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A Phase II Study of High-resolution Contrast-enhanced MRI of Regional Lymph Nodes in Patients With Clinically Localized Invasive Melanoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Melanoma

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Trial Information

A Phase II Study of High-resolution Contrast-enhanced MRI of Regional Lymph Nodes in Patients With Clinically Localized Invasive Melanoma


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.


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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Assessment of the sensitivity and specificity of high-resolution MRI scans of regional lymph nodes compared to results from regional lymph node biopsy.

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Peter Brett, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Redwood Regional Medical Group

Authority:

United States: Institutional Review Board

Study ID:

RRMG #07-001

NCT ID:

NCT00463892

Start Date:

June 2007

Completion Date:

June 2013

Related Keywords:

  • Melanoma
  • melanoma
  • lymph nodes
  • magnetic resonance imaging
  • screening
  • detection
  • Melanoma

Name

Location

Redwood Regional Medical GroupSanta Rosa, California  95403