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

Uveal Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00459849
• Other study ID #: HRPO# 07-0092
• Status: Active, not recruiting
• Phase: N/A
• First received: April 11, 2007
• Last updated: May 6, 2008
• Start date: July 2000
• Est. completion date: July 2007

Study information

• Verified date: May 2008
• Source: Barnes Retina Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 175
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients with uveal melanoma treated with brachytherapy

Exclusion Criteria:

• Ciliary melanoma

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Uveal Melanoma
• Uveal Neoplasms

Intervention

Procedure:
• Intraoperative ultrasonography
Intraoperative ultrasonography will be used to determine plaque placement.

Locations

Country	Name	City	State
United States	Washington University in St. Louis School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Barnes Retina Institute

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plaque tilt using intraoperative ultrasonography		End of study	No
Primary	Local melanoma failure		End of study	No