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 |
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Recruitment Status :
Completed
First Posted : August 6, 2014
Results First Posted : March 25, 2019
Last Update Posted : March 25, 2019
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Sponsor:
Novadaq Technologies ULC, now a part of Stryker
Information provided by (Responsible Party):
Novadaq Technologies ULC, now a part of Stryker
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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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 180 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover 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
| Arm | Intervention/treatment |
|---|---|
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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.
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Device: PINPOINT
PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes |
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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.
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Device: PINPOINT
PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes |
Primary Outcome Measures :
- Effectiveness of PINPOINT and IC2000 in the Identification of Lymph Nodes Defined as the Proportion of Confirmed Lymph Nodes Identified [ 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 :
- 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 [ 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.
- 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. [ Time Frame: Day 0 ]To evaluate the effectiveness of PINPOINT and Blue dye in the identification of bilateral lymph nodes (confirmed to be lymphoid tissue).
- 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. [ Time Frame: Day 0 ]To determine the proportion of lymph nodes identified from following lymphatic channels
- Safety of Interstitial Injection of ICG Defined as the Number of Adverse Effects Related to ICG [ Time Frame: Day 0 to Day 30 ]To assess the safety of interstitial injection of ICG for intraoperative lymphatic mapping, as measured by number of subjects experiencing adverse effects related to the study treatment.
- Anatomic Distribution of Lymph Nodes [ Time Frame: Day 0 ]To determine the anatomic distribution of lymph nodes
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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.
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 ULC, now a part of Stryker
Investigators
| Principal Investigator: | Michael Frumovitz, MD | M.D. Anderson Cancer Center |
Study Documents (Full-Text)
Documents provided by Novadaq Technologies ULC, now a part of Stryker:
Documents provided by Novadaq Technologies ULC, now a part of Stryker:
Study Protocol [PDF] August 25, 2017
Statistical Analysis Plan [PDF] June 23, 2017
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novadaq Technologies ULC, now a part of Stryker |
| ClinicalTrials.gov Identifier: | NCT02209532 History of Changes |
| Other Study ID Numbers: |
PP LNM 01 |
| First Posted: | August 6, 2014 Key Record Dates |
| Results First Posted: | March 25, 2019 |
| Last Update Posted: | March 25, 2019 |
| Last Verified: | March 2019 |
Keywords provided by Novadaq Technologies ULC, now a part of Stryker:
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Lymph node mapping Endometrial cancer Uterine cancer Cervical cancer |
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms Endometrial Neoplasms Uterine Neoplasms Neoplasms Genital Neoplasms, Female |
Urogenital Neoplasms Neoplasms by Site Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female |