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

• 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: Stanford University
• Collaborator: Whitaker Foundation
• Information provided by (Responsible Party): John B. Sunwoo, Stanford University

Study Description

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 Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

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

More Information

Publications of Results:

Olcott P, Pratx G, Johnson D, Mittra E, Niederkohr R, Levin CS. Clinical evaluation of a novel intraoperative handheld gamma camera for sentinel lymph node biopsy. Phys Med. 2014 May;30(3):340-5. doi: 10.1016/j.ejmp.2013.10.005. Epub 2013 Nov 14.

• Responsible Party: John B. Sunwoo, Assistant Professor of Otolaryngology - Head and Neck Surgery, Stanford University
• ClinicalTrials.gov Identifier: NCT01314963
• Other Study ID Numbers: IRB-06037; SU-03092011-7560 ( Other Identifier: Stanford University ); MEL0004 ( Other Identifier: OnCore )
• First Posted: March 15, 2011
• 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
• 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