Trial Outcomes & Findings for A Study Comparing Green Fluorescent Dye and Radioactive Dye for Sentinel Lymph Node Biopsy in Pediatric Cancers (NCT NCT02910726)

NCT ID: NCT02910726

Last Updated: 2022-10-05

Results Overview

These percentages will be compared using a non-inferiority comparison for matched pair data.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 6 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2022-10-05

Participant Flow

Participant milestones

Measure	Sentinel Lymph Node Biopsy This is a single-center clinical trial to evaluate non-inferiority of ICG-guided SLN biopsy compared with the gold standard TcL-guided SLN biopsy in pediatric patients with solid tumors. Each patient will undergo TcL, consistent with the standard of care, but the surgeon will be blinded to the results preoperatively. Intraoperatively, ICG injection and transdermal lymphography will be used to identify the draining nodal basin and the position of the sentinel nodes. ICG transdermal lymphography will be considered successful if SLNs can be visualized on near-infrared imaging. After the transdermal lymphography results have been recorded, the surgeon will be unblinded to the TcL mapping. Sentinel Lymph Node Biopsy indocyanine green (ICG)
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study Comparing Green Fluorescent Dye and Radioactive Dye for Sentinel Lymph Node Biopsy in Pediatric Cancers

Baseline characteristics by cohort

Measure	Sentinel Lymph Node Biopsy n=6 Participants This is a single-center clinical trial to evaluate non-inferiority of ICG-guided SLN biopsy compared with the gold standard TcL-guided SLN biopsy in pediatric patients with solid tumors. Each patient will undergo TcL, consistent with the standard of care, but the surgeon will be blinded to the results preoperatively. Intraoperatively, ICG injection and transdermal lymphography will be used to identify the draining nodal basin and the position of the sentinel nodes. ICG transdermal lymphography will be considered successful if SLNs can be visualized on near-infrared imaging. After the transdermal lymphography results have been recorded, the surgeon will be unblinded to the TcL mapping. Sentinel Lymph Node Biopsy indocyanine green (ICG)
Age, Continuous	15 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: N/A - data were not collected

These percentages will be compared using a non-inferiority comparison for matched pair data.

Outcome measures

Outcome data not reported

Adverse Events

Sentinel Lymph Node Biopsy

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

Neeta Pandit-Taskar, MD

Memorial Sloan Kettering Cancer Center

Phone: 1-833-MSK-KIDS

Email: pandit-n@mskcc.org

Results disclosure agreements

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