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NCT05096286 · ClinicalTrials.gov registry record · NA

Simulation-Free Hippocampal-Avoidance Whole Brain Radiotherapy Using Diagnostic MRI-Based and Cone Beam Computed Tomography-Guided On-Table Adaptive Planning in a Novel Ring Gantry Radiotherapy Device

A NA study, sponsored by Washington University School of Medicine.

Completed
Registry status
NA
Development phase
10
Enrollment target

NCT05096286: Completed NA study, sponsored by Washington University School of Medicine.

NCT05096286 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05096286, a NA study, has completed, sponsored by Washington University School of Medicine.

COMPLETED
Registry status
NA
Development phase
10 participants
Enrollment target

Study Summary

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.

Primary Outcome

-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-b

Interventions

  • DEVICE Ethos Therapy

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2022-01-25
Est. Completion 2022-11-18
Phase NA

What the finished NCT05096286 record still lists

NCT05096286 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Ethos Therapy is the first listed.

NCT05096286 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05096286 about?

NCT05096286 is a clinical study titled "Simulation-Free Hippocampal-Avoidance Whole Brain Radiotherapy Using Diagnostic MRI-Based and Cone Beam Computed Tomography-Guided On-Table Adaptive Planning in a Novel Ring Gantry Radiotherapy Device". 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 cognitiv...

What is the current status of trial NCT05096286?

This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2022-01-25. Estimated completion is 2022-11-18.

What interventions are being tested in trial NCT05096286?

The interventions under investigation include: Ethos Therapy (DEVICE).

Who is sponsoring clinical trial NCT05096286?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05096286's enrollment target sits among peer trials

10 1927th of 2000 higher than 26 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05096286, the US trial registry maintained by the National Library of Medicine. NCT05096286 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.