Trial Outcomes & Findings for Hysteroscopic Lymphatic Mapping for Endometrial Cancer (NCT NCT00671606)

Results Overview

Feasibility of sentinel node identification rate using intraoperative hysteroscopic injection of patent blue dye and radiocolloid for the detection of sentinel lymph nodes in patients with endometrial cancer. Sentinel node identification before and during surgery using a gamma counter to identify lymph nodes that have absorbed Tc-99m sulfur colloid. Study feasibility assessed with enrollment of 20 participants, approximately 1 year.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

15-20 minute procedure prior to/during routine surgery for identifying the sentinel nodes

Results posted on

2016-05-27

Participant Flow

Recruitment period: 4/28/2008 to 5/4/2010. All participants were recruited at UT MD Anderson Cancer Center.

Participant milestones

Participant milestones
Measure	Intraoperative Lymphatic Mapping Intraoperative sentinel lymph node identification (lymphatic mapping)
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hysteroscopic Lymphatic Mapping for Endometrial Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intraoperative Lymphatic Mapping n=5 Participants Intraoperative sentinel lymph node identification (lymphatic mapping)
Age, Continuous	56 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 15-20 minute procedure prior to/during routine surgery for identifying the sentinel nodes

Population: Analysis was per protocol; no analysis conducted due to low detection rate.

Feasibility of sentinel node identification rate using intraoperative hysteroscopic injection of patent blue dye and radiocolloid for the detection of sentinel lymph nodes in patients with endometrial cancer. Sentinel node identification before and during surgery using a gamma counter to identify lymph nodes that have absorbed Tc-99m sulfur colloid. Study feasibility assessed with enrollment of 20 participants, approximately 1 year.

Outcome measures

Outcome data not reported

Adverse Events

Intraoperative Lymphatic Mapping

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michael Frumovitz, ND/Assistant Professor

UT MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place