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)

Novadaq Technologies

Status: Completed

Conditions: Endometrial Cancer; Uterine Cancer; Cervical Cancer

Treatments: Device: PINPOINT

Study type: Interventional

Funder types: Industry

Identifiers

NCT02209532

PP LNM 01

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Blue - PINPOINT

Active Comparator group

Description:

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.

Treatment:

Device: PINPOINT

PINPOINT - Blue

Active Comparator group

Description:

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.

Treatment:

Device: PINPOINT