Trial Outcomes & Findings for Feasibility of One-Step Sentinel Lymph Node (SLN) Biopsy With Radiolabeled Methylene Blue (IND 70,627) (NCT NCT00784849)

NCT ID: NCT00784849

Last Updated: 2012-06-20

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 62 participants
• Primary outcome timeframe: intraoperatively; up to 6 hours
• Results posted on: 2012-06-20

Participant Flow

Participant milestones

Measure	Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes
Overall Study STARTED	62
Overall Study COMPLETED	62
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Feasibility of One-Step Sentinel Lymph Node (SLN) Biopsy With Radiolabeled Methylene Blue (IND 70,627)

Baseline characteristics by cohort

Measure	Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue n=62 Participants One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	55 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Sex: Female, Male Female	62 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	62 participants n=5 Participants

PRIMARY outcome

Timeframe: intraoperatively; up to 6 hours

Outcome measures

Measure	Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue n=62 Participants One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes
The Number of Participants That Have Sentinel Nodes Which Are Radioactive or Blue, or Radioactive and Blue or Have Efferent Blue Lymphatics Leading up to the Sentinel Node(s) Radioactive	58 participants
The Number of Participants That Have Sentinel Nodes Which Are Radioactive or Blue, or Radioactive and Blue or Have Efferent Blue Lymphatics Leading up to the Sentinel Node(s) Blue	55 participants
The Number of Participants That Have Sentinel Nodes Which Are Radioactive or Blue, or Radioactive and Blue or Have Efferent Blue Lymphatics Leading up to the Sentinel Node(s) Radioactive and Blue	55 participants
The Number of Participants That Have Sentinel Nodes Which Are Radioactive or Blue, or Radioactive and Blue or Have Efferent Blue Lymphatics Leading up to the Sentinel Node(s) Efferent blue lymphatics leading up to the SLN	0 participants

SECONDARY outcome

Timeframe: intraoperatively up to 6 hours

number of participants who had a systemic allergic reaction such as hives, shortness of breath, hypotension

Outcome measures

Measure	Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue n=62 Participants One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes
Safety (Allergic Reaction to Blue Dye)	0 participants

SECONDARY outcome

Timeframe: 2 weeks postoperatively

the number of participants who developed post-operative skin necrosis within 2 weeks of surgery

Outcome measures

Measure	Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue n=62 Participants One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes
Superficial Skin Necrosis	2 participants

Adverse Events

Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue n=62 participants at risk One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes
Skin and subcutaneous tissue disorders superficial skin necrosis	3.2% 2/62 • Number of events 2

Additional Information

Dr. Eugene Woltering

LSU Dept of Surgery

Phone: 504 464-8500

Email: ewolte@lsuhsc.edu

Results disclosure agreements

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