Intracranial Metastatic Disease From Any Solid MalignancyNCT05096286
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 study testing Ethos Therapy in people with Intracranial Metastatic Disease From Any Solid Malignancy, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Metastatic Disease From Any Solid Malignancy
- What is being tested?
- Ethos Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2022to 18 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of intracranial metastatic disease from solid malignancy that is amenable to and recommended for treatment with HA-WBRT by the treating physician.
- Patients may have had prior therapy for brain metastasis, including radiosurgery, prior whole brain RT, and surgical resection.
- Receipt of a contrast-enhanced brain MRI performed ≤21 days prior to study registration
- At least 18 years of age
- Karnofsky performance status ≥ 50
- Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable)
Who cannot join
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry. If pregnancy test is not clinically indicated as determined by treating physician or protocol principal investigator (PI), documentation of this exception is sufficient in lieu of a pregnancy test.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Feasibility and Safety of 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 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.
- Being tested
- Ethos Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethos TherapyDevice
FDA-approved treatment planning system
| Study group | Role | What they receive |
|---|---|---|
| Simulation-Free Hippocampal-Avoidance Whole Brain Radiotherapy | Experimental | * A diagnostic MRI-only, simulation-free plan will be generated from diagnostic brain MRI imaging, using a semi-automated, AI-assisted plan template within the Ethos Therapy system.
* The radiation prescription dose twill be 3.0 Gy daily over approximately 2 weeks for a total of 30.0 Gy (10 fractions). Receives: Device: Ethos Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through completion of treatment for all enrolled participants (estimated to be 24 months and 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start25 Jan 2022
- Primary completion18 Nov 2022
- Study completion18 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracranial Metastatic Disease From Any Solid MalignancyStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Varian Medical Systems
- Responsible party
- Sponsor
- Investigators
- Christopher Abraham, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05096286
- Sponsor's protocol ID
- 202110091
- Status last verified
- Nov 2022
- First submitted
- 14 Oct 2021
- Last updated
- 23 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 38580083
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of 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
- ClinicalTrials.gov ID
- NCT05096286
- Acronym / sponsor ID
- 202110091
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Varian Medical Systems
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 18 Nov 2022 (actual)
- Study completion
- 18 Nov 2022 (actual)
- First posted
- 27 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Simulation-Free Hippocampal-Avoidance Whole Brain Radiotherapy | Experimental | Device: Ethos Therapy* A diagnostic MRI-only, simulation-free plan will be generated from diagnostic brain MRI imaging, using a semi-automated, AI-assisted plan template within the Ethos Therapy system. * The radiation prescription dose twill be 3.0 Gy daily over approximately 2 weeks for a total of 30.0 Gy (10 fractions). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of intracranial metastatic disease from solid malignancy that is amenable to and recommended for treatment with HA-WBRT by the treating physician.
- Patients may have had prior therapy for brain metastasis, including radiosurgery, prior whole brain RT, and surgical resection.
- Receipt of a contrast-enhanced brain MRI performed ≤21 days prior to study registration
- At least 18 years of age
- Karnofsky performance status ≥ 50
Key exclusion criteria (1 listed)
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry. If pregnancy test is not clinically indicated as determined by treating physician or protocol principal investigator (PI), documentation of this exception is sufficient in lieu of a pregnancy test.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ethos TherapyFDA-approved treatment planning system | Device | Simulation-Free Hippocampal-Avoidance Whole Brain Radiotherapy |
Primary outcome
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
Time frame: Through completion of treatment for all enrolled participants (estimated to be 24 months and 2 weeks)
-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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
- Derived from this study: PubMed 38580083Kang 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.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Abraham, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ethos Therapy in people with Intracranial Metastatic Disease From Any Solid Malignancy, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Through completion of treatment for all enrolled participants (estimated to be 24 months and 2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05096286, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2022.