SPY-X: A Study to Assess the Feasibility of Using SPY Alone for Sentinel Node Localization for Melanoma or Breast Cancer

NCT03294330 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 7046
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 3

Brief Summary

The objective of this study is to determine if fluorescence lymphangiography can be used alone to localize sentinel nodes in patients with melanoma or breast cancer. The hypothesis is that sentinel nodes can be identified using only indocyanine green (ICG) and fluorescence lymphangiography, without the need for technetium99 and a gamma probe.

Conditions

Sentinel Lymph Node; Melanoma (Skin); Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants Where the First, Second and Third Sentinel Nodes Localized With the Use of Fluorescence Imaging Alone

  The number of participants who had their first, second and third sentinel nodes correctly identified with ICG and fluorescence imaging alone, without the use of technetium99 and gamma probe. The number of sentinel nodes in any participant is determined by the patient's anatomy.

  Intraoperative, up to 1 hour

Secondary Outcomes (1)

• Adverse Events

  Four weeks

Study Arms (1)

Patients with Melanoma or Breast Cancer

EXPERIMENTAL

The SPY machine used in conjunction with the IC-green kit will be used exclusively to identify sentinel nodes in patients diagnosed with Melanoma or Breast Cancer who are undergoing sentinel lymph node biopsy.

Drug: IC-Green KIT

Interventions

IC-Green KIT DRUG

fluorescence lymphangiography with the use of IC-Green

Patients with Melanoma or Breast Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with melanoma or breast cancer who meet criteria for and consent to sentinel node biopsy.The melanoma should be located on the upper extremity between and including the wrist and shoulder, or the lower extremity between and including the ankle and groin.

You may not qualify if:

• Melanoma located on the trunk, head or neck. Patients with an allergy to indocyanine green or sodium iodide. Pregnant and nursing women. Patients who have had a prior sentinel node biopsy in the same nodal basin.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• Vassar Brothers Medical Center: collaborator
• Emory University: collaborator

Study Sites (3)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Vassar Brothers Medical Center

Poughkeepsie, New York, 12601, United States

Location

PennState Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Melanoma; Breast Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Breast Diseases

Results Point of Contact

• Title: Colette Pameijer
• Organization: Penn State College of Medicine

cpameijer@pennstatehealth.psu.edu

717-531-5272

Study Officials

• Colette Pameijer, MD

  Penn State Hershey Medical Center and College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: September 27, 2017
• Study Start: October 11, 2017
• Primary Completion: September 17, 2021
• Study Completion: November 2, 2021
• Last Updated: January 12, 2023
• Results First Posted: January 12, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)