Trial Outcomes & Findings for Efficacy of Gamma Camera Used Intraoperatively for ID of Sentinel Lymph Nodes w/ Lymphoscintigraphy (NCT NCT01314963)

Last Updated: 2018-04-30

Results Overview

Relative node detection sensitivity (S) was defined as the proportion of sentinel lymph nodes (SLNs) that were identified with each instrument, with the proportion determined as the number of true positives (TP) divided by the total evaluated (N). The outcome result is expressed as the percentage for each device with 95% confidence intervals.

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

1 day

Results posted on

2018-04-30

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants This study evaluates the ability of 2 procedures to detect sentinel lymph nodes (SLNs), and does not evaluate between groups of participants.
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Gamma Camera Used Intraoperatively for ID of Sentinel Lymph Nodes w/ Lymphoscintigraphy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=50 Participants This study evaluates the ability of 2 procedures to detect sentinel lymph nodes (SLNs), and does not evaluate between groups of participants.
Age, Customized 18 years old or greater	50 Participants n=93 Participants
Sex: Female, Male Female	27 Participants n=93 Participants
Sex: Female, Male Male	23 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	50 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	50 Participants n=93 Participants
Region of Enrollment United States	50 Participants n=93 Participants

PRIMARY outcome

Timeframe: 1 day

Population: Sentinel lymph nodes (SLNs) were evaluated for detection by the 2 methods.

Outcome measures

Outcome measures
Measure	Intraoperative Handheld Gamma Camera (pIHGC) n=104 Sentinel lymph nodes (SLNs) The prototype intraoperative handheld gamma camera (pIHGC) radioactive Tc99M: Lymphoscintigraphy involves injection of 0.4 to 1.0 mCi of radioactive Tc99M sulfur colloid around at the tumor site.	Gamma Probes (GP) n=104 Sentinel lymph nodes (SLNs) Lymphoscintigraphy with standard of care intraoperative gamma probes (GP) radioactive Tc99M: Lymphoscintigraphy involves injection of 0.4 to 1.0 mCi of radioactive Tc99M sulfur colloid around at the tumor site.
Relative Node Detection Sensitivity	88.5 Percentage (%) of SLNs detected Interval 82.3 to 94.6	94.2 Percentage (%) of SLNs detected Interval 89.7 to 98.7

Adverse Events

All Participants - Intraoperative Handheld Gamma Camera (pIHGC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

All Participants - Gamma Probes (GP)

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

Craig Levin, PhD; Professor of Radiology (Molecular Imaging Program at Stanford/Nuclear Medicine)

Stanford Univeristy Medical Center

Phone: 650-736-0449

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place