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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01314963
• Other study ID #: IRB-06037
• Secondary ID: SU-03092011-7560
• Status: Completed
• Phase: N/A
• Start date: June 2008
• Est. completion date: July 26, 2012

Study information

• Verified date: March 2018
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 26, 2012
• Est. primary completion date: July 26, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Multiple Myeloma

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Whitaker Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative Node Detection Sensitivity	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.	1 day