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

Study Overview
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Brief Summary
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This is a randomized, prospective, open label, multicenter study to assess the safety and utility of PINPOINT® Near Infrared Fluorescence Imaging (PINPOINT) in identification of lymph nodes (LN) in patients with uterine and cervical malignancies who are undergoing LN mapping.

Official Title
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A Randomized, Prospective, Open Label, Multicenter 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

Conditions
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Endometrial Cancer, Uterine Cancer, Cervical Cancer

Intervention / Treatment
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* Device: PINPOINT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Subjects with FIGO Clinical Stage I endometrial cancer undergoing minimally invasive hysterectomy with lymph node mapping. Subjects with FIGO Clinical Stage IA cervical cancer ≤ 2 cm in size undergoing minimally invasive hysterectomy, trachelectomy, or conization with lymph node mapping. Subjects with clinical Stage IA1 cervical cancer without lympho vascular space involvement (LVSI) and negative margins on cone biopsy are not to be included. Subjects with negative nodal status (N0) Subjects with negative metastatic involvement (M0). Exclusion Criteria: Have had prior dissection and/or radiation in pelvis. Advanced cervical or endometrial cancer, T3/T4 lesions Diagnosis of cervical cancer with a tumor size greater than 2 cm. Locally advanced or inflammatory cervical or uterine cancer Metastatic cervical or uterine cancer. Known allergy or history of adverse reaction to ICG, iodine or iodine dyes. Known allergy or history of adverse reaction to Blue dye (Isosulfan blue) or triphenylmethane. Hepatic dysfunction defined as MELD Score > 12. Renal dysfunction defined as serum creatinine ≥ 2.0 mg/dl. Subjects who have participated in another investigational study within 30 days prior to surgery. Pregnant or lactating subjects. Subjects who, in the Investigator's opinion, have any medical condition that makes the subject a poor candidate for the investigational procedure, or interferes with the interpretation of study results.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Blue - PINPOINT<br>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. | Device: PINPOINT<br>* PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes<br>|
| Active Comparator: PINPOINT - Blue<br>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. | Device: PINPOINT<br>* PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of PINPOINT and IC2000 in the Identification of Lymph Nodes Defined as the Proportion of Confirmed Lymph Nodes Identified | 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. | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | Day 0 | 
| 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. | To evaluate the effectiveness of PINPOINT and Blue dye in the identification of bilateral lymph nodes (confirmed to be lymphoid tissue). | Day 0 | 
| 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. | To determine the proportion of lymph nodes identified from following lymphatic channels | Day 0 | 
| Safety of Interstitial Injection of ICG Defined as the Number of Adverse Effects Related to ICG | 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. | Day 0 to Day 30 | 
| Anatomic Distribution of Lymph Nodes | To determine the anatomic distribution of lymph nodes | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometrial cancer, Lymph node mapping, Uterine cancer, Cervical cancer