Optical Coherence Tomography in Staging Patients With Upper Tract Urothelial Cancer

NCT ID: NCT02108587

Last Updated: 2016-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Brief Summary

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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.

Detailed Description

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PRIMARY OBJECTIVES:

I. 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.

Conditions

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Kidney/Urinary Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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optical coherence tomography for diagnosis

Patients undergo optical coherence tomography over 10-15 minutes.

Group Type EXPERIMENTAL

optical coherence tomography

Intervention Type DEVICE

Undergo optical coherence tomography

Interventions

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optical coherence tomography

Undergo optical coherence tomography

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Donald Bodner, MD

Role: PRINCIPAL_INVESTIGATOR

Case Comprehensive Cancer Center

Other Identifiers

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NCI-2014-00347

Identifier Type: REGISTRY

Identifier Source: secondary_id

CASE 11811

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CASE11811

Identifier Type: -

Identifier Source: org_study_id

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