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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Device: Handheld Gamma Camera Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Efficacy of a Novel, High-Sensitivity, Portable, Hand-Held Gamma Camera Used Intraoperatively for Identification of Sentinel Lymph Nodes With Lymphoscintigraphy
Study Start Date : June 2008
Estimated Primary Completion Date : April 2011
Estimated Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Device: Handheld Gamma Camera
    Hand-held, portable, intraoperative gamma camera

Primary Outcome Measures :
  1. Ability of the gamma camera to identify the sentinel lymph nodes identified by the gamma probe. [ Time Frame: 2 years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01314963

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Principal Investigator: Dr Craig Levin Stanford University
Principal Investigator: Mike Yao MD Stanford University

Responsible Party: Mike Yao MD, Stanford University School of Medicine Identifier: NCT01314963     History of Changes
Other Study ID Numbers: SU-03092011-7560
MEL0004 ( Other Identifier: Stanford University )
First Posted: March 15, 2011    Key Record Dates
Last Update Posted: March 15, 2011
Last Verified: March 2011

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases