High-resolution Magnetic Resonance Imaging (MRI) Scans to Look for Spread of Melanoma to Nearby Lymph Nodes
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A Phase II Study of High-resolution Contrast-enhanced MRI of Regional Lymph Nodes in Patients With Clinically Localized Invasive Melanoma|
- Assessment of the sensitivity and specificity of high-resolution MRI scans of regional lymph nodes compared to results from regional lymph node biopsy. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2007|
|Study Completion Date:||June 2013|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Procedure: High-resolution contrast-enhanced MRI scan
When a melanoma of the skin is diagnosed, there is some chance it can spread to nearby lymph nodes, and from there to other parts of the body. Currently, patients with melanoma at low risk for spreading to lymph nodes do not get the lymph nodes assessed except by a physical exam. Those at high risk for spreading to lymph nodes get one or more lymph nodes removed surgically to check for melanoma spread. But physical exam alone will often miss small areas of melanoma in lymph nodes; removal of lymph nodes by surgery is painful and can cause complications. Neither assessment tool is optimal.
This study is designed to see if use of very high-resolution contrast-enhanced MRI scans of lymph node areas near the primary melanoma site in the skin can accurately detect small areas of melanoma spread to those lymph nodes. If this turns out to be the case, in the future, MRI scans could potentially be an alternative for assessing lymph nodes, compared to physical exams alone or surgical removal of the lymph nodes.
In this study, patients with low risk melanoma will receive very high-resolution MRI scans of nearby lymph nodes every 6 months for 5 years of follow-up. If the MRI looks abnormal, the lymph nodes will be biopsied, and results from the biopsy compared to the results from the MRI.
Patients with high risk melanoma will get a baseline MRI of the nearby lymph nodes, and then one or more lymph nodes will be removed (usually by sentinel lymph node biopsy) regardless of the MRI results. Again, results from the biopsy will be compared to the results from the MRI. MRI's will still be repeated every 6 months to assess whether lymph nodes not removed at surgery develop any changes.
We plan to enroll 200 patients on this study and by the end of the study will have a measure of the sensitivity and specificity of high-resolution MRI scans in the detection of melanoma involvement of regional lymph nodes.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00463892
|United States, California|
|Redwood Regional Medical Group|
|Sebastopol, California, United States, 95472|
|Principal Investigator:||Peter Brett, M.D.||Redwood Regional Medical Group|
|Principal Investigator:||David Feinberg, M.D., Ph.D.||Redwood Regional Medical Group|