HDR Brachytherapy for Intraocular Melanoma

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R43CA128153-01A1
Agency Tracking Number: CA128153
Amount: $106,801.00
Phase: Phase I
Program: SBIR
Awards Year: 2008
Solicitation Year: 2008
Solicitation Topic Code: N/A
Solicitation Number: PHS2007-2
Small Business Information
113 TEAL ST, ST. ROSE, LA, 70087
DUNS: 069542181
HUBZone Owned: Y
Woman Owned: Y
Socially and Economically Disadvantaged: Y
Principal Investigator
 (978) 340-0156
Business Contact
Phone: (504) 464-9471
Email: johnm@spec150.com
Research Institution
DESCRIPTION (provided by applicant): HDR Brachytherapy for Intraocular Melanoma - Project Summary/Abstract The overall objective of this Phase I program is to develop a brachytherapy system for the treatment of intraocular melanoma that reduces hospitaliza tion time, provides improved dosimetry to reduce complications, improves safety for the clinician and reduces cost. This will be achieved through the development of an improved high dose rate brachytherapy system based on the low- energy gamma ray source 1 69 Ytterbium. Such development would eliminate the long hospitalization required with the current low dose rate treatment and reduce the radiation exposure to the surgeon and other hospital personnel. This would also achieve the benefits of superior dose o ptimization with its collateral improvement in therapeutic response, along with potentially better treatment efficacy available with afterloaded high dose rate temporary brachytherapy sources. We further believe that the specific radiological properties of this radionuclide will result in reduced dose to the sclera than can be achieved with the currently-available radionuclides, and thereby will reduce the complications from this procedure. We aim to demonstrate that high dose rate brachytherapy using 169 Y tterbium can be an effective treatment method for this cancer. Choroidal melanoma is the most common primary ocular malignancy, with some 1500 new cases reported yearly in the United States. These tumors are both sight- and life-threatening, with approxima tely 10% to 30% five-year mortality rate owing to systemic metastasis, depending on tumor size. The National Eye Institute- and National Cancer Institute-sponsored Collaborative Ocular Melanoma Study (COMS), a prospective multicenter clinical trial to judg e treatment efficacy brachytherapy v. enucleation in the context of mortality, showed that brachytherapy conveyed as good a survival rate as enucleation, in both a statistical and practical sense. However, current eye plaques, containing 125Iodine or 103Pa lladium brachytherapy seeds must be left in place from 5 to 12 days, and require a second surgery to remove the plaque from the patient. The low average photon emission energies from 125 Iodine and 103 Palladium result in a high dose to the sclera in order to deliver the desired dose to the apex of the tumor. This results in risk of damage and complications. The development of a high dose rate brachytherapy system using 169 Ytterbium can be practically and economically implemented and will overcome the shor tcomings of the current treatment method while providing clinical benefit. HDR Brachytherapy for Intraocular Melanoma - Project Narrative The clinical implementation of high dose rate 169 Ytterbium brachytherapy will benefit patients by resulting in shorte r treatment of certain types of eye cancer, and potentially fewer complications. This will also lead to greater safety to the physicians performing this procedure and greater comfort to the patients by reducing their hospital stay from a week to a day. It will also result in reduced cost for this procedure.

* Information listed above is at the time of submission. *

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