Retrospective Review of FDG PET MRI Management of Patients With Muscle Invasive Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

Retrospective Review of FDG PET MRI Management of Patients With Muscle Invasive Bladder Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03327883
• Other study ID #: 999918009
• Secondary ID: 18-C-N009
• Status: Completed
• Start date: October 26, 2017
• Est. completion date: October 16, 2018

Study information

• Verified date: July 2021
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Background: Bladder cancer is a common cancer in the U.S. Survival rates for metastatic bladder cancer have not gotten better for 15 years. Diagnosing and assessing the disease is important for treating it. The best way to tell what stage a cancer is in is computed tomography. This is also called CT. But it does not always give the best images of the bladder. Adding a test called positron emission tomography (PET) can help. Magnetic resonance imaging (MRI) is even better than CT for detecting bladder cancer. But it is not widely used. Some people with bladder cancer have already had MRI/PET and CT. Researchers want to study their records. They want to compare the different ways of assessing the disease. Objective: To evaluate the use of MRI/PET for diagnosing and treating metastatic bladder cancer. Eligibility: People 18 years and older who were in studies between 2013 and 2016 Design: Researchers will study existing records. There will be no active participants. The records will have no data that could identify the participants. Data will be stored on secure computers. No study participants will be contacted without approval from a review board.

Description:

This protocol is a chart review of the diagnostic imaging and management of patients with metastatic bladder cancer who have undergone PET MRI. The study will involve only review of patient records and will not use specimens or participant contact. The participants whose records will be reviewed in this protocol were enrolled on a number of different protocols between 2013 and 2016.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 16, 2018
• Est. primary completion date: February 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• INCLUSION CRITERIA:

Patients with metastatic bladder cancer seen between 2013 and 2016 at the NIH Clinical Center. EXCLUSION CRITERIA: Patients who opted out of storage of specimens/data for future use on prior studies will be excluded from this study.

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Locations

Country	Name	City	State
United States	National Cancer Institute (NCI)	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease burden	Comparison of measure of disease burden by PET/MRI versus traditional CT imaging	1 year