Efficacy of Gamma Camera Used Intraoperatively for ID of Sentinel Lymph Nodes w/ Lymphoscintigraphy

Not Recruiting

Trial ID: NCT01314963

Age - 18 Years-N/A Condition - Multiple Myeloma Gender - All Accepting Healthy Volunteers - No

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)

Craig Levin

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

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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

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