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Efficacy of Gamma Camera Used Intraoperatively for ID of Sentinel Lymph Nodes w/ Lymphoscintigraphy
Not Recruiting
Trial ID: NCT01314963
Purpose
This study evaluates the ability of a prototype intraoperative handheld gamma camera (pIHGC) to image (detect) sentinel lymph nodes (SLNs) in melanoma and breast cancer during surgical excision, as compared to standard of care intraoperative gamma probes (GP). The unit of study in this trial was SNLs rather individual participants. Each device was assessed for relative node detection sensitivity (S) of those SLNs.
Official Title
Efficacy of a Novel, High-Sensitivity, Portable, Hand-Held Gamma Camera Used Intraoperatively for Identification of Sentinel Lymph Nodes With Lymphoscintigraphy
Stanford Investigator(s)
Eligibility
INCLUSION CRITERIA
* Malignancy for which sentinel node biopsy with lymphoscintigraphy are indicated as part of the standard of care for tumor staging
* Age 18 or greater.
* Healthy enough for surgery
* Able to understand and willing to sign a written informed consent document.
EXCLUSION CRITERIA
* No exclusion requirements due to co-morbid disease or intercurrent illness.
* Documented allergy to colloid.
* Lymphoscintigraphy presents excessive high risk, eg, a consideration if pregnant or lactating
Intervention(s):
device: Prototype intraoperative handheld gamma camera (pIHGC)
device: Lymphoscintigraphy with intraoperative gamma probes (GP)
radiation: radioactive Tc99M
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Mike YaO
3125435207