Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT04806334
Eligibility Criteria:
Inclusion Criteria:
1. Patients must be \> 18 years of age.
2. Patient must have a sessile mass noted within the bladder on cystoscopy or imaging worrisome for bladder cancer, specifically MIBC.
3. Patient must agree to undergo staging which will include mp-4D MRI HR-DWI of the pelvis in addition to standard axial imaging of the abdomen.
4. Patient must be agreeable to undergo planned TURBT as part of the normal treatment course.
5. Patients must not have known or suspected primary urothelial carcinoma of the ureter, urethra, or renal pelvis.
6. Patients must not have known distant metastatic disease (e.g. pulmonary or hepatic metastases). Subjects with malignant lymphadenopathy in the abdomen or pelvis considered appropriate for radical cystectomy and lymphadenectomy with the goal of complete resection of all malignant disease are allowed.
7. Patients must not have had prior definitive treatment for bladder cancer.
8. Patients must not have clinically significant active infection or uncontrolled medical condition that would preclude participation in study.
9. Patients must not have any active malignancy other than urothelial carcinoma of the bladder that, in the opinion of the treating investigator, which could interfere with protocol treatment.
10. Patient must have adequate renal function: Serum creatinine \< 2 mg/dL OR calculated CrCl \> 30ml/min.
11. Patients must not have allergy or contraindication for MRI contrast/contrast dye.
12. Patients must not be under treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \[anti-TNF\] agents) within 2 weeks prior to TURBT.
13. Patient must not be adverse to undergo radical cystectomy as part of the normal treatment course if found to have MIBC.
14. Patients must have the ability to understand and willingness to sign a written informed consent.
Exclusion Criteria:
1. Persons with allergy to animal dander or animal-instigated asthma.
2. Patient must not have undergone a bladder biopsy or limited (incomplete) TURBT within 3 weeks (21 days) of the MRI.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04806334
Study Brief:
Protocol Section:
NCT04806334