Brain CancerDragonNCT05427214
Imaging Study on Halcyon 4.0 System for Patients Receiving Radiation Therapy
A study testing Halcyon 4.0 system in people with Brain Cancer and Head and Neck Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This prospective imaging study is evaluating the feasibility of using the Halcyon 4.0 radiotherapy system for radiation therapy planning in patients with cancer. The Halcyon 4.0 system has been engineered to decrease the image acquisition time and the radiation exposure, but the system has not yet been clinically… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Cancer, Head and Neck Cancer, Lung Cancer
- What is being tested?
- Halcyon 4.0 system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2022to 17 Oct 2024
- 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
Eligibility Criteria:
- Planning to receive radiation therapy to one of the following sites:
- Head and neck/brain (n=10)
- Thorax (n=10)
- Abdomen (n=10)
- Pelvis (n=10)
- At least 18 years of age
- If the patient will be receiving IV contrast on study: Adequate renal function as defined by a serum creatinine < 1.4, or, for patients with chronic kidney disease, a stable serum creatinine < 2.0. Note: if no IV contrast will be administered on study, patient may enroll without creatinine level documented.
- If the patient is a woman of childbearing potential, a negative pregnancy test must be obtained. Contraceptive use is not an adequate documentation of no chance of pregnancy.
- Able to understand and willing to sign an IRB approved written informed consent document.
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: A Prospective Imaging Study of Target Definition and Simulation-free Planning Workflows on the Halcyon 4.0 System for Patients Receiving Radiation Therapy
This prospective imaging study is evaluating the feasibility of using the Halcyon 4.0 radiotherapy system for radiation therapy planning in patients with cancer. The Halcyon 4.0 system has been engineered to decrease the image acquisition time and the radiation exposure, but the system has not yet been clinically validated for use in radiation planning. This pilot study will evaluate images obtained on the Halcyon 4.0 system to assess if the quality is sufficient for radiation treatment plan construction.
- Conditions
- Brain Cancer, Head and Neck Cancer, Lung Cancer, Gastric Cancer, Ovarian Cancer, Colon Cancer
- Being tested
- Halcyon 4.0 system
- Keywords
- radiation therapy, halcyon, brain radiation, thoracic radiation, abdominal radiation, pelvic radiation
- Medical subject headings
- Brain Neoplasms, Head and Neck Neoplasms, Lung Neoplasms, Stomach Neoplasms, Ovarian Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Halcyon 4.0 systemDevice
During each of the 1 or more imaging sessions, no more than 6 images total will be acquired. Only 5 images total across all of the imaging sessions will be used toward the study endpoint.
| Study group | Role | What they receive |
|---|---|---|
| Halcyon 4.0 imaging | Experimental | Patients planning to receive radiation therapy to the head and neck/brain, thorax, abdomen, or pelvis will undergo imaging on the Halcyon 4.0 system. Patients will return for a minimum of 2 sessions over 9 weeks, with a cumulative total of 10 images being collected. Receives: Device: Halcyon 4.0 system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of images that are of sufficient quality for patient primary treatment plan construction
If the treatment target and surrounding organs at risk can be visualized and contoured for treatment planning purposes and a treatment plan created that meets the stated objectives ( or better than the stated objectives), then the kV CBCT images will be deemed feasible.
Measured: At 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start19 Aug 2022
- Primary completion17 Oct 2024
- Study completion17 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain CancerStudies 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
- 52 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
- Pamela Samson, M.D., MPHS, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427214
- Sponsor's protocol ID
- 202205118
- Acronym
- Dragon
- Status last verified
- Oct 2024
- First submitted
- 16 Jun 2022
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Imaging Study of Target Definition and Simulation-free Planning Workflows on the Halcyon 4.0 System for Patients Receiving Radiation Therapy
- ClinicalTrials.gov ID
- NCT05427214
- Acronym / sponsor ID
- Dragon / 202205118
- Conditions
- Brain Cancer, Head and Neck Cancer, Lung Cancer, Gastric Cancer, Ovarian Cancer, Colon Cancer
- Keywords
- radiation therapy, halcyon, brain radiation, thoracic radiation, abdominal radiation, pelvic radiation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Varian Medical Systems
- Study start
- 19 Aug 2022 (actual)
- Primary completion
- 17 Oct 2024 (actual)
- Study completion
- 17 Oct 2024 (actual)
- First posted
- 22 Jun 2022 (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.
This prospective imaging study is evaluating the feasibility of using the Halcyon 4.0 radiotherapy system for radiation therapy planning in patients with cancer. The Halcyon 4.0 system has been engineered to decrease the image acquisition time and the radiation exposure, but the system has not yet been clinically validated for use in radiation planning. This pilot study will evaluate images obtained on the Halcyon 4.0 system to assess if the quality is sufficient for radiation treatment plan construction.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Halcyon 4.0 imaging | Experimental | Device: Halcyon 4.0 systemPatients planning to receive radiation therapy to the head and neck/brain, thorax, abdomen, or pelvis will undergo imaging on the Halcyon 4.0 system. Patients will return for a minimum of 2 sessions over 9 weeks, with a cumulative total of 10 images being collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Halcyon 4.0 systemDuring each of the 1 or more imaging sessions, no more than 6 images total will be acquired. Only 5 images total across all of the imaging sessions will be used toward the study endpoint. | Device | Halcyon 4.0 imaging |
Primary outcome
Percentage of images that are of sufficient quality for patient primary treatment plan construction
Time frame: At 9 weeks
If the treatment target and surrounding organs at risk can be visualized and contoured for treatment planning purposes and a treatment plan created that meets the stated objectives ( or better than the stated objectives), then the kV CBCT images will be deemed feasible.
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 21 Oct 2024.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Pamela Samson, M.D., MPHS 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 Halcyon 4.0 system in people with Brain Cancer and Head and Neck Cancer, 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?
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 21 Oct 2024. 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?
Percentage of images that are of sufficient quality for patient primary treatment plan construction (time frame: At 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2024.