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High-resolution Magnetic Resonance Imaging (MRI) Scans to Look for Spread of Melanoma to Nearby Lymph Nodes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00463892
First Posted: April 20, 2007
Last Update Posted: November 11, 2014
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.
Information provided by (Responsible Party):
Peter Brett, M.D., Redwood Regional Medical Group
  Purpose
The study is designed to see if a high-resolution MRI scan of lymph node areas near where a melanoma has been removed from the skin can pick up the spread of melanoma to those lymph nodes with a high degree of accuracy.

Condition Intervention Phase
Melanoma Procedure: High-resolution contrast-enhanced MRI scan Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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

Resource links provided by NLM:


Further study details as provided by Peter Brett, M.D., Redwood Regional Medical Group:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: June 2007
Study Completion Date: June 2013
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: High-resolution contrast-enhanced MRI scan
    High-resolution contrast-enhanced MRI scan of regional lymph nodes every 6 months on study
Detailed Description:

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.

  Eligibility

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

Inclusion Criteria:

  • history of invasive cutaneous melanoma stages 1-3 within 2 years of treatment of the melanoma by primary excision
  • eligible whether or not a sentinel lymph node biopsy or regional lymph node dissection has been performed
  • adequate renal function (creatinine 2 or less)
  • life expectancy 2 years of more

Exclusion Criteria:

  • history of severe claustrophobia precluding MRI scans
  • known hypersensitivity or other contraindication to gadolinium contrast
  • known presence of metastatic melanoma at sites beyond regional lymph nodes (stage 4)
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00463892


Locations
United States, California
Redwood Regional Medical Group
Sebastopol, California, United States, 95472
Sponsors and Collaborators
Redwood Regional Medical Group
Investigators
Principal Investigator: Peter Brett, M.D. Redwood Regional Medical Group
Principal Investigator: David Feinberg, M.D., Ph.D. Redwood Regional Medical Group
  More Information

Additional Information:
Responsible Party: Peter Brett, M.D., Physician, Redwood Regional Medical Group
ClinicalTrials.gov Identifier: NCT00463892     History of Changes
Other Study ID Numbers: RRMG #07-001
First Submitted: April 19, 2007
First Posted: April 20, 2007
Last Update Posted: November 11, 2014
Last Verified: November 2014

Keywords provided by Peter Brett, M.D., Redwood Regional Medical Group:
melanoma
lymph nodes
magnetic resonance imaging
screening
detection

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas