Urinary Bladder NeoplasmsEarly Phase 1NCT04369560
Virtual Histology of the Bladder Wall for Bladder Cancer Staging
A Early Phase 1 study testing Magnetic Resonance Imaging, Gadobutrol intravesical administration (4mM) and Ferumoxytol intravesical administration (5 mM) in people with Urinary Bladder Neoplasms, run by Jodi Maranchie at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Urinary Bladder Neoplasms
- What is being tested?
- Magnetic Resonance Imaging, Gadobutrol intravesical administration (4mM) and Ferumoxytol intravesical administration (5 mM)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2025to 30 Dec 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 subjects with creatinine levels greater than or equal to 1.5 x ULN.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UPMC Hillman Cancer Center - Dept of Urology
Pittsburgh, Pennsylvania, 15232
Brieanna HC Marino, MS, (412) 647-8258, rowlesbm@upmc.edu
About this study
Official title: Virtual Histology of the Bladder Wall for Bladder Cancer Staging; A Novel Intravesical Contrast-Enhanced MRI for Bladder Cancer Staging
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.
Read the detailed description
Twenty one patients with at least one cystoscopically confirmed papillary bladder tumor, who have been scheduled for Transurethral Resection of Bladder Tumor (TURBT) for surgical extirpation and staging, and twenty-one patients with histologically confirmed, muscle invasive transitional cell carcinoma of the bladder who have been scheduled for definitive radical cystectomy with curative intent will be recruited for a single study Magnetic Resonance Imaging to be performed between 1 and 6 days prior to their scheduled procedure.
Magnetic Resonance Imaging of all the enrolled patients will be performed on a 60-cm, wide-bore, 3T scanner (Siemens AG, Erlangen, Germany) with a 32-channel pelvic phased-array coil placed over the bladder using radial k-space sampling technique for volumetric free breathing acquisition with NCM enhanced StarVIBE57. Un-enhanced fast spoiled gradient-echo images with fat suppression will be obtained prior aseptic instillation of 50cc of a novel contrast mixture (NCM) of Gadobutrol (4 mM) plus Ferumoxytol (5 mM) in sterile water through a temporary urethral catheter. The catheter will then be removed and the patient repositioned in the scanner to obtain post-contrast images. All the image datasets will be linearly registered to the subject to ensure that regions of interest represent the same anatomical location at all time points. Post-contrast T1, pre-contrast T1 and deltaT1 will be measured from the acquired images. Two radiologists blinded to the pathologic findings will evaluate the Magnetic Resonance images to assign a radiologic tumor stage that will be compared with the subsequent pathologic stage determined at time of surgery. Following the MRI study, subjects will proceed with their surgical procedure as scheduled per standard of care.
- Conditions
- Urinary Bladder Neoplasms
- Being tested
- Magnetic Resonance Imaging, Gadobutrol intravesical administration (4mM), Ferumoxytol intravesical administration (5 mM)
- Keywords
- TURBT, Complete Cystectomy
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingDiagnostic test
60-cm wide bore 3T scanner (Siemens AG, Erlangen, Germany) with a 32-channel pelvic phased-array coil placed over the bladder.
Gadobutrol intravesical administration (4mM)Drug
Also called Image result for other names for Gadobutrol Gadavist
A paramagnetic macrocyclic gadolinium-based contrast agent administered intravenously for use in magnetic resonance imaging. Contrast-enhancement is a result of the neutral complex of gadolinium and dihydroxy-hydroxymethylpropyl- tetraazacyclododecane-triacetic acid (butrol).
Ferumoxytol intravesical administration (5 mM)Drug
Also called FERAHEME
An iron preparation (Fe3O4) approved for intravenous treatment of anemia in the setting of renal failure, comprised of superparamagnetic iron oxide nanoparticles which are coated by a semi-synthetic carbohydrate shell in an isotonic, neutral pH solution.
| Study group | Role | What they receive |
|---|---|---|
| Magnetic Resonance Imaging | Experimental | 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. Receives: Diagnostic Test: Magnetic Resonance Imaging; Drug: Gadobutrol intravesical administration (4mM); Drug: Ferumoxytol intravesical administration (5 mM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Magnetic Resonance Imaging assessment of depth of bladder wall penetration to predict pathologic stage determined at tumor resection
The assessment of clinical tumor stage assigned by the radiologist will be compared to the stage reported by the clinical pathologist following tumor resection to determine the overall accuracy of MRI for bladder cancer staging.
Measured: 4 weeks
Secondary outcomes (2)
Accuracy of Magnetic Resonance Imaging to detect residual/recurrent bladder tumor
Patients are typically scheduled for radical cystectomy after initial TURBT with or without neoadjuvant chemotherapy. MRI findings of bladder tumor will be compared with the areas of tumor identified on whole mount sectioning of the bladder to estimate the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of MRI for bladder cancer. Receiver operating characteristic (ROC) curve analysis will be used to estimate the tumor size threshold value for the diagnosis with MRI.
Measured: 4 weeks
Rate of Adverse Events
Characterize the safety profile of MRI imaging following direct bladder instillation of a mixture of Gadobutrol and Ferumoxytrol (50mL in sterile water) via urethral catheter by soliciting and recording adverse events while on study.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start23 May 2025
- Primary completion30 Jan 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Diagnostic Test - Magnetic Resonance Imaging
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jodi Maranchie
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Jodi Maranchie, University of Pittsburgh
- Investigators
- Jodi K Maranchie, MD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04369560
- Sponsor's protocol ID
- HCC 20-054
- Status last verified
- Dec 2025
- First submitted
- 27 Apr 2020
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 1. What data will be shared? The investigators will share the accuracy of the MRI staging versus the traditional pathological staging. 2. Who will have access to the data? The investigators and future researchers who provide the proper MTA, IRB, etc. will have access to the de-identified data. 3. Where will the data to be shared be located? De-identified data will be kept on the UPMC cloud. 4. When will the data be shared? The data will be available to share after final analysis and publication of results. 5. How will researchers locate and access the data? A link to the Cloud folder will be provided.
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Histology of the Bladder Wall for Bladder Cancer Staging; A Novel Intravesical Contrast-Enhanced MRI for Bladder Cancer Staging
- ClinicalTrials.gov ID
- NCT04369560
- Acronym / sponsor ID
- HCC 20-054
- Conditions
- Urinary Bladder Neoplasms
- Keywords
- TURBT, Complete Cystectomy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Jodi MaranchieUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 23 May 2025 (actual)
- Primary completion
- 30 Jan 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 30 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Twenty one patients with at least one cystoscopically confirmed papillary bladder tumor, who have been scheduled for Transurethral Resection of Bladder Tumor (TURBT) for surgical extirpation and staging, and twenty-one patients with histologically confirmed, muscle invasive transitional cell carcinoma of the bladder who have been scheduled for definitive radical cystectomy with curative intent will be recruited for a single study Magnetic Resonance Imaging to be performed between 1 and 6 days prior to their scheduled procedure.
Magnetic Resonance Imaging of all the enrolled patients will be performed on a 60-cm, wide-bore, 3T scanner (Siemens AG, Erlangen, Germany) with a 32-channel pelvic phased-array coil placed over the bladder using radial k-space sampling technique for volumetric free breathing acquisition with NCM enhanced StarVIBE57. Un-enhanced fast spoiled gradient-echo images with fat suppression will be obtained prior aseptic instillation of 50cc of a novel contrast mixture (NCM) of Gadobutrol (4 mM) plus Ferumoxytol (5 mM) in sterile water through a temporary urethral catheter. The catheter will then be removed and the patient repositioned in the scanner to obtain post-contrast images. All the image datasets will be linearly registered to the subject to ensure that regions of interest represent the same anatomical location at all time points. Post-contrast T1, pre-contrast T1 and deltaT1 will be measured from the acquired images. Two radiologists blinded to the pathologic findings will evaluate the Magnetic Resonance images to assign a radiologic tumor stage that will be compared with the subsequent pathologic stage determined at time of surgery. Following the MRI study, subjects will proceed with their surgical procedure as scheduled per standard of care.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Diagnostic Test - Magnetic Resonance Imaging
| Arm | Type | Receives |
|---|---|---|
| Magnetic Resonance Imaging | Experimental | Diagnostic Test: Magnetic Resonance Imaging, Drug: Gadobutrol intravesical administration (4mM), Drug: Ferumoxytol intravesical administration (5 mM)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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 subjects with creatinine levels greater than or equal to 1.5 x ULN.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Imaging60-cm wide bore 3T scanner (Siemens AG, Erlangen, Germany) with a 32-channel pelvic phased-array coil placed over the bladder. | Diagnostic test | Magnetic Resonance Imaging |
| Gadobutrol intravesical administration (4mM)Also: Image result for other names for Gadobutrol GadavistA paramagnetic macrocyclic gadolinium-based contrast agent administered intravenously for use in magnetic resonance imaging. Contrast-enhancement is a result of the neutral complex of gadolinium and dihydroxy-hydroxymethylpropyl- tetraazacyclododecane-triacetic acid (butrol). | Drug | Magnetic Resonance Imaging |
| Ferumoxytol intravesical administration (5 mM)Also: FERAHEMEAn iron preparation (Fe3O4) approved for intravenous treatment of anemia in the setting of renal failure, comprised of superparamagnetic iron oxide nanoparticles which are coated by a semi-synthetic carbohydrate shell in an isotonic, neutral pH solution. | Drug | Magnetic Resonance Imaging |
Primary outcome
Accuracy of Magnetic Resonance Imaging assessment of depth of bladder wall penetration to predict pathologic stage determined at tumor resection
Time frame: 4 weeks
The assessment of clinical tumor stage assigned by the radiologist will be compared to the stage reported by the clinical pathologist following tumor resection to determine the overall accuracy of MRI for bladder cancer staging.
2 secondary outcomes
Accuracy of Magnetic Resonance Imaging to detect residual/recurrent bladder tumor
Time frame: 4 weeks
Rate of Adverse Events
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No. 1. What data will be shared? The investigators will share the accuracy of the MRI staging versus the traditional pathological staging. 2. Who will have access to the data? The investigators and future researchers who provide the proper MTA, IRB, etc. will have access to the de-identified data. 3. Where will the data to be shared be located? De-identified data will be kept on the UPMC cloud. 4. When will the data be shared? The data will be available to share after final analysis and publication of results. 5. How will researchers locate and access the data? A link to the Cloud folder will be provided.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jodi K Maranchie, MD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Magnetic Resonance Imaging, Gadobutrol intravesical administration (4mM) and Ferumoxytol intravesical administration (5 mM) in people with Urinary Bladder Neoplasms, run by Jodi Maranchie at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brieanna Marino, MS ((412) 647-8258, rowlesbm@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Magnetic Resonance Imaging assessment of depth of bladder wall penetration to predict pathologic stage determined at tumor resection (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.