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Efficacy of a Novel, High-Sensitivity, Portable, Hand-Held Gamma Camera Used Intraoperatively for Identification of Sentinel Lymph Nodes With Lymphoscintigraphy


N/A
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

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Trial Information

Efficacy of a Novel, High-Sensitivity, Portable, Hand-Held Gamma Camera Used Intraoperatively for Identification of Sentinel Lymph Nodes With Lymphoscintigraphy


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Ability of the gamma camera to identify the sentinel lymph nodes identified by the gamma probe.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Dr Craig Levin

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

SU-03092011-7560

NCT ID:

NCT01314963

Start Date:

June 2008

Completion Date:

April 2011

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Stanford University School of MedicineStanford, California  94305-5317