N/A
Completed N=50
Efficacy of Gamma Camera Used Intraoperatively for ID of Sentinel Lymph Nodes w/ Lymphoscintigraphy
Source: ClinicalTrials.gov NCT01314963 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcomePrimary: Relative Node Detection Sensitivity — 88.5; 94.2 Percentage (%) of SLNs detected
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relative Node Detection Sensitivity |
88.5; 94.2 | — |
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
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. Informational only — not medical advice.