Trial Outcomes & Findings for Comparison of Use of Indocyanine Green and 99mTc-labeled Radiotracer for Axillary Lymphatic Mapping in Patients With Breast Cancer (NCT NCT02419807)

NCT ID: NCT02419807

Last Updated: 2022-06-30

Results Overview

Let A be the number of Tc-positive and ICG-positive sentinel nodes (SNs) detected, B be the number of Tc-positive and ICG-negative SNs detected, and C be the number of Tc-negative and ICG-positive SNs detected. The total number (N) of SNs detected is therefore N = (A + B + C); the proportion of SNs detected by the Tc method (PTc) is (A + B)/N; and the proportion of SNs detected by the ICG method (PICG) is (A + C)/N. Differences in the proportions of SLNs flagged will be compared using a two-sided 95% confidence interval.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 102 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2022-06-30

Participant Flow

Participant milestones

Measure	Diagnostic (Indocyanine Green, 99mTc-labeled Radiotracer) Participants receive technetium Tc-99m sulfur colloid injection and undergo lymphoscintigraphy according to clinical practice. Prior to surgery, participants also receive indocyanine green solution subdermally close to the tumor or into subareolar region of the breast skin. Participants then undergo Axillary Lymph Node Biopsy and surgery.
Overall Study STARTED	102
Overall Study COMPLETED	92
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Measure	Diagnostic (Indocyanine Green, 99mTc-labeled Radiotracer) Participants receive technetium Tc-99m sulfur colloid injection and undergo lymphoscintigraphy according to clinical practice. Prior to surgery, participants also receive indocyanine green solution subdermally close to the tumor or into subareolar region of the breast skin. Participants then undergo Axillary Lymph Node Biopsy and surgery.
Overall Study Withdrawal by Subject	4
Overall Study Physician Decision	1
Overall Study Protocol Violation	5

Baseline Characteristics

Comparison of Use of Indocyanine Green and 99mTc-labeled Radiotracer for Axillary Lymphatic Mapping in Patients With Breast Cancer

Baseline characteristics by cohort

Measure	Diagnostic (Indocyanine Green, 99mTc-labeled Radiotracer) n=102 Participants Participants receive technetium Tc-99m sulfur colloid injection and undergo lymphoscintigraphy according to clinical practice. Prior to surgery, participants also receive indocyanine green solution subdermally close to the tumor or into subareolar region of the breast skin. Participants then undergo Axillary Lymph Node Biopsy and surgery.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	66 Participants n=5 Participants
Age, Categorical >=65 years	36 Participants n=5 Participants
Sex: Female, Male Female	102 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	96 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants
Race (NIH/OMB) White	90 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	102 participants n=5 Participants
Tc-positive and ICG-positive sentinel nodes (SNs)	191 sentinel nodes n=5 Participants
Tc-positive and ICG-negative sentinel nodes (SNs)	11 sentinel nodes n=5 Participants
Tc-negative and ICG-positive SNs	33 sentinel nodes n=5 Participants
Total sentinel lymph nodes (SLNs)	235 sentinel nodes n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Participants who completed study

Let A be the number of Tc-positive and ICG-positive sentinel nodes (SNs) detected, B be the number of Tc-positive and ICG-negative SNs detected, and C be the number of Tc-negative and ICG-positive SNs detected. The total number (N) of SNs detected is therefore N = (A + B + C); the proportion of SNs detected by the Tc method (PTc) is (A + B)/N; and the proportion of SNs detected by the ICG method (PICG) is (A + C)/N. Differences in the proportions of SLNs flagged will be compared using a two-sided 95% confidence interval.

Outcome measures

Measure	Diagnostic (Indocyanine Green, 99mTc-labeled Radiotracer) n=92 Participants Participants receive technetium Tc-99m sulfur colloid injection and undergo lymphoscintigraphy according to clinical practice. Prior to surgery, participants also receive indocyanine green solution subdermally close to the tumor or into subareolar region of the breast skin. Participants then undergo Axillary Lymph Node Biopsy and surgery.
Proportion of Sentinel Lymph Nodes (SLNs) Flagged by the Two Methods Proportion of SNs (PTc) detected by Tc method	0.86 proportion of nodes
Proportion of Sentinel Lymph Nodes (SLNs) Flagged by the Two Methods Proportion of SNs (PICG) detected by ICG method	0.95 proportion of nodes

Adverse Events

Diagnostic (Indocyanine Green, 99mTc-labeled Radiotracer)

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. Stephen Grobmyer

Cleveland Clinic, Case Comprehensive Cancer Center

Phone: 1-866-223-8100

Email: TaussigResearch@ccf.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place