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| Name | Class |
|---|---|
| Varian Medical Systems | INDUSTRY |
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Hippocampal-avoidance whole brain radiation therapy (HA-WBRT) limits radiation dose to the hippocampal-avoidance region while still delivering therapeutic doses of radiation to the whole brain. When used in addition to prophylactic memantine, this technique has been shown to better preserve cognitive function in patients with brain metastases outside of the hippocampal-avoidance region with no difference in intracranial progression-free and overall survival. However, HA-WBRT requires considerably longer planning time when compared to conventional WBRT (5-10 business days, compared to next-day), and studies have shown that brain metastases can grow in as rapidly as one week.
A proposed solution for quicker initiation of HA-WBRT is the use of simulation-free radiation treatment planning, in which pre-existing diagnostic images are used to generate the radiation treatment plan (as opposed to acquiring planning-specific image sets). This will be paired with the use of artificial intelligence (AI)-assisted semi-automated planning using the FDA-approved treatment planning system called Ethos Therapy. The investigators have developed an institutional HA-WBRT auto-planning template, which has been retrospectively validated for the creation of plans that are compliant with the gold standard NRG Oncology CC001 clinical trial and are dosimetrically comparable to traditional HA-WBRT plans. Semi-automated plans will be constructed using diagnostic imaging, which will be refined as needed (adjustments for difference in gross head positioning between diagnostic imaging and radiation treatment positioning, etc.) while the patient is on the treatment table at fraction one using adaptive radiation planning. Adaptive radiotherapy is standard-of-care practice for other disease sites.
The purpose of this study is to demonstrate the feasibility and safety of a simulation-free workflow for HA-WBRT that is AI-assisted and semi-automated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simulation-Free Hippocampal-Avoidance Whole Brain Radiotherapy | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ethos Therapy | Device | FDA-approved treatment planning system |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the simulation-free hippocampal-avoidance whole brain radiotherapy (HA-WBRT) as measured by the successful completion of the simulation-free HA-WBRT workflow through treatment delivery | -Success will be defined as HA-WBRT plan creation and delivery of fraction 1 using the simulation-free study workflow in one on-table attempt, without having to resort to use of a backup, simulation-based plan in at least 70% of treated patients. Unsuccessful planning and workflow delivery will be defined as multiple attempts for sim-free planning and on-table delivery without creation of a plan meeting planning constraints such that the study workflow is abandoned and a traditional simulation-based planning workflow is used instead. | Through completion of treatment for all enrolled participants (estimated to be 24 months and 2 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Abraham, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38580083 | Derived | Kang KH, Price AT, Reynoso FJ, Laugeman E, Morris ED, Samson PP, Huang J, Badiyan SN, Kim H, Brenneman RJ, Abraham CD, Knutson NC, Henke LE. A Pilot Study of Simulation-Free Hippocampal-Avoidance Whole Brain Radiation Therapy Using Diagnostic MRI-Based and Online Adaptive Planning. Int J Radiat Oncol Biol Phys. 2024 Aug 1;119(5):1422-1428. doi: 10.1016/j.ijrobp.2024.03.039. Epub 2024 Apr 3. |
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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Individual participant data that underlies the results reported in the article publication, after deidentification (text, tables, figures, and appendices) may be shared with investigators whose proposed use of the data (for individual participant data meta-analysis) has been approved by an independent review committee identified for this purpose.
Beginning 9 months and ending 36 months following article publication.
Proposals may be submitted up to 36 months following article publication to the principal investigator of the study.
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