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Evaluation Of Mobile Gamma Camera Imaging For Sentinel Node Biopsy In Melanoma (Mel54)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01531608
Recruitment Status : Completed
First Posted : February 13, 2012
Last Update Posted : April 22, 2015
Information provided by (Responsible Party):
Craig L Slingluff, Jr, University of Virginia

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.

Condition or disease

Detailed Description:

Patients who are scheduled to undergo sentinel node biopsy as part of recommended clinical care will be offered participation in this study.

Patients enrolled in this study will receive standard lymphoscintigraphy in nuclear medicine; however, these images will not be reviewed by the investigator until the preoperative mobile gamma camera(MGC)images have been obtained. Upon completion of the preoperative MGC imaging, the investigator will define the location of SLNs and the plan for the surgical approach. The investigator will then review the FGC images and assess the agreement of these two imaging methodologies. The hand-held gamma probe will be used to further evaluate the patient at this time and a final determination of true hot spots will be made based on the information and the clinical judgment of the operating surgeon. The final surgical plan will be decided. The primary data to be obtained from this cohort will be confirmation of the use of MGC imaging as a screening device to identify all nodal basins containing SLNs.

An additional goal of this study will be to identify techniques that may improve the use of the MGC and opportunities for optimizing the MGC device and imaging system. To the extent possible, improvements to the system will be made incrementally. A goal is to have a more optimized system before the next trial.

In addition to the preoperative imaging data discussed above, the participants will be reevaluated intraoperatively with a MGC and the hand-held probe at the following time points:

  1. after removal of each sentinel node
  2. after completion of the sentinel node biopsy procedure In each of these assessments, the following will be recorded: the number and location of sentinel nodes, the correspondence with preoperative hot spots determined by the clinical gamma detection devices (fixed camera, MGC and hand-held probe), the time required for imaging, and technical features of use, advantages, and limitations of the MGC imaging system. The individual sentinel nodes will be imaged ex vivo and counted with the hand-held probe.

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation Of Mobile Gamma Camera Imaging For Sentinel Node Biopsy In Melanoma Independent Of Fixed Gamma Camera Imaging
Study Start Date : March 2011
Actual Primary Completion Date : February 2012

Primary Outcome Measures :
  1. Identification of "misses" in which the operative approach was altered using data from the FGC. [ Time Frame: intraoperative ]
    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.

  2. Quantification of the time required to use the MGC imaging system for initial lymphoscintigraphy imaging [ Time Frame: In minutes and seconds ]
  3. The rate of agreement of hot spot detection between the FGC and MGC imaging systems. [ Time Frame: intraoperative ]
    Recorded as a percentage of total hotspots detected between both modalities

  4. Success rate of MGC imaging and the gamma probe in identifying SLNs independent of investigator review of FGC imaging findings [ Time Frame: Intraoperative ]
    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.

  5. 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 [ Time Frame: Intraoperative ]
    Descriptive statistics will be used to describe individual cases where the MGC provided information that would alter surgical decision making.

Secondary Outcome Measures :
  1. Logistical issues of use of MGC imaging as currently configured. [ Time Frame: Intraoperative and perioperative ]
    This is recorded on Likert score based surveys administered to the study surgeon regarding the logistic ease of the process of using the MGC devices.

  2. 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). [ Time Frame: Intraoperative and perioperative ]
  3. Investigator identification of clinical scenarios where the hand-held gamma probe provided additional benefit to the MGC for pre-operative evaluation of hot spots. [ Time Frame: Intraoperative ]
    Descriptive statistics will again be used to define specific cases where this occurred.

  4. Ergonomic optimization of our method for intraoperative gamma imaging as measured by operative time and surgeon satisfaction. [ Time Frame: Preoperative and intraoperative ]
    This will include specific changes to the MGC systems implemented to increase ease of use and sensitivity of the system.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01531608

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United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
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Principal Investigator: Craig L Slingluff, MD University of Virginia
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Responsible Party: Craig L Slingluff, Jr, Professor, Department of Surgery, University of Virginia Identifier: NCT01531608    
Other Study ID Numbers: 15343
First Posted: February 13, 2012    Key Record Dates
Last Update Posted: April 22, 2015
Last Verified: April 2015
Keywords provided by Craig L Slingluff, Jr, University of Virginia:
sentinel node
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas