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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01314963
Recruitment Status : Unknown
Verified March 2011 by Stanford University.
Recruitment status was:  Active, not recruiting
First Posted : March 15, 2011
Last Update Posted : March 15, 2011
Information provided by:
Stanford University

March 11, 2011
March 15, 2011
March 15, 2011
June 2008
April 2011   (Final data collection date for primary outcome measure)
Ability of the gamma camera to identify the sentinel lymph nodes identified by the gamma probe. [ Time Frame: 2 years ]
Same as current
No Changes Posted
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Efficacy of Gamma Camera Used Intraoperatively for ID of Sentinel Lymph Nodes w/ Lymphoscintigraphy
Efficacy of a Novel, High-Sensitivity, Portable, Hand-Held Gamma Camera Used Intraoperatively for Identification of Sentinel Lymph Nodes With Lymphoscintigraphy
Lymphoscintigraphy is an accepted and commonly performed procedure used for staging of certain cancers, especially melanoma and breast cancer. It involves injecting a small amount of radioactivity under the skin in order to identify lymph nodes which should be biopsied (i.e., the "sentinel node") to determine if cancer has spread. Our objective is to evaluate the potential benefit of a new, camera-based technology which allows actual images to be obtained intraoperatively in the identification of sentinel nodes.
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Not Applicable
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Multiple Myeloma
Device: Handheld Gamma Camera
Hand-held, portable, intraoperative gamma camera
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
April 2011
April 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:3.1.1 Melanoma of the head and neck for which lymphoscintigraphy and sentinel lymph node biopsy are recommended as a standard of care

3.1.2 Prior therapy has no impact on eligibility as long as sentinel lymph node biopsy is indicated

3.1.4 Adults age 18 or greater.

3.1.5 No life expectancy restrictions.

3.1.6 The patients must be healthy enough for surgery

3.1.8 Patients must be able to understand and the willing to sign a written informed consent document.

Exclusion Criteria:3.2.1 No therapy restrictions.

3.2.2 No restrictions on use of other Investigational Agents.

3.2.3 No exclusion requirements due to co-morbid disease or incurrent illness.

3.2.4 Patients will be excluded if they have a documented allergy to colloid.

3.2.5 There are no known exclusion criteria relating to concomitant medications or substances that have the potential to affect the activity or pharmacokinetics of the study agent.

3.2.6 No other agent-specific exclusion criteria.

3.2.7 Pregnant and nursing patients will be excluded if lymphoscintigraphy is felt to be too high risk.

3.2.8 Cancer survivors and those who are HIV-positive will not be excluded from the study.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
MEL0004 ( Other Identifier: Stanford University )
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Mike Yao MD, Stanford University School of Medicine
Stanford University
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Principal Investigator: Dr Craig Levin Stanford University
Principal Investigator: Mike Yao MD Stanford University
Stanford University
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP