Trial Outcomes & Findings for Determining the Sensitivity of Sentinel Lymph Nodes Identified With Robotic Fluorescence Imaging (NCT NCT01673022)

Last Updated: 2018-07-24

Results Overview

To estimate the sensitivity of the sentinel lymph node in the determination of lymph node metastases in patients with invasive carcinoma of the cervix and uterus using Indocyanine Green (ICG) and robotic assisted near infrared (NIR) imaging. Sensitivity is defined as the proportion of sentinel lymph node: number of participants with, determined to be metastatic by both IGR/NIR and pathology out of the sentinel lymph nodes found to be metastatic by pathology.

Recruitment status

COMPLETED

Study phase

Target enrollment

430 participants

Primary outcome timeframe

3 years

Results posted on

2018-07-24

Participant Flow

Participant milestones

Participant milestones
Measure	IC-GREEN® (Indocyanine Green) Arm One arm only: Receives IC-GREEN® (Indocyanine green) for testing of study objective IC-GREEN®: Indocyanine green
Overall Study STARTED	430
Overall Study COMPLETED	422
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Determining the Sensitivity of Sentinel Lymph Nodes Identified With Robotic Fluorescence Imaging

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IC Green Arm n=430 Participants One arm only: Receives IC Green for testing of study objective IC Green: IC Green
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	293 Participants n=5 Participants
Age, Categorical >=65 years	137 Participants n=5 Participants
Age, Continuous	51 years STANDARD_DEVIATION 28 • n=5 Participants
Sex: Female, Male Female	430 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	430 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years

Population: Sensitivity of the sentinel lymph node

Outcome measures

Outcome measures
Measure	IC Green (Indocyanine Green) Arm n=430 Participants One arm only: Receives IC Green (indocyanine green) )for testing of study objective IC Green: IC Green (indocyanine green)
Estimate the Sensitivity of the Sentinel Lymph Node	418 Participants

Adverse Events

IC Green Arm

Serious events: 22 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	IC Green Arm n=430 participants at risk One arm only: Receives IC Green for testing of study objective IC Green: IC Green
Respiratory, thoracic and mediastinal disorders postoperative respiratory distress	0.93% 4/430
Nervous system disorders postoperative neurological disorder	0.93% 4/430
Renal and urinary disorders ureteral injury	0.23% 1/430
Gastrointestinal disorders nausea	1.2% 5/430
Surgical and medical procedures pain	0.93% 4/430
Blood and lymphatic system disorders anemia	0.23% 1/430
Cardiac disorders syncope	0.23% 1/430
Skin and subcutaneous tissue disorders lymphedema	0.23% 1/430
Surgical and medical procedures hemorrhage	0.23% 1/430

Other adverse events

Other adverse events
Measure	IC Green Arm n=430 participants at risk One arm only: Receives IC Green for testing of study objective IC Green: IC Green
Surgical and medical procedures abdominal pain	0.70% 3/430
Blood and lymphatic system disorders hypokalemia	0.47% 2/430
Respiratory, thoracic and mediastinal disorders pulmonary edema	0.23% 1/430
Cardiac disorders hypertension	0.23% 1/430
Cardiac disorders hypotension	0.47% 2/430
Nervous system disorders dizziness	0.23% 1/430
Metabolism and nutrition disorders hyperglycemia	0.23% 1/430
Infections and infestations fever	0.70% 3/430
Blood and lymphatic system disorders anemia	0.47% 2/430
Gastrointestinal disorders nausea	0.23% 1/430

Additional Information

Research Coordinator

Indiana University School of Medicine

Phone: 317-944-2654

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place