Evaluation Of Mobile Gamma Camera Imaging For Sentinel Node Biopsy In Melanoma Independent Of Fixed Gamma Camera Imaging
18 Years
N/A
Both
Melanoma
Trial Information
Evaluation Of Mobile Gamma Camera Imaging For Sentinel Node Biopsy In Melanoma Independent Of Fixed Gamma Camera Imaging
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.
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Identification of "misses" in which the operative approach was altered using data from the FGC.
Outcome 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.
Principal Investigator
Craig L Slingluff, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Virginia
Authority:
United States: Institutional Review Board
Study ID:
15343
NCT ID:
NCT01531608
Start Date:
March 2011
Completion Date:
Related Keywords:
- Melanoma
- melanoma
- imaging
- sentinel node
- biopsy
- Melanoma
Name | Location |
|---|---|
| University of Virginia Health System | Charlottesville, Virginia 22903 |
