Back to resultsTilting of Radioactive Plaques After Initial Accurate Placement for Treatment of Uveal Melanoma
Primary Purpose
Uveal Melanoma
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intraoperative ultrasonography
Sponsored by
About this trial
This is an interventional treatment trial for Uveal Melanoma focused on measuring Melanoma, Brachytherapy, Ultrasonography
Eligibility Criteria
Inclusion Criteria:
- All patients with uveal melanoma treated with brachytherapy
Exclusion Criteria:
- Ciliary melanoma
Sites / Locations
- Washington University in St. Louis School of Medicine
Outcomes
Primary Outcome Measures
Plaque tilt using intraoperative ultrasonography
Local melanoma failure
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00459849
Brief Title
Tilting of Radioactive Plaques After Initial Accurate Placement for Treatment of Uveal Melanoma
Official Title
Tilting of Radioactive Plaques After Initial Accurate Placement for Treatment of Uveal Melanoma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Unknown status
Study Start Date
July 2000 (undefined)
Primary Completion Date
July 2007 (Anticipated)
Study Completion Date
July 2007 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Barnes Retina Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveal Melanoma
Keywords
Melanoma, Brachytherapy, Ultrasonography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
175 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Intraoperative ultrasonography
Intervention Description
Intraoperative ultrasonography will be used to determine plaque placement.
Primary Outcome Measure Information:
Title
Plaque tilt using intraoperative ultrasonography
Time Frame
End of study
Title
Local melanoma failure
Time Frame
End of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients with uveal melanoma treated with brachytherapy
Exclusion Criteria:
Ciliary melanoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J W Harbour, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University in St. Louis School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Citations:
Citation
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.
Results Reference
background
PubMed Identifier
8414414
Citation
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. doi: 10.1016/s0161-6420(93)31446-6.
Results Reference
background
PubMed Identifier
3310986
Citation
Garretson 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.
Results Reference
background
PubMed Identifier
2710530
Citation
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. doi: 10.1016/s0161-6420(89)32882-x.
Results Reference
background
PubMed Identifier
8635107
Citation
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. doi: 10.1002/(SICI)1097-0142(19960601)77:113.0.CO;2-V.
Results Reference
background
PubMed Identifier
18195220
Citation
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. doi: 10.1001/archophthalmol.2007.9.
Results Reference
derived
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Tilting of Radioactive Plaques After Initial Accurate Placement for Treatment of Uveal Melanoma
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