Efficacy of Gamma Camera Used Intraoperatively for ID of Sentinel Lymph Nodes w/ Lymphoscintigraphy
This trial is active, not recruiting.
|Treatment||handheld gamma camera|
|Start date||June 2008|
|End date||April 2011|
|Trial size||100 participants|
|Trial identifier||NCT01314963, MEL0004, SU-03092011-7560|
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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
Ability of the gamma camera to identify the sentinel lymph nodes identified by the gamma probe.
time frame: 2 years
Male or female participants at least 18 years old.
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.
|Official title||Efficacy of a Novel, High-Sensitivity, Portable, Hand-Held Gamma Camera Used Intraoperatively for Identification of Sentinel Lymph Nodes With Lymphoscintigraphy|
|Principal investigator||Dr Craig Levin|
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