MRI and Bladder Cancer Chemotherapy

NCT01922232 | Withdrawn DMC

• 1 other identifier: S13-00240
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective study of pretreatment DW-MRI to identify potential imaging biomarkers predictive of response to neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer. Target enrollment of this study is 40 patients. Patients will first undergo baseline DW-MRI of the Abdomen and Pelvis prior to beginning standard treatment with neoadjuvant cisplatin-based chemotherapy after which DW-MRI will be repeated to assess for response or progression. Patients who remain eligible for surgery will proceed to standard radical cystectomy with pelvic lymph node dissection. DW-MRI metrics including apparent diffusion coefficient (ADC) values will be correlated to pathologic response rate in the radical cystectomy specimen to identify imaging markers predictive of response.

Conditions

Invasive Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Complete pathologic response

  Under one year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with histologically confirmed muscle invasive urothelial carcinoma of the bladder with clinical stage T2-T4a N0/X M0 disease who are candidates for cisplatin-based neoadjuvant chemotherapy and subsequent radical cystectomy

You may qualify if:

• Histologically confirmed muscle invasive urothelial carcinoma of the bladder
• Clinical stage T2-T4a N0/X M0 disease
• Age ≥ 18 years of age
• Medically appropriate candidate for radical cystectomy, as per NYU Attending Urologic Oncologist
• Medically appropriate candidate for cisplatin-based neoadjuvant chemotherapy as per NYU Attending Medical Oncologist
• If female of childbearing potential, pregnancy test is negative

You may not qualify if:

• Prior systemic chemotherapy (prior intravesical therapy is allowed)
• Prior radiation therapy to the bladder
• Medical contraindication to cisplatin-based neoadjuvant chemotherapy as determined by NYU Attending Medical Oncologist
• Concomitant use of any other investigational drugs
• Inability to tolerate MRI including conditions such as claustrophobia or inability to lay flat for \> 45 minutes.
• Presence of pacemaker/ICD or perfusion pumps
• Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial heart, valves with steel parts, metal fragments, shrapnel, bullets, tattoos near the eye, or steel implants.
• Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Study Officials

• Andrew B Rosenkrantz, MD

  NYU Langone Medical Center

  PRINCIPAL INVESTIGATOR

• Arjun Balar, MD

  NYU Langone Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2013
• First Posted: August 14, 2013
• Study Start: August 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: October 2, 2014

Record last verified: 2014-10

Locations

US (1)