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

NCT ID: NCT00459849

Last Updated: 2008-05-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 175 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-07-31
• Study Completion Date: 2007-07-31

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.

Conditions

Uveal Melanoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Intraoperative ultrasonography

Intraoperative ultrasonography will be used to determine plaque placement.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• All patients with uveal melanoma treated with brachytherapy

Exclusion Criteria

• Ciliary melanoma

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Barnes Retina Institute

OTHER

Sponsor Role: lead

Responsible Party

Barnes Retina Institute

Principal Investigators

J W Harbour, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University in St. Louis School of Medicine

St Louis, Missouri, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 8414414 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 3310986 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2710530 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8635107 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 18195220 (View on PubMed)

Other Identifiers

HRPO# 07-0092

Identifier Type: -

Identifier Source: org_study_id