Clinical trial NCT02209532: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Cancer
Uterine Cancer
Cervical Cancer
Keywords: Lymph node mapping
Endometrial cancer
Uterine cancer
Cervical cancer
Lead sponsor: Novadaq Technologies ULC, now a part of Stryker
Sponsor class: INDUSTRY
First posted: 2014-08-06
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Effectiveness of PINPOINT and IC2000 in the Identification of Lymph Nodes Defined as the Proportion of Confirmed Lymph Nodes Identified
timeFrame: Day 0
Secondary outcomes:
measure: 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
timeFrame: Day 0
measure: 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.
timeFrame: Day 0
measure: 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.
timeFrame: Day 0
measure: Safety of Interstitial Injection of ICG Defined as the Number of Adverse Effects Related to ICG
timeFrame: Day 0 to Day 30
measure: Anatomic Distribution of Lymph Nodes
timeFrame: Day 0
Other outcomes:
Locations:
city: San Jose
country: United States
facility: O'Connor Hospital
state: California
city: Fort Myers
country: United States
facility: Lee Memorial Hospital
state: Florida
city: New York
country: United States
facility: Memorial Sloan Kettering
state: New York
city: Durham
country: United States
facility: Duke Cancer Institute
state: North Carolina
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Toronto
country: Canada
facility: Sunnybrook Health Science Centre
state: Ontario
city: Quebec City
country: Canada
facility: CHU de Québec - Université Laval
state: Quebec
city: Caguas
country: Puerto Rico
facility: Hospital HIMA San Pablo
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Michael Frumovitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frumovitz M, Plante M, Lee PS, Sandadi S, Lilja JF, Escobar PF, Gien LT, Urbauer DL, Abu-Rustum NR. Near-infrared fluorescence for detection of sentinel lymph nodes in women with cervical and uterine cancers (FILM): a randomised, phase 3, multicentre, non-inferiority trial. Lancet Oncol. 2018 Oct;19(10):1394-1403. doi: 10.1016/S1470-2045(18)30448-0. Epub 2018 Aug 22.