 0.5-M gadopentetate dimeglumine in rabbit VX2 tumor models.
Urinary bladder cancer: preoperative nodal staging with ferumoxtran-10-enhanced MR imaging. [2016]To prospectively evaluate ferumoxtran-10-enhanced magnetic resonance (MR) imaging for nodal staging in patients with urinary bladder cancer.
Gadolinium-enhanced magnetic resonance imaging in the staging of urinary bladder neoplasms. [2018]Magnetic resonance imaging (MRI) proved to be an important diagnostic tool in the correct staging of bladder neoplasms. The advantage of multiplane imaging and high soft-tissue contrast may be extended by the use of MRI contrast media such as the gadoliniumdiethylene-triaminepentaacetic acid complex. In 60 patients with suspected or proved bladder tumors, the results of preoperative gadolinium-enhanced MRI were correlated with the histopathologic findings. The staging accuracy of infiltrating tumors was 83% and sensitivity and specificity 86% and 83%, respectively. Three tumors could only be localized after administration of gadolinium. All active tumors demonstrated significant contrast enhancement after intravenously injected gadolinium. Small papillary tumors or carcinoma in situ remain problematic to preoperative staging procedures. The advantages of gadolinium-enhanced MRI will best be employed in the exact pretherapeutic staging of infiltrative bladder neoplasms or in restaging procedures after chemotherapy and radiotherapy.
Preoperative staging of invasive bladder cancer with dynamic gadolinium-enhanced magnetic resonance imaging: results from a prospective study. [2015]To evaluate the accuracy of dynamic gadolinium-enhanced magnetic resonance imaging (DGE-MRI) to detect extravesical bladder cancer (BC) and lymph node-positive disease in patients with invasive BC.
Bladder cancer: evaluation of staging accuracy using dynamic MRI. [2022]To assess the accuracy of magnetic resonance imaging (MRI) in staging bladder cancer and to assess whether dynamic gadolinium-enhanced sequences have any added benefit in staging.
Gadobutrol: a review of its use for contrast-enhanced magnetic resonance imaging in adults and children. [2021]Since the introduction of the first gadolinium-based contrast agent (GBCA) approximately 25 years ago, magnetic resonance imaging (MRI) using GBCAs has revolutionized diagnostic and follow-up imaging of pathological lesions, with clinical applications expanded to encompass almost all fields of medicine. Intravenous gadobutrol (Gadovist™ [EU]; Gadavist(®) [USA]) is a second-generation extracellular non-ionic macrocyclic GBCA that is used in patients undergoing diagnostic contrast-enhanced MRI for visualization of pathological lesions in the CNS and all other body regions or for contrast-enhanced magnetic resonance angiography (MRA) to evaluate perfusion and flow-related abnormalities. Its unique physicochemical profile, along with the high thermostability of macrocyclic GBCAs, means gadobutrol is formulated at twice the gadolinium ion concentration of other currently licensed GBCAs. This reduces the injection volume and provides a narrower bolus, thereby improving image enhancement. Based on extensive clinical experience in a broad range of patients, including paediatric and adult patients (younger and elderly adults), and those with moderate to severe hepatic or renal impairment or cardiovascular disorders, gadobutrol is an effective and generally well tolerated extracellular GBCA for patients undergoing diagnostic contrast-enhanced MRI and contrast-enhanced MRA. As with all macrocyclic GBCAs, the potential for gadobutrol to cause nephrogenic systemic fibrosis appears to be lower than with linear GBCAs.
Are there differences between macrocyclic gadolinium contrast agents for brain tumor imaging? Results of a multicenter intraindividual crossover comparison of gadobutrol with gadoteridol (the TRUTH study). [2021]Gadobutrol (Gadavist) and gadoteridol (ProHance) have similar macrocyclic molecular structures, but gadobutrol is formulated at a 2-fold higher (1 mol/L versus 0.5 mol/L) concentration. We sought to determine whether this difference impacts morphologic contrast-enhanced MR imaging.
Toxicological safety evaluation of gadobutrol. [2019]Gadobutrol (Gadovist/Gadavist, Bayer Pharma AG, Berlin, Germany) is a nonionic, macrocyclic, gadolinium-based contrast agent for magnetic resonance imaging of the central nervous system as well as liver and kidneys and for contrast enhancement in magnetic resonance angiography. For risk assessment of the single diagnostic use in humans, the toxicity of this compound was evaluated with a series of preclinical studies.
Safety of gadobutrol, a new generation of contrast agents: experience from clinical trials and postmarketing surveillance. [2014]To assess the clinical safety and tolerability of the macrocyclic contrast agent gadobutrol (Gadovist/Gadavist) overall and in specific patient populations based on clinical trials and postmarketing experience.
Gadobutrol: A Review in Contrast-Enhanced MRI and MRA. [2022]Intravenous gadobutrol [Gadovist™ (EU); Gadavist® (USA)] is a second-generation, extracellular non-ionic macrocyclic gadolinium-based contrast agent (GBCA) that is approved for use in paediatric (including term neonates) and adult patients undergoing diagnostic contrast-enhanced (CE) MRI for visualization of pathological lesions in all body regions or for CE MRA to evaluate perfusion and flow-related abnormalities. Its unique physicochemical profile, including its high thermostability and proton relaxation times, means that gadobutrol is formulated at twice the gadolinium ion concentration of other GBCAs, resulting in a narrower bolus and consequently, improved dynamic image enhancement. Based on >  20 years of experience in the clinical trial and real-world settings (>  50 million doses) and its low risk for developing nephrogenic systemic fibrosis (NSF), gadobutrol represents an effective and safe diagnostic GBCA for use in CE MRI and MRA to visualize pathological lesions and vascular perfusion and flow-related abnormalities in all body regions in a broad spectrum of patients, including term neonates and other paediatric patients, young and elderly adult patients, and those with moderate or severe renal or hepatic impairment or cardiovascular (CV) disease.
Bladder tumor staging: comparison of conventional and gadolinium-enhanced dynamic MR imaging and CT. [2016]With computed tomography (CT) and unenhanced magnetic resonance (MR) imaging, stage pT3b extravesical extension and beyond can be diagnosed, but tumors confined to the bladder wall (stages pT1-pT3a) are poorly delineated. To determine whether visualization of such tumors could be improved with gadolinium-enhanced MR imaging, dynamic breath-hold T1-weighted MR images were obtained after intravenous infusion of 0.1 mmol/kg gadopentetate dimeglumine in 79 patients (86 tumors). Conventional MR images, CT scans, and histologic correlation were available in all cases. With dynamic gadolinium-enhanced MR imaging, the mucosa could be distinguished from the muscular layers of the bladder wall. Staging accuracy with this technique was 85% (73 of 86), which was significantly better than with CT (55%; 47 of 86) (P