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
Conditions
Endometrial Cancer - Uterine Cancer - Cervical Cancer
Conditions: official terms
Uterine Cervical Neoplasms - Uterine Neoplasms
Conditions: Keywords
Sentinel lymph node mapping, Endometrial cancer, Uterine cancer, Cervical cancer
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: PINPOINT
Type: Device
Overall Status
Not yet recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

- 18 years of age or older

- Patients with FIGO Clinical Stage I endometrial cancer undergoing minimally invasive hysterectomy with lymph node mapping

- Patients with FIGO Clinical Stage I cervical cancer < 2 cm in size undergoing minimally invasive hysterectomy, trachelectomy, or conization with lymph node mapping

- Patients with negative nodal status (N0)

- Patients 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 > 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 Isosulfan blue or triphenylmethane

- Hepatic dysfunction defined as MELD Score > 10

- 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 female

- 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
Location
Start Date
August 2015
Completion Date
August 2016
Sponsors
Novadaq Technologies Inc.
Source
Novadaq Technologies Inc.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page