Mode
Home
Research
Clinical Trials Drug Pipeline Weekly Digests
Reference
Conditions Medications
Community
Questions
Text Size
Log in / Sign up
N/A N=50 Diagnostic

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

Multiple Myeloma · Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT01314963 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcome: Primary: Relative Node Detection Sensitivity — 88.5; 94.2 Percentage (%) of SLNs detected

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Prototype intraoperative handheld gamma camera (pIHGC) (Device); Lymphoscintigraphy with intraoperative gamma probes (GP) (Device); radioactive Tc99M (Radiation)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Stanford University
Primary completion
Jul 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Relative Node Detection Sensitivity		 88.5; 94.2 —

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01314963). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search