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Tilting of Radioactive Plaques After Initial Accurate Placement for Treatment of Uveal Melanoma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2008 by Barnes Retina Institute.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00459849
First Posted: April 13, 2007
Last Update Posted: May 9, 2008
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:
Barnes Retina Institute
  Purpose
Plaque radiotherapy is a common treatment for uveal melanoma. However, local failure has been reported in up to 20% of patients. We use intraoperative ultrasonography at plaque insertion and removal to evaluate plaque movement as a potential factor in local failure.

Condition Intervention
Uveal Melanoma Procedure: Intraoperative ultrasonography

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tilting of Radioactive Plaques After Initial Accurate Placement for Treatment of Uveal Melanoma

Resource links provided by NLM:


Further study details as provided by Barnes Retina Institute:

Primary Outcome Measures:
  • Plaque tilt using intraoperative ultrasonography [ Time Frame: End of study ]
  • Local melanoma failure [ Time Frame: End of study ]

Estimated Enrollment: 175
Study Start Date: July 2000
Estimated Study Completion Date: July 2007
Estimated Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Intraoperative ultrasonography
    Intraoperative ultrasonography will be used to determine plaque placement.
Detailed Description:
Episcleral plaque radiotherapy is a common treatment for uveal melanoma and results in local tumor control in most cases. However, local failure has been reported in a substantial proportion of patients. Since local failure greatly increases the risk of metastatic death, identifying and correcting the causes of local treatment failure are of paramount importance. Poor plaque localization is an important contributing factor to local failure. With the aid of intraoperative ultrasonography, most malpositioned plaques can be identified and readjusted at the time of plaque insertion. However, little is known about plaque movement during the 4-5 days of brachytherapy, which could also contribute to local failure. To address this question, we perform intraoperative B-scan ultrasonography at the time of iodine-125 radioactive plaque insertion and removal in uveal melanoma patients.
  Eligibility

Information from the National Library of Medicine

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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:

  • All patients with uveal melanoma treated with brachytherapy

Exclusion Criteria:

  • Ciliary melanoma
  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): NCT00459849


Locations
United States, Missouri
Washington University in St. Louis School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Barnes Retina Institute
Investigators
Principal Investigator: J W Harbour, MD Washington University School of Medicine
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Archavan Almony, M.D., Barnes Retina Institute
ClinicalTrials.gov Identifier: NCT00459849     History of Changes
Other Study ID Numbers: HRPO# 07-0092
First Submitted: April 11, 2007
First Posted: April 13, 2007
Last Update Posted: May 9, 2008
Last Verified: May 2008

Keywords provided by Barnes Retina Institute:
Melanoma
Brachytherapy
Ultrasonography

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