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pinnacle3 radiation therapy planning system
Adac Laboratories
Summary: The Pinnacle3 is a radiation therapy planning system used primarily for optimizing treatment plans in radiotherapy. Key evidence highlights its application in intensity-modulated radiation therapy (IMRT) and volumetric modulated arc therapy (VMAT) with studies showing its efficacy in sparing organs at risk.
FDA Clearance Information
Pathway
510K
Number
K032724 ↗
Decision Date
October 9, 2003
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Pinnacle3 radiation therapy planning system was cleared by the FDA through the 510(k) pathway on October 9, 2003. It is manufactured by Adac Laboratories and classified as a Class 2 medical device.
What It Is
The Pinnacle3 is a sophisticated software system designed for planning radiation therapy treatments. It allows clinicians to create precise treatment plans by optimizing dose distribution to target tumors while minimizing exposure to surrounding healthy tissues.
Clinical Applications
Commonly used in scenarios requiring precise radiation dose delivery, such as in the treatment of prostate, cervical, and brain cancers. It is particularly valuable in intensity-modulated radiation therapy (IMRT) and volumetric modulated arc therapy (VMAT) for its ability to enhance treatment accuracy.
Evidence Summary
The literature includes 11 studies ranging from 2016 to 2024, encompassing randomized controlled trials, prospective and retrospective studies, and case series. These studies focus on the system's dosimetric capabilities and clinical outcomes in various cancer treatments.
Reported Outcomes
Published studies report that the Pinnacle3 system effectively improves dose distribution in radiation therapy, particularly in IMRT and VMAT. It has shown benefits in sparing organs at risk, such as the hippocampus in whole-brain radiation therapy, and optimizing treatment plans for liver and cervical cancers.
Safety Profile
Reported complications include potential inaccuracies in dose delivery due to system limitations or user error. However, no significant adverse events directly attributed to the Pinnacle3 system were highlighted in the reviewed studies.
Evidence Limitations
The evidence is limited by the small sample sizes and the retrospective nature of some studies. Further research is needed to validate findings across diverse patient populations and to explore long-term outcomes and safety.
Frequently Asked Questions
What are the clinical indications for Pinnacle3?
The Pinnacle3 is indicated for use in planning radiation therapy treatments, particularly in intensity-modulated and volumetric modulated arc therapies for various cancers.
What outcomes have been reported in clinical studies?
Studies report improved dose distribution and organ-at-risk sparing in treatments planned with Pinnacle3, particularly in IMRT and VMAT for prostate, cervical, and brain cancers.
What complications have been reported?
Reported complications include potential inaccuracies in dose delivery, though no significant adverse events directly linked to the system were noted in the studies.
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.