Trial Search Results
Efficacy of Gamma Camera Used Intraoperatively for ID of Sentinel Lymph Nodes w/ 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.
Stanford is currently not accepting patients for this trial.
- Device: Handheld Gamma Camera
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
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
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
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.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study