Tilting of Radioactive Plaques After Initial Accurate Placement for Treatment of Uveal Melanoma
1 other identifier
interventional
175
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2000
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2000
CompletedFirst Submitted
Initial submission to the registry
April 11, 2007
CompletedFirst Posted
Study publicly available on registry
April 13, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedMay 9, 2008
May 1, 2008
7 years
April 11, 2007
May 6, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Plaque tilt using intraoperative ultrasonography
End of study
Local melanoma failure
End of study
Interventions
Intraoperative ultrasonography will be used to determine plaque placement.
Eligibility Criteria
You may qualify if:
- All patients with uveal melanoma treated with brachytherapy
You may not qualify if:
- Ciliary melanoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University in St. Louis School of Medicine
St Louis, Missouri, 63110, United States
Related Publications (6)
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.
BACKGROUNDChar 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. doi: 10.1016/s0161-6420(93)31446-6.
PMID: 8414414BACKGROUNDGarretson BR, Robertson DM, Earle JD. Choroidal melanoma treatment with iodine 125 brachytherapy. Arch Ophthalmol. 1987 Oct;105(10):1394-7. doi: 10.1001/archopht.1987.01060100096035.
PMID: 3310986BACKGROUNDKarlsson 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. doi: 10.1016/s0161-6420(89)32882-x.
PMID: 2710530BACKGROUNDQuivey 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. doi: 10.1002/(SICI)1097-0142(19960601)77:113.0.CO;2-V.
PMID: 8635107BACKGROUNDAlmony 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. doi: 10.1001/archophthalmol.2007.9.
PMID: 18195220DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
J W Harbour, MD
Washington University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 11, 2007
First Posted
April 13, 2007
Study Start
July 1, 2000
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
May 9, 2008
Record last verified: 2008-05