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

NCT03294330 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2023-01-12

Study results available
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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

Interventions

DRUG

IC-Green KIT

fluorescence lymphangiography with the use of IC-Green

Sponsors & Collaborators

  • Vassar Brothers Medical Center

    collaborator OTHER

  • Emory University

    collaborator OTHER

  • Milton S. Hershey Medical Center

    lead OTHER

Principal Investigators

  • Colette Pameijer, MD · Penn State Hershey Medical Center and College of Medicine

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-11
Primary Completion
2021-09-17
Completion
2021-11-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03294330 on ClinicalTrials.gov