NCT00463892

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 20, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2007

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

November 11, 2014

Status Verified

November 1, 2014

Enrollment Period

4.4 years

First QC Date

April 19, 2007

Last Update Submit

November 8, 2014

Conditions

Melanoma

Keywords

melanomalymph nodesmagnetic resonance imagingscreeningdetection

Outcome Measures

Primary Outcomes (1)

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

    5 years

Interventions

High-resolution contrast-enhanced MRI scanPROCEDURE

High-resolution contrast-enhanced MRI scan of regional lymph nodes every 6 months on study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Redwood Regional Medical Group

Sebastopol, California, 95472, United States

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Peter Brett, M.D.

    Redwood Regional Medical Group

    PRINCIPAL INVESTIGATOR

  • David Feinberg, M.D., Ph.D.

    Redwood Regional Medical Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

April 19, 2007

First Posted

April 20, 2007

Study Start

June 1, 2007

Primary Completion

November 1, 2011

Study Completion

June 1, 2013

Last Updated

November 11, 2014

Record last verified: 2014-11

Locations

US(1)