Efficacy of Gamma Camera Used Intraoperatively for ID of Sentinel Lymph Nodes w/ Lymphoscintigraphy
Recruitment status was Active, not recruiting
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Purpose
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 | Intervention |
|---|---|
|
Multiple Myeloma |
Device: Handheld Gamma Camera |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
- Ability of the gamma camera to identify the sentinel lymph nodes identified by the gamma probe. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | April 2011 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
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Device: Handheld Gamma Camera
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations| United States, California | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
| Principal Investigator: | Dr Craig Levin | Stanford University |
| Principal Investigator: | Mike Yao MD | Stanford University |
More Information
No publications provided
| Responsible Party: | Mike Yao MD, Stanford University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01314963 History of Changes |
| Other Study ID Numbers: | SU-03092011-7560, MEL0004 |
| Study First Received: | March 11, 2011 |
| Last Updated: | March 11, 2011 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013