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

Completed · Not applicable

Conditions studied: Endometrial Cancer, Uterine Cancer, Cervical Cancer

In brief

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.

Key facts

Study ID

NCT02209532

Run by

Novadaq Technologies ULC, now a part of Stryker

People needed

180

Starts

2015-12-01

Expected to finish

2017-06-01

Last updated by the study team

2019-03-25

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• O'Connor Hospital — San Jose, California, United States
• Lee Memorial Hospital — Fort Myers, Florida, United States
• Memorial Sloan Kettering — New York, New York, United States
• Duke Cancer Institute — Durham, North Carolina, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Sunnybrook Health Science Centre — Toronto, Ontario, Canada
• CHU de Québec - Université Laval — Québec, Quebec, Canada
• Hospital HIMA San Pablo — Caguas, Puerto Rico

Full record on ClinicalTrials.gov

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