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

NCT03327883 | Completed

• 2 other identifiers: 99991800918-C-N009
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bladder Cancer

Keywords

Diagnostic Imaging; Review of Patients Records; PET MRI; Treatment Responses

Outcome Measures

Primary Outcomes (1)

• Disease burden

  Comparison of measure of disease burden by PET/MRI versus traditional CT imaging

  1 year

Study Arms (1)

1/Patients medical records

Medical records of patients with metastatic bladder cancer

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

Medical records from patients with metastatic bladder cancer seen between 2013 and 2016 at the NIH Clinical Center. Protocols from which research data originated are 01C0129, 12C0205, 13C0063, and 15C0160.@@@

You may qualify if:

• Patients with metastatic bladder cancer seen between 2013 and 2016 at the NIH Clinical Center.

You may not qualify if:

• Patients who opted out of storage of specimens/data for future use on prior studies will be excluded from this study.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Andrea B Apolo, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: November 1, 2017
• Study Start: October 26, 2017
• Primary Completion: February 15, 2018
• Study Completion: October 16, 2018
• Last Updated: July 9, 2021

Record last verified: 2021-07

Locations

US (1)