Brief Title
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
Official Title
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
Brief Summary
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.
Study Type
Interventional
Primary Outcome
Effectiveness of PINPOINT and IC2000 in the Identification of Lymph Nodes Defined as the Proportion of Confirmed Lymph Nodes Identified
Secondary Outcome
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
Condition
Endometrial Cancer
Intervention
PINPOINT
Study Arms / Comparison Groups
Blue - PINPOINT
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
180
Start Date
December 2015
Completion Date
June 2017
Primary Completion Date
June 2017
Eligibility Criteria
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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Michael Frumovitz, MD, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT02209532
Organization ID
PP LNM 01
Responsible Party
Sponsor
Study Sponsor
Novadaq Technologies ULC, now a part of Stryker
Study Sponsor
Michael Frumovitz, MD, Principal Investigator, M.D. Anderson Cancer Center
Verification Date
March 2019