Clinical trial · Interventional
Efficacy of Gamma Camera Used Intraoperatively for ID of Sentinel Lymph Nodes w/ Lymphoscintigraphy
Efficacy of a Novel, High-Sensitivity, Portable, Hand-Held Gamma Camera Used Intraoperatively for Identification of Sentinel Lymph Nodes With Lymphoscintigraphy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lymphoscintigraphy with intraoperative gamma probes (GP) | Device | — | UNRESOLVED |
| Prototype intraoperative handheld gamma camera (pIHGC) | Device | — | UNRESOLVED |
| radioactive Tc99M | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intraoperative handheld Gamma Camera (pIHGC)
- description
- The prototype intraoperative handheld gamma camera (pIHGC)
- interventionNames
- Device: Prototype intraoperative handheld gamma camera (pIHGC)
- Radiation: radioactive Tc99M
- type
- ACTIVE_COMPARATOR
- label
- Gamma probes (GP)
- description
- Standard of care intraoperative gamma probes (GP) currently in use.
- interventionNames
- Device: Lymphoscintigraphy with intraoperative gamma probes (GP)
- Radiation: radioactive Tc99M
Primary outcomes (1)
- measure
- Relative Node Detection Sensitivity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTOlcott 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. PMID 24239343