Evaluation Of Mobile Gamma Camera Imaging For Sentinel Node Biopsy In Melanoma

NCT01531608 | Completed DMC

• 1 other identifier: 15343
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Melanoma

Keywords

melanoma; imaging; sentinel node; biopsy

Outcome Measures

Primary Outcomes (5)

• Identification of "misses" in which the operative approach was altered using data from the FGC.

  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.

  intraoperative

• Quantification of the time required to use the MGC imaging system for initial lymphoscintigraphy imaging

  In minutes and seconds

• The rate of agreement of hot spot detection between the FGC and MGC imaging systems.

  Recorded as a percentage of total hotspots detected between both modalities

  intraoperative

• Success rate of MGC imaging and the gamma probe in identifying SLNs independent of investigator review of FGC imaging findings

  This is defined as the percentage of cases where the sentinel node was detected by the MGC and gamma probe surveys correctly prior to un-blinding to FGC images.

  Intraoperative

• The number of cases where the MGC identifies a false negative, a false positive, clarifies ambiguous FGC imaging or provides other specific clinical advantages for completion of SLNBx

  Descriptive statistics will be used to describe individual cases where the MGC provided information that would alter surgical decision making.

  Intraoperative

Secondary Outcomes (4)

• Logistical issues of use of MGC imaging as currently configured.

  Intraoperative and perioperative

• Time required for standard FGC imaging and time required for MGC imaging in the preoperative suite (time data from the Department of Radiology will be used to calculate the average imaging time associated with FGC imaging).

  Intraoperative and perioperative

• Investigator identification of clinical scenarios where the hand-held gamma probe provided additional benefit to the MGC for pre-operative evaluation of hot spots.

  Intraoperative

• Ergonomic optimization of our method for intraoperative gamma imaging as measured by operative time and surgeon satisfaction.

  Preoperative and intraoperative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with melanoma scheduled to undergo sentinel node biopsy as part of recommended clinical care, age 18 years or older.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

• Judge 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 DERIVED

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Craig L Slingluff, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Surgery

Study Record Dates

• First Submitted: January 30, 2012
• First Posted: February 13, 2012
• Study Start: March 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: December 15, 2023

Record last verified: 2023-12

Locations

US (1)