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

NCT ID: NCT01314963

Last Updated: 2018-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2012-07-26

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.

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).

Conditions

Multiple Myeloma; Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Intraoperative handheld Gamma Camera (pIHGC)

The prototype intraoperative handheld gamma camera (pIHGC)

Group Type: EXPERIMENTAL

Prototype intraoperative handheld gamma camera (pIHGC)

Intervention Type: DEVICE

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.

radioactive Tc99M

Intervention Type: RADIATION

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

Gamma probes (GP)

Standard of care intraoperative gamma probes (GP) currently in use.

Group Type: ACTIVE_COMPARATOR

Lymphoscintigraphy with intraoperative gamma probes (GP)

Intervention Type: DEVICE

Lymphoscintigraphy with standard of care intraoperative gamma probes (GP)

radioactive Tc99M

Intervention Type: RADIATION

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

Interventions

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.

Intervention Type: DEVICE

Lymphoscintigraphy with intraoperative gamma probes (GP)

Lymphoscintigraphy with standard of care intraoperative gamma probes (GP)

Intervention Type: DEVICE

radioactive Tc99M

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

Intervention Type: RADIATION

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Whitaker Foundation

UNKNOWN

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

John B. Sunwoo

Assistant Professor of Otolaryngology - Head and Neck Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John B Sunwoo, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 24239343 (View on PubMed)

Other Identifiers

SU-03092011-7560

Identifier Type: OTHER

Identifier Source: secondary_id

MEL0004

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-06037

Identifier Type: -

Identifier Source: org_study_id