Clinical trial · Observational
Evaluation Of Mobile Gamma Camera Imaging For Sentinel Node Biopsy In Melanoma
Evaluation Of Mobile Gamma Camera Imaging For Sentinel Node Biopsy In Melanoma Independent Of Fixed Gamma Camera Imaging
NCT01531608CI-TRIAL-00072302Mel54completedClinicalTrials.gov clinicaltrialsProvenance
- 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 is a single-institution study seeking to evaluate if mobile gamma camera imaging can be used independent of standard fixed gamma camera imaging in patients undergoing sentinel node biopsy for melanoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (5)
- measure
- Identification of "misses" in which the operative approach was altered using data from the FGC.
- timeFrame
- intraoperative
- description
- A "miss" is any alteration in surgical plan after review of FGC data to prevent decr sensitivity for the sentinel node (SN), or incr morbidity. Any change to surgical plan that results in a change of anatomic or incision location, or addition of lymph node (LN) location will qualify as a miss. Removal of "hot" LN based on MGC data that would not have been removed based on FGC imaging will not be counted as a "miss," incl non-localization of a SN by FGC imaging, provided they are within 10% of the counts of the "hottest" node.
- measure
- Quantification of the time required to use the MGC imaging system for initial lymphoscintigraphy imaging
- timeFrame
- In minutes and seconds
- measure
- The rate of agreement of hot spot detection between the FGC and MGC imaging systems.
- timeFrame
- intraoperative
- description
- Recorded as a percentage of total hotspots detected between both modalities
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with a diagnosis of melanoma for whom a sentinel node biopsy is planned as part of standard surgical management of the melanoma. Patients may have more than one primary lesion. * Patients with other malignancies may be included in this study, but the primary focus of this study is on melanoma, and data analysis of the melanoma patients will be independent of patients for whom sentinel node biopsy is done for other malignancies. It may also include patients for whom the diagnosis of melanoma is not certain but sentinel node biopsy is planned as part of the standard management (e.g.: severely atypical melanocytic neoplasms of uncertain malignant potential). * All patients must have the ability and willingness to give informed consent. * Age 18 years or older at the time of study entry. (Younger patients are excluded for simplicity since this avoids the requirement for separate consent documents, this is just a pilot study, and patients under age 18 are uncommon enough that they would not be likely to be enrolled in this small pilot study) Exclusion Criteria: * Participants in whom there is a medical contraindication or potential problem in complying with the requirements of the protocol in the opinion of the investigator * Patients receiving there technetium injection more than 12 hours prior to their scheduled surgery
References
Publications (1)
- DERIVEDJudge JM, Popovic K, Petroni GR, Kross B, McKisson J, McKisson J, Weisenberger AG, Stolin A, Majewski S, Rehm P, Slingluff CL, Williams MB, Dengel LT. Evaluation of Preoperative and Intraoperative Mobile Gamma Camera Imaging in Sentinel Lymph Node Biopsy for Melanoma Independent of Preoperative Lymphoscintigraphy. J Surg Res. 2023 May;285:176-186. doi: 10.1016/j.jss.2022.12.013. Epub 2023 Jan 20. PMID 36682343