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Efficacy of Gamma Camera Used Intraoperatively for ID of Sentinel Lymph Nodes w/ Lymphoscintigraphy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Stanford University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01314963
First received: March 11, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted

March 11, 2011
March 11, 2011
June 2008
April 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Efficacy of Gamma Camera Used Intraoperatively for ID of Sentinel Lymph Nodes w/ Lymphoscintigraphy
Efficacy of a Novel, High-Sensitivity, Portable, Hand-Held Gamma Camera Used Intraoperatively for Identification of Sentinel Lymph Nodes With 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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Multiple Myeloma
Device: Handheld Gamma Camera
Hand-held, portable, intraoperative gamma camera
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
April 2011
April 2011   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01314963
SU-03092011-7560, MEL0004
Yes
Mike Yao MD, Stanford University School of Medicine
Stanford University
Not Provided
Principal Investigator: Dr Craig Levin Stanford University
Principal Investigator: Mike Yao MD Stanford University
Stanford University
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP