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.
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.
|Overal Status||Start Date||Phase||Study Type|
|Recruiting||September 2020||Early Phase 1||Interventional|
Primary Outcome 1 - Measure: Accuracy of Magnetic Resonance Imaging assessment of depth of bladder wall penetration to predict pathologic stage determined at tumor resection
Primary Outcome 1 - Time Frame: 4 weeks
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 Cockroft-Gault formula for subjects with creatinine levels greater than or equal
to 1.5 x ULN.
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
Minimum Age: 18 Years
Maximum Age: 90 Years
Healthy Volunteers: No
Name: Jodi K Maranchie, MD
Role: Principal Investigator
Affiliation: Associate Professor