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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Redwood Regional Medical Group.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Peter Brett, M.D., Redwood Regional Medical Group
ClinicalTrials.gov Identifier:
NCT00463892
First received: April 19, 2007
Last updated: July 30, 2012
Last verified: July 2012
  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
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

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: June 2007
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

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
Study First Received: April 19, 2007
Last Updated: July 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on August 27, 2014