MRI and Bladder Cancer Chemotherapy
Withdrawn before enrolling
Conditions studied: Invasive Bladder Cancer
In brief
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.
Key facts
- Study ID
- NCT01922232
- Run by
- NYU Langone Health
- People needed
- 0
- Starts
- 2013-08-01
- Expected to finish
- 2014-07-01
- Last updated by the study team
- 2014-10-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- NYU Langone Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
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