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

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ClinicalTrials.gov Identifier: NCT01314963
Recruitment Status : Completed
First Posted : March 15, 2011
Results First Posted : April 30, 2018
Last Update Posted : April 30, 2018
Sponsor:
Collaborator:
Whitaker Foundation
Information provided by (Responsible Party):
John B. Sunwoo, Stanford University

Brief Summary:
This study evaluates the ability of a prototype intraoperative handheld gamma camera (pIHGC) to image (detect) sentinel lymph nodes (SLNs) in melanoma and breast cancer during surgical excision, as compared to standard of care intraoperative gamma probes (GP). The unit of study in this trial was SNLs rather individual participants. Each device was assessed for relative node detection sensitivity (S) of those SLNs.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Breast Cancer Device: Prototype intraoperative handheld gamma camera (pIHGC) Device: Lymphoscintigraphy with intraoperative gamma probes (GP) Radiation: radioactive Tc99M Not Applicable

Detailed Description:

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 (ie, the "sentinel lymph node, SLN") to determine if cancer has spread. The study objective was to evaluate the potential benefit of a new, camera-based technology (prototype device) which allows actual images to be obtained intra-operatively in the identification of sentinel nodes.

Each device was assessed for relative node detection sensitivity (S), defined as the proportion of sentinel lymph nodes (SLNs) that were identified with each instrument, with the proportion determined as the number of true positives (TP) divided by the total evaluated (N).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: The unit of study in this trial was sentinel lymph nodes (SLNs) rather individual participants. with the comparison conducted by evaluation of each SLN with the prototype intraoperative handheld gamma camera (pIHGC) and standard of care intraoperative gamma probes (GP).
Masking: None (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
Actual Study Start Date : June 2008
Actual Primary Completion Date : July 26, 2012
Actual Study Completion Date : July 26, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: Intraoperative handheld Gamma Camera (pIHGC)
The prototype intraoperative handheld gamma camera (pIHGC)
Device: Prototype intraoperative handheld gamma camera (pIHGC)
The prototype intraoperative handheld gamma camera (pIHGC) consists of a parallel-hole lead collimator coupled to a pixilated sodium iodide-thallium [NaI(Tl)] scintillation crystal array, itself coupled to a flat panel, multi-anode Hamamatsu H8500 position-sensitive photomultiplier tube. The collimator is 5x5 cm2 large in area and 1.5 cm thick, with 1.3 mm hexagonal holes and 0.2 mm septa. The 1.7 mm pitch crystal array is composed of 29x29 individual crystals, each 1.5x1.5x6 mm3 in size.

Radiation: radioactive Tc99M
Lymphoscintigraphy involves injection of 0.4 to 1.0 mCi of radioactive Tc99M sulfur colloid around at the tumor site.

Active Comparator: Gamma probes (GP)
Standard of care intraoperative gamma probes (GP) currently in use.
Device: Lymphoscintigraphy with intraoperative gamma probes (GP)
Lymphoscintigraphy with standard of care intraoperative gamma probes (GP)

Radiation: radioactive Tc99M
Lymphoscintigraphy involves injection of 0.4 to 1.0 mCi of radioactive Tc99M sulfur colloid around at the tumor site.




Primary Outcome Measures :
  1. Relative Node Detection Sensitivity [ Time Frame: 1 day ]
    Relative node detection sensitivity (S) was defined as the proportion of sentinel lymph nodes (SLNs) that were identified with each instrument, with the proportion determined as the number of true positives (TP) divided by the total evaluated (N). The outcome result is expressed as the percentage for each device with 95% confidence intervals.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

  • Malignancy for which sentinel node biopsy with lymphoscintigraphy are indicated as part of the standard of care for tumor staging
  • Age 18 or greater.
  • Healthy enough for surgery
  • Able to understand and willing to sign a written informed consent document.

EXCLUSION CRITERIA

  • No exclusion requirements due to co-morbid disease or intercurrent illness.
  • Documented allergy to colloid.
  • Lymphoscintigraphy presents excessive high risk, eg, a consideration if pregnant or lactating

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01314963


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Whitaker Foundation
Investigators
Principal Investigator: John B Sunwoo, MD Stanford University

Publications of Results:
Responsible Party: John B. Sunwoo, Assistant Professor of Otolaryngology - Head and Neck Surgery, Stanford University
ClinicalTrials.gov Identifier: NCT01314963     History of Changes
Other Study ID Numbers: IRB-06037
SU-03092011-7560 ( Other Identifier: Stanford University )
MEL0004 ( Other Identifier: OnCore )
First Posted: March 15, 2011    Key Record Dates
Results First Posted: April 30, 2018
Last Update Posted: April 30, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

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