Assessing Uterine Ultrasound Done as a Diagnostic Tool for the Depth of Carcinoma Invasion

NCT02407535 | Completed

• 1 other identifier: CMC-14-0059-CTIL
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

In this study the investigators aim to assess the diagnostic performance of intraoperative, ultrasonographic assessment of the surgical extracted uterus for determining myometrial invasion's depth in comparison to preoperative ultrasound, intraoperative gross inspection and final pathological report (gold standard). The investigators hope that intraoperative gross inspection of the extracted uterus might offer an additional intraoperative tool for assessing the need for pelvic lymphadenectomy in early stage of endometrial cancer at least as good as pathological exam.

Conditions

Endometrial Endometroid Carcinoma

Outcome Measures

Primary Outcomes (1)

• Tumor invasion

  Tumor invasion (in millimeters and in percentage of myometrial size) as assessed by ultrasound in comparison to macroscopic assesment during surgery and to final pathological report)

  Average of 2 weeks (immediate assessment by ultrasound, average of 2 weeks for final pathological report)

Study Arms (1)

Endometrial carcinoma patient

EXPERIMENTAL

Device: Intraoperative ultrasound

Interventions

Intraoperative ultrasound DEVICE

Diagnostic intraoperative ultrasound in the uterus after hysterectomy for assessing depth of tumor invasion

Endometrial carcinoma patient

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient's age is 18 or above
• Patient has been scheduled to undergo hysterectomy (laparoscopic or abdominal) for the staging and treatment of endometrial cancer (endometrioid subtype) and with the relevant suspected symptoms.
• Patient able to understand,read and sign informed consent.
• Patient is not participating in other medical trials at present or in the past 30 days

You may not qualify if:

• Age under 18 years
• Patients assessed preoperatively to be at stage 2 and higher endometrial carcinoma
• Subjects which their biopsy in the pre operating process will include high risk cell types:
• Grade 3 endometrioid adenocarcinoma,
• clear cell carcinoma
• papillary serous carcinoma
• carcinosarcoma

Sponsors & Collaborators

• Carmel Medical Center: lead

Study Sites (1)

Carmel Medical Center

Haifa, Israel

Location

Study Officials

• Ido Feferkorn, MD

  Carmel Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 12, 2015
• First Posted: April 3, 2015
• Study Start: March 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: July 20, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)