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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2008 by Barnes Retina Institute. Recruitment status was Active, not recruiting

First Received on April 11, 2007. Last Updated on May 6, 2008 History of Changes

Sponsor:	Barnes Retina Institute
Information provided by:	Barnes Retina Institute
ClinicalTrials.gov Identifier:	NCT00459849

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 Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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:

Genetics Home Reference related topics: retinoblastoma

MedlinePlus related topics: Melanoma Ultrasound

U.S. FDA Resources

Further study details as provided by Barnes Retina Institute:

Primary Outcome Measures:

Plaque tilt using intraoperative ultrasonography [ Time Frame: End of study ] [ Designated as safety issue: No ]
Local melanoma failure [ Time Frame: End of study ] [ Designated as safety issue: No ]

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:

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All patients with uveal melanoma treated with brachytherapy

Exclusion Criteria:

Ciliary melanoma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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:

Harbour JW. Clinical overview of uveal melanoma: introduction to tumors of the eye. In: Albert DM, Polans A, eds. Ocular Oncology. New York: Marcel Dekker; 2003:1-18.

Char DH, Quivey JM, Castro JR, Kroll S, Phillips T. Helium ions versus iodine 125 brachytherapy in the management of uveal melanoma. A prospective, randomized, dynamically balanced trial. Ophthalmology. 1993 Oct;100(10):1547-54.

Garretson BR, Robertson DM, Earle JD. Choroidal melanoma treatment with iodine 125 brachytherapy. Arch Ophthalmol. 1987 Oct;105(10):1394-7.

Karlsson UL, Augsburger JJ, Shields JA, Markoe AM, Brady LW, Woodleigh R. Recurrence of posterior uveal melanoma after 60Co episcleral plaque therapy. Ophthalmology. 1989 Mar;96(3):382-8.

Quivey JM, Augsburger J, Snelling L, Brady LW. 125I plaque therapy for uveal melanoma. Analysis of the impact of time and dose factors on local control. Cancer. 1996 Jun 1;77(11):2356-62.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Almony A, Breit S, Zhao H, Garcia-Ramirez J, Mansur DB, Harbour JW. Tilting of radioactive plaques after initial accurate placement for treatment of uveal melanoma. Arch Ophthalmol. 2008 Jan;126(1):65-70.

Responsible Party:	Archavan Almony, M.D., Barnes Retina Institute
ClinicalTrials.gov Identifier:	NCT00459849 History of Changes
Other Study ID Numbers:	HRPO# 07-0092
Study First Received:	April 11, 2007
Last Updated:	May 6, 2008
Health Authority:	United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on February 09, 2012