NCT02108587

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.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2014

Completed
2.6 years until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Last Updated

October 20, 2016

Status Verified

October 1, 2016

Enrollment Period

3 months

First QC Date

April 7, 2014

Last Update Submit

October 19, 2016

Conditions

Kidney/Urinary Cancer

Outcome Measures

Primary Outcomes (1)

  • Feasibility of optical coherence tomography (OCT) images in staging upper-tract urothelial carcinomas (UTUC)

    Feasibility defined as the ability to relate the features associated with cancerous tissues in pathohistological analysis to the features in OCT images

    Up to 3 months

Secondary Outcomes (1)

  • Imaging Analysis

    Up to 3 months

Study Arms (1)

optical coherence tomography for diagnosis

EXPERIMENTAL

Patients undergo optical coherence tomography over 10-15 minutes.

Device: optical coherence tomography

Interventions

optical coherence tomographyDEVICE

Undergo optical coherence tomography

optical coherence tomography for diagnosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patient who has a contraindication to endoscopy
  • Patient who is pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urologic Neoplasms

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Urogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrologic Diseases

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Officials

  • Donald Bodner, MD

    Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2014

First Posted

April 9, 2014

Study Start

December 1, 2016

Primary Completion

March 1, 2017

Last Updated

October 20, 2016

Record last verified: 2016-10