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 (FILM)

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ClinicalTrials.gov Identifier: NCT02209532

Recruitment Status : Completed

First Posted : August 6, 2014

Last Update Posted : June 23, 2017

Sponsor:

Information provided by (Responsible Party):

Novadaq Technologies Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Endometrial Cancer Uterine Cancer Cervical Cancer	Device: PINPOINT	Not Applicable

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	180 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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 Start Date :	December 2015
Actual Primary Completion Date :	June 2017
Actual Study Completion Date :	June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diagnostic Imaging

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Blue - PINPOINT 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.	Device: PINPOINT PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
Active Comparator: PINPOINT - Blue The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' 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.	Device: PINPOINT PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes

Arm

Intervention/treatment

Active Comparator: Blue - PINPOINT

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.

Device: PINPOINT

PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes

Active Comparator: PINPOINT - Blue

The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' 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.

Device: PINPOINT

PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes

Outcome Measures

Primary Outcome Measures :

Identification of Lymph Nodes with PINPOINT [ Time Frame: Day 0 ]
To assess the effectiveness of intraoperative PINPOINT Near Infrared Fluorescence Imaging in the identification of lymph nodes in subjects with uterine and cervical malignancies who are undergoing lymph node mapping.

Secondary Outcome Measures :

Safety of Interstitial Injection of ICG, as measured by number of subjects experiencing adverse effects. [ Time Frame: Day 0 to Day 30 ]
To assess the safety of interstitial injection of ICG for intraoperative lymphatic mapping.
Effectiveness of PINPOINT and Blue dye to identify lymph nodes [ Time Frame: Day 0 ]
To evaluate the effectiveness of PINPOINT and Blue dye in the identification of at least one lymph node (confirmed to be lymphoid tissue) per subject.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02209532

Locations


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

Sponsors and Collaborators

Novadaq Technologies Inc.

Investigators


Principal Investigator:	Michael Frumovitz, MD	M.D. Anderson Cancer Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Novadaq Technologies Inc.
ClinicalTrials.gov Identifier:	NCT02209532 History of Changes
Other Study ID Numbers:	PP LNM 01
First Posted:	August 6, 2014 Key Record Dates
Last Update Posted:	June 23, 2017
Last Verified:	June 2017

Keywords provided by Novadaq Technologies Inc.:


Lymph node mapping Endometrial cancer Uterine cancer Cervical cancer

Additional relevant MeSH terms:


Uterine Cervical Neoplasms Endometrial Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms	Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female

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