1. To determine the ability of the Sicel Technologies, Inc (STI) sensor to remain anchored in the malignant and normal tissue. 2. To determine the morbidity associated with the minimally invasive implant procedure of the sensor. 3. To determine the correlation of in situ dosimetry with computer generated dosimetric calculations. 4. To determine the biocompatibility associated with an implantable device. The treatment of cancer is often empirical. The schedule and dose level of two of the most utilized therapeutic modalities (radiation and chemotherapy) are determined not by specific physiological and kinetic parameters but on the tolerance of the normal tissues of the body. The normal tissue surrounding the tumor governs the dose level of radiation and the scheduling is mostly dependent on the tolerance of the more actively proliferating tissues of the body. The total dose of radiation and the volume irradiated influence the degree of control that can be obtained. Therefore it is important to determine the actual dose delivered to insure that the malignant tissue receives a tumoricidal dose while attempting to keep the dose to normal tissue within tolerance. Currently there are no implantable in vivo dosimeters available that can monitor the dose delivered to the tumor and/or normal tissue. STI has developed an implantable device platform to monitor in real time, specific parameters related to the biology of malignant tissue and the various treatments thereof. The device is designed to measure the dose of radiation delivered at the site of the intended target and as such is designated as a dose verification system (DVS). Once inserted at the periphery of the tumor and/or in normal tissue, it will measure and transmit, on command, the dose delivered to the area containing the sensor. The primary purpose of the DVS will be to provide a real-time monitoring system for radiation therapy at clinical points of interest. It will ensure that the patient is receiving the daily-prescribed dose in vivo and thereby improve the ability to monitor the dose delivered. The system provides an excellent complement to any quality assurance program. This telemetric implantable technology is designed to serve as a platform for additional novel oncologic applications (i.e., radiolabeled drug uptake, pH, etc.).

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Exploratory/Developmental Grants (R21)
Project #
5R21CA097859-02
Application #
6754551
Study Section
Clinical Oncology Study Section (CONC)
Program Officer
Deye, James
Project Start
2003-06-13
Project End
2005-05-31
Budget Start
2004-06-23
Budget End
2005-05-31
Support Year
2
Fiscal Year
2004
Total Cost
$180,000
Indirect Cost
Name
Sicel Technologies, Inc.
Department
Type
DUNS #
059043807
City
Morrisville
State
NC
Country
United States
Zip Code
27560
Scarantino, Charles W; Prestidge, Bradley R; Anscher, Mitchel S et al. (2008) The observed variance between predicted and measured radiation dose in breast and prostate patients utilizing an in vivo dosimeter. Int J Radiat Oncol Biol Phys 72:597-604
Beyer, Gloria P; Scarantino, Charles W; Prestidge, Bradley R et al. (2007) Technical evaluation of radiation dose delivered in prostate cancer patients as measured by an implantable MOSFET dosimeter. Int J Radiat Oncol Biol Phys 69:925-35
Scarantino, Charles W; Rini, Christopher J; Aquino, Migdalia et al. (2005) Initial clinical results of an in vivo dosimeter during external beam radiation therapy. Int J Radiat Oncol Biol Phys 62:606-13
Black, Robert D; Scarantino, Charles W; Mann, Gregory G et al. (2005) An analysis of an implantable dosimeter system for external beam therapy. Int J Radiat Oncol Biol Phys 63:290-300