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
  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

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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)
Intervention Details:
    Device: Handheld Gamma Camera
    Hand-held, portable, intraoperative gamma camera
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01314963

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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 April 16, 2014