Efficacy of Gamma Camera Used Intraoperatively for ID of Sentinel Lymph Nodes w/ Lymphoscintigraphy
Recruitment status was Active, not recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | March 11, 2011 | ||||||||
| Last Updated Date | March 11, 2011 | ||||||||
| Start Date ICMJE | June 2008 | ||||||||
| Estimated Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Efficacy of Gamma Camera Used Intraoperatively for ID of Sentinel Lymph Nodes w/ Lymphoscintigraphy | ||||||||
| Official Title ICMJE | Efficacy of a Novel, High-Sensitivity, Portable, Hand-Held Gamma Camera Used Intraoperatively for Identification of Sentinel Lymph Nodes With Lymphoscintigraphy | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Multiple Myeloma | ||||||||
| Intervention ICMJE | Device: Handheld Gamma Camera
Hand-held, portable, intraoperative gamma camera |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||
| Estimated Completion Date | April 2011 | ||||||||
| Estimated Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | 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. |
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01314963 | ||||||||
| Other Study ID Numbers ICMJE | SU-03092011-7560, MEL0004 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Mike Yao MD, Stanford University School of Medicine | ||||||||
| Study Sponsor ICMJE | Stanford University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Stanford University | ||||||||
| Verification Date | March 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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