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

Completed · Not applicable

Conditions studied: Multiple Myeloma, Breast Cancer

In brief

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.

Key facts

Study ID

NCT01314963

Run by

Stanford University

People needed

50

Starts

2008-06-01

Expected to finish

2012-07-26

Last updated by the study team

2018-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Stanford University School of Medicine — Stanford, California, United States

Full record on ClinicalTrials.gov

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