Clinical trial NCT00463892: High-resolution Magnetic Resonance Imaging (MRI) Scans to Look for Spread of Melanoma to Nearby Lymph Nodes
Official title: A Phase II Study of High-resolution Contrast-enhanced MRI of Regional Lymph Nodes in Patients With Clinically Localized Invasive Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma
Keywords: melanoma
lymph nodes
magnetic resonance imaging
screening
detection
Lead sponsor: Redwood Regional Medical Group
Sponsor class: OTHER
First posted: 2007-04-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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 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)

Primary outcomes:
measure: Assessment of the sensitivity and specificity of high-resolution MRI scans of regional lymph nodes compared to results from regional lymph node biopsy.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sebastopol
country: United States
facility: Redwood Regional Medical Group
state: California
Study officials:
affiliation: Redwood Regional Medical Group
name: Peter Brett, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Redwood Regional Medical Group
name: David Feinberg, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: