Optical Coherence Tomography in Staging Patients With Upper Tract Urothelial Cancer

Sponsor

Case Comprehensive Cancer Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02108587

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Arm

Study Details

Study Description

Brief Summary

This clinical trial studies how well optical coherence tomography works in staging patients with upper-tract urothelial carcinomas. Staging describes the severity of a person's cancer based on the size and/or extent (reach) of the original (primary) tumor and whether or not cancer has spread in the body. It also helps the doctor plan the appropriate treatment. Optical coherence tomography is a procedure that uses infrared light waves to give three-dimensional pictures of structures inside tissues and organs. The pictures are made by a computer linked to the light source. Optical coherence tomography may be effective in staging patients with upper-tract urothelial carcinomas.

Condition or Disease	Intervention/Treatment	Phase
Kidney/Urinary Cancer	Device: optical coherence tomography	N/A

Detailed Description

PRIMARY OBJECTIVES:

To test the feasibility and imaging ability of optical coherence tomography (OCT) to stage upper-tract urothelial carcinomas (UTUC).

OUTLINE:

Patients undergo optical coherence tomography over 10-15 minutes.

After completion of study, patients are followed up at 3 months.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Staging of Upper Tract Urothelial Cancer With Optical Coherence Tomography

Study Start Date :

Dec 1, 2016

Anticipated Primary Completion Date :

Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: optical coherence tomography for diagnosis Patients undergo optical coherence tomography over 10-15 minutes.	Device: optical coherence tomography Undergo optical coherence tomography

Arm

Intervention/Treatment

Experimental: optical coherence tomography for diagnosis

Patients undergo optical coherence tomography over 10-15 minutes.

Device: optical coherence tomography

Undergo optical coherence tomography

Outcome Measures

Primary Outcome Measures

Feasibility of optical coherence tomography (OCT) images in staging upper-tract urothelial carcinomas (UTUC) [Up to 3 months]
Feasibility defined as the ability to relate the features associated with cancerous tissues in pathohistological analysis to the features in OCT images

Secondary Outcome Measures

Imaging Analysis [Up to 3 months]
Number of cancerous images with at least one feature different from normal pathology slide

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients must have radiographic evidence of upper tract urothelial cancer by computed tomography (CT), magnetic resonance imaging (MRI) or intravenous pyelogram (IVP) in order to undergo this procedure
Patient who will undergo standard of care clinical staging for UTUC
Patient ability to read and comprehend the informed consent document

Exclusion Criteria:

Patient who has a contraindication to endoscopy
Patient who is pregnant

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Case Comprehensive Cancer Center
National Cancer Institute (NCI)

Investigators

Principal Investigator: Donald Bodner, MD, Case Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Case Comprehensive Cancer Center

ClinicalTrials.gov Identifier:

NCT02108587

Other Study ID Numbers:

CASE11811
NCI-2014-00347
CASE 11811
P30CA043703

First Posted:

Apr 9, 2014

Last Update Posted:

Oct 20, 2016

Last Verified:

Oct 1, 2016

Study Results

No Results Posted as of Oct 20, 2016