Trial Outcomes & Findings for A Study Assessing the Safety and Utility of PINPOINT® Near Infrared Fluorescence Imaging in the Identification of Lymph Nodes in Patients With Uterine and Cervical Malignancies Who Are Undergoing Lymph Node Mapping (NCT NCT02209532)

NCT ID: NCT02209532

Last Updated: 2019-03-25

Results Overview

To assess the effectiveness of intraoperative PINPOINT Near Infrared Fluorescence Imaging in the identification of lymph nodes in subjects with uterine and cervical malignancies who are undergoing lymph node mapping.

Recruitment status

COMPLETED

Study phase

Target enrollment

180 participants

Primary outcome timeframe

Day 0

Results posted on

2019-03-25

Participant Flow

Participant milestones

Participant milestones
Measure	Lymph Node Mapping With Isosulfan Blue Followed by PINPOINT The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised. PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes	Lymph Node Mapping With PINPOINT Followed by Isosulfan Blue The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised. PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
Overall Study STARTED	90	90
Overall Study COMPLETED	87	89
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study Assessing the Safety and Utility of PINPOINT® Near Infrared Fluorescence Imaging in the Identification of Lymph Nodes in Patients With Uterine and Cervical Malignancies Who Are Undergoing Lymph Node Mapping

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Blue - PINPOINT n=87 Participants The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised. PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes	PINPOINT - Blue n=89 Participants The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised. PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes	Total n=176 Participants Total of all reporting groups
Age, Customized 30-39	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Age, Customized 40-49	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Age, Customized 50-59	20 Participants n=5 Participants	26 Participants n=7 Participants	46 Participants n=5 Participants
Age, Customized 60-69	33 Participants n=5 Participants	41 Participants n=7 Participants	74 Participants n=5 Participants
Age, Customized 70-79	20 Participants n=5 Participants	12 Participants n=7 Participants	32 Participants n=5 Participants
Age, Customized >80	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Sex/Gender, Customized Female	87 Participants n=5 Participants	89 Participants n=7 Participants	176 Participants n=5 Participants
Race/Ethnicity, Customized White	66 Participants n=5 Participants	73 Participants n=7 Participants	139 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Smoking Status Never	66 Participants n=5 Participants	65 Participants n=7 Participants	131 Participants n=5 Participants
Smoking Status Current	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Smoking Status Past	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Alcohol Consumption Yes	34 Participants n=5 Participants	31 Participants n=7 Participants	65 Participants n=5 Participants
Alcohol Consumption No	53 Participants n=5 Participants	58 Participants n=7 Participants	111 Participants n=5 Participants
ASA Classification I - A normal healthy patient	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
ASA Classification II - A patient with mild systemic disease	38 Participants n=5 Participants	39 Participants n=7 Participants	77 Participants n=5 Participants
ASA Classification III - A patient with severe systemic disease	34 Participants n=5 Participants	32 Participants n=7 Participants	66 Participants n=5 Participants
ASA Classification Unknown ASA Classification	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Preoperative Diagnosis Stage 1 Endometrial Cancer	84 Participants n=5 Participants	85 Participants n=7 Participants	169 Participants n=5 Participants
Preoperative Diagnosis Stage 1 Cervical Cancer	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Preoperative Diagnosis Stage 1A Cervical Cancer	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Endometrial Cancer Histology Adenocarcinoma	71 Participants n=5 Participants	75 Participants n=7 Participants	146 Participants n=5 Participants
Endometrial Cancer Histology Serous Carcinoma	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Endometrial Cancer Histology Clear Cell Carcinoma	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Endometrial Cancer Histology Carcinosarcoma	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Endometrial Cancer Histology Other	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Cervical Cancer Histology Squamous Cell Carcinoma	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Cervical Cancer Histology Adenocarcinoma	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0

Population: All analyses were completed using the number of lymph nodes identified.

Outcome measures

Outcome measures
Measure	PINPOINT - Blue n=238 Confirmed Lymph Nodes The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised. PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes	Blue - PINPOINT n=247 Confirmed Lymph Nodes The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised. PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
Effectiveness of PINPOINT and IC2000 in the Identification of Lymph Nodes Defined as the Proportion of Confirmed Lymph Nodes Identified	232 Confirmed Lymph Nodes	239 Confirmed Lymph Nodes

SECONDARY outcome

Timeframe: Day 0

Population: 180 subjects were randomized. 4 subjects were found to be ineligible after randomization (subjects did not receive study treatment). Of the 176 subjects randomized who completed the study, 13 had significant protocol deviations. Thus, 163 subjects are included in the analysis population (81 subjects in the B-P arm and 82 subjects in the P-B arm).

To evaluate the effectiveness of PINPOINT and Blue dye in the identification of at least one lymph node (confirmed to be lymphoid tissue) per subject.

Outcome measures

Outcome measures
Measure	PINPOINT - Blue n=82 Participants The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised. PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes	Blue - PINPOINT n=81 Participants The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised. PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
Effectiveness of PINPOINT and Blue Dye in the Identification of at Least One Lymph Node Defined as the Number of Subjects in Which at Least One Confirmed Lymph Node Was Identified With Either PINPOINT or Blue Dye IC2000 and PINPOINT	80 Number of Subjects	79 Number of Subjects
Effectiveness of PINPOINT and Blue Dye in the Identification of at Least One Lymph Node Defined as the Number of Subjects in Which at Least One Confirmed Lymph Node Was Identified With Either PINPOINT or Blue Dye Isosulfan Blue	64 Number of Subjects	60 Number of Subjects

SECONDARY outcome

Timeframe: Day 0

To evaluate the effectiveness of PINPOINT and Blue dye in the identification of bilateral lymph nodes (confirmed to be lymphoid tissue).

Outcome measures

Outcome measures
Measure	PINPOINT - Blue n=82 Participants The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised. PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes	Blue - PINPOINT n=81 Participants The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised. PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
Effectiveness of PINPOINT and Blue Dye in the Identification of Bilateral Lymph Nodes Defined as the Number of Subjects in Which Lymph Nodes Were Identified Bilaterally With Either PINPOINT or Blue Dye. IC2000 and PINPOINT	64 Number of Subjects	60 Number of Subjects
Effectiveness of PINPOINT and Blue Dye in the Identification of Bilateral Lymph Nodes Defined as the Number of Subjects in Which Lymph Nodes Were Identified Bilaterally With Either PINPOINT or Blue Dye. Isosulfan Blue	24 Number of Subjects	25 Number of Subjects

SECONDARY outcome

Timeframe: Day 0

To determine the proportion of lymph nodes identified from following lymphatic channels

Outcome measures

Outcome measures
Measure	PINPOINT - Blue n=82 Participants The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised. PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes	Blue - PINPOINT n=81 Participants The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised. PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
Identification of Lymph Nodes Following Lymphatic Channels Defined as the Number of Subjects in Which Confirmed Lymph Nodes Were Identified by Following a Lymphatic Channel With Either PINPOINT or Blue Dye. IC2000 and PINPOINT	6 Number of Subjects	3 Number of Subjects
Identification of Lymph Nodes Following Lymphatic Channels Defined as the Number of Subjects in Which Confirmed Lymph Nodes Were Identified by Following a Lymphatic Channel With Either PINPOINT or Blue Dye. Isosulfan Blue	8 Number of Subjects	6 Number of Subjects

SECONDARY outcome

Timeframe: Day 0 to Day 30

To assess the safety of interstitial injection of ICG for intraoperative lymphatic mapping, as measured by number of subjects experiencing adverse effects related to the study treatment.

Outcome measures

Outcome measures
Measure	PINPOINT - Blue n=89 Participants The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised. PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes	Blue - PINPOINT n=87 Participants The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised. PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
Safety of Interstitial Injection of ICG Defined as the Number of Adverse Effects Related to ICG	0 Number of subjects	0 Number of subjects

SECONDARY outcome

Timeframe: Day 0

To determine the anatomic distribution of lymph nodes

Outcome measures

Outcome measures
Measure	PINPOINT - Blue n=232 Lymph Nodes The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised. PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes	Blue - PINPOINT n=239 Lymph Nodes The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised. PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
Anatomic Distribution of Lymph Nodes Left obturator/internal iliac	28 confirmed lymph nodes	36 confirmed lymph nodes
Anatomic Distribution of Lymph Nodes Left external iliac	69 confirmed lymph nodes	67 confirmed lymph nodes
Anatomic Distribution of Lymph Nodes Left common iliac	11 confirmed lymph nodes	6 confirmed lymph nodes
Anatomic Distribution of Lymph Nodes Right obturator/internal iliac	39 confirmed lymph nodes	45 confirmed lymph nodes
Anatomic Distribution of Lymph Nodes Right external iliac	52 confirmed lymph nodes	50 confirmed lymph nodes
Anatomic Distribution of Lymph Nodes Right common iliac	17 confirmed lymph nodes	18 confirmed lymph nodes
Anatomic Distribution of Lymph Nodes Presacral	2 confirmed lymph nodes	5 confirmed lymph nodes
Anatomic Distribution of Lymph Nodes Para-aortic node below IMA	4 confirmed lymph nodes	5 confirmed lymph nodes
Anatomic Distribution of Lymph Nodes Other	10 confirmed lymph nodes	7 confirmed lymph nodes

Adverse Events

Blue - PINPOINT

Serious events: 4 serious events

Other events: 13 other events

Deaths: 0 deaths

PINPOINT - Blue

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Blue - PINPOINT n=87 participants at risk The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised. PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes	PINPOINT - Blue n=89 participants at risk The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised. PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
Gastrointestinal disorders Partial bowel obstruction	1.1% 1/87 • 30 Days Adverse Events were not monitored/assessed for each intervention separately. Both interventions (ICG/PINPOINT and Isosulfan Blue) were administered at the time of the adverse events.	0.00% 0/89 • 30 Days Adverse Events were not monitored/assessed for each intervention separately. Both interventions (ICG/PINPOINT and Isosulfan Blue) were administered at the time of the adverse events.
Respiratory, thoracic and mediastinal disorders Atelectasis	1.1% 1/87 • 30 Days Adverse Events were not monitored/assessed for each intervention separately. Both interventions (ICG/PINPOINT and Isosulfan Blue) were administered at the time of the adverse events.	0.00% 0/89 • 30 Days Adverse Events were not monitored/assessed for each intervention separately. Both interventions (ICG/PINPOINT and Isosulfan Blue) were administered at the time of the adverse events.
Respiratory, thoracic and mediastinal disorders Trace pleural effusions	1.1% 1/87 • 30 Days Adverse Events were not monitored/assessed for each intervention separately. Both interventions (ICG/PINPOINT and Isosulfan Blue) were administered at the time of the adverse events.	0.00% 0/89 • 30 Days Adverse Events were not monitored/assessed for each intervention separately. Both interventions (ICG/PINPOINT and Isosulfan Blue) were administered at the time of the adverse events.
Nervous system disorders Dizziness	1.1% 1/87 • 30 Days Adverse Events were not monitored/assessed for each intervention separately. Both interventions (ICG/PINPOINT and Isosulfan Blue) were administered at the time of the adverse events.	0.00% 0/89 • 30 Days Adverse Events were not monitored/assessed for each intervention separately. Both interventions (ICG/PINPOINT and Isosulfan Blue) were administered at the time of the adverse events.
Ear and labyrinth disorders Vertigo	0.00% 0/87 • 30 Days Adverse Events were not monitored/assessed for each intervention separately. Both interventions (ICG/PINPOINT and Isosulfan Blue) were administered at the time of the adverse events.	1.1% 1/89 • 30 Days Adverse Events were not monitored/assessed for each intervention separately. Both interventions (ICG/PINPOINT and Isosulfan Blue) were administered at the time of the adverse events.

Other adverse events

Other adverse events
Measure	Blue - PINPOINT n=87 participants at risk The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised. PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes	PINPOINT - Blue n=89 participants at risk The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised. PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
Injury, poisoning and procedural complications Procedural Pain	14.9% 13/87 • 30 Days Adverse Events were not monitored/assessed for each intervention separately. Both interventions (ICG/PINPOINT and Isosulfan Blue) were administered at the time of the adverse events.	11.2% 10/89 • 30 Days Adverse Events were not monitored/assessed for each intervention separately. Both interventions (ICG/PINPOINT and Isosulfan Blue) were administered at the time of the adverse events.
Gastrointestinal disorders Nausea	8.0% 7/87 • 30 Days Adverse Events were not monitored/assessed for each intervention separately. Both interventions (ICG/PINPOINT and Isosulfan Blue) were administered at the time of the adverse events.	4.5% 4/89 • 30 Days Adverse Events were not monitored/assessed for each intervention separately. Both interventions (ICG/PINPOINT and Isosulfan Blue) were administered at the time of the adverse events.

Additional Information

Alicia Wilton

Novadaq Technologies

Phone: 416-949-4992

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place