Status:
COMPLETED
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
Lead Sponsor:
Novadaq Technologies ULC, now a part of Stryker
Conditions:
Endometrial Cancer
Uterine Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
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 pa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT02209532
Start Date
December 1 2015
End Date
June 1 2017
Last Update
March 25 2019
Active Locations (8)
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1
O'Connor Hospital
San Jose, California, United States
2
Lee Memorial Hospital
Fort Myers, Florida, United States
3
Memorial Sloan Kettering
New York, New York, United States
4
Duke Cancer Institute
Durham, North Carolina, United States