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MelanomaMel54NCT01531608

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

An observational study of Melanoma, run by University of Virginia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
How many people
20 participants
Where
1 siteUnited States
Study dates
Mar 2011to Feb 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

Other trials in United States

About this study

Official title: Evaluation Of Mobile Gamma Camera Imaging For Sentinel Node Biopsy In Melanoma Independent Of Fixed Gamma Camera Imaging

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.

Read the 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.
Conditions
Melanoma
Keywords
melanoma, imaging, sentinel node, biopsy
Medical subject headings
Melanoma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: intraoperative

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

    Measured: In minutes and seconds

  3. 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

    Measured: intraoperative

  4. 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.

    Measured: Intraoperative

  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

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

    Measured: Intraoperative

Secondary outcomes (4)

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

    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.

    Measured: Intraoperative and perioperative

  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).

    Measured: 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.

    Descriptive statistics will again be used to define specific cases where this occurred.

    Measured: Intraoperative

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

    This will include specific changes to the MGC systems implemented to increase ease of use and sensitivity of the system.

    Measured: Preoperative and intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2012 (estimated)
  2. Study startMar 2011
  3. Primary completionFeb 2012
  4. Study completionFeb 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01531608
Sponsor's protocol ID
15343
Acronym
Mel54
Status last verified
Dec 2023
First submitted
30 Jan 2012
Last updated
15 Dec 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 36682343

Questions about this trial

What is this clinical trial studying?

An observational study of Melanoma, run by University of Virginia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Identification of "misses" in which the operative approach was altered using data from the FGC. (time frame: intraoperative). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01531608, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.

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