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oncentra manual low dose rate treatment planning
Nucletron
Summary: Oncentra Manual Low Dose Rate Treatment Planning by Nucletron is a device used in brachytherapy for cancer treatment. It is FDA-cleared and supported by studies focusing on breast and oral cancer applications.
FDA Clearance Information
Pathway
510K
Number
K113102 ↗
Decision Date
December 12, 2011
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Oncentra Manual Low Dose Rate Treatment Planning device was cleared by the FDA via the 510(k) pathway on December 12, 2011. It is manufactured by Nucletron and classified as a Class 2 device.
What It Is
The Oncentra Manual Low Dose Rate Treatment Planning device is designed for use in brachytherapy, a form of radiotherapy where a radiation source is placed inside or next to the area requiring treatment. It is intended for precise radiation dose delivery in cancer treatment.
Clinical Applications
This device is commonly used in the treatment of early-stage breast cancer and oral cancer. It is particularly useful in scenarios requiring targeted radiation therapy with minimal exposure to surrounding healthy tissues.
Evidence Summary
The available literature includes two studies: one retrospective study from 2024 and another study from 2018 using Monte Carlo simulation. These studies focus on breast and oral cancer treatment using brachytherapy.
Reported Outcomes
Published studies report that the use of Oncentra in breast cancer treatment can reduce treatment volumes and toxicity. In oral cancer, the device helps estimate whole-body radiation exposure, although specific efficacy outcomes were not detailed.
Safety Profile
Reported complications include potential whole-body radiation exposure in oral cancer treatment, as estimated by Monte Carlo simulations. No specific adverse events were detailed in the studies provided.
Evidence Limitations
The evidence is limited by the small number of studies and lack of detailed outcomes and safety data. Further research is needed to establish comprehensive efficacy and safety profiles across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Oncentra Manual Low Dose Rate Treatment Planning?
The device is indicated for use in brachytherapy for early-stage breast cancer and oral cancer.
What outcomes have been reported in clinical studies?
Studies report reduced treatment volumes and favorable toxicity in breast cancer treatment, with whole-body radiation exposure estimation in oral cancer.
What complications have been reported?
Safety data indicate potential whole-body radiation exposure in oral cancer treatment, but specific adverse events were not detailed.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.