Breast Cancer Clinical Trial
— SPYXOfficial title:
SPY-X: A Study to Assess the Feasibility of Using Real-time Fluorescence Lymphangiography Alone for Sentinel Node Localization in Patients With Melanoma or Breast Cancer
Verified date | December 2022 |
Source | Milton S. Hershey Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 35 |
Est. completion date | November 2, 2021 |
Est. primary completion date | September 17, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Emory University Hospital | Atlanta | Georgia |
United States | PennState Health Milton S. Hershey Medical Center | Hershey | Pennsylvania |
United States | Vassar Brothers Medical Center | Poughkeepsie | New York |
Lead Sponsor | Collaborator |
---|---|
Milton S. Hershey Medical Center | Emory University, Vassar Brothers Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Adverse Events | Any adverse events related to ICG or sentinel node biopsy. | Four weeks |
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