The Development of an In-vitro System to Identify Gynecologic Cancer Cells During Surgical Procedures

Sponsor

Hillel Yaffe Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT02718209

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to examine the efficacy of mid-infrared spectroscopy together with Attenuated Total Reflection (ATR), for the detection of gynecological malignancies in real time during surgery.

Condition or Disease	Intervention/Treatment	Phase
Gynecological Malignancies	Device: Mid-Infrared Spectroscopy with ATR	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Study Start Date :

Apr 1, 2016

Anticipated Primary Completion Date :

Apr 1, 2018

Anticipated Study Completion Date :

Apr 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Frozen section Frozen sections taken from women operated on for possible gynecologic malignancies.	Device: Mid-Infrared Spectroscopy with ATR

Arm

Intervention/Treatment

Experimental: Frozen section

Frozen sections taken from women operated on for possible gynecologic malignancies.

Device: Mid-Infrared Spectroscopy with ATR

Outcome Measures

Primary Outcome Measures

Gynecological Malignancies Identified in Real Time [One hour]
Results of Spectroscopy will be compared to frozen section/histopathology findings

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Women with one or more tumors in reproductive system

Exclusion Criteria:

Pregnant women
Unable to give consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hillel Yaffe Medical Center	Hadera		Israel	38100

Sponsors and Collaborators

Hillel Yaffe Medical Center

Investigators

Principal Investigator: Ilan Bruchim, MD, Hillel Yaffe Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hillel Yaffe Medical Center

ClinicalTrials.gov Identifier:

NCT02718209

Other Study ID Numbers:

HYMC-84-15

First Posted:

Mar 24, 2016

Last Update Posted:

Mar 24, 2016

Last Verified:

Mar 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Mar 24, 2016