Cancer of PancreasNCT04008537
Daily Imaging, Target Identification, and Simulated Computed Tomography-Based Stereotactic Adaptive Radiotherapy Workflow in a Novel Ring Gantry Radiotherapy Device
A study testing Ring gantry kV-CBCT combined with linear accelerator in people with Cancer of Pancreas and Cancer of Pelvis, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The investigators propose here to evaluate the feasibility of a novel cone-beam CT (CBCT)-guided online adaptive radiotherapy (ART) workflow on the Halcyon device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Pancreas, Cancer of Pelvis, Cancer of Abdomen
- What is being tested?
- Ring gantry kV-CBCT combined with linear accelerator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2019to 8 Mar 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
- At least one disease site deemed to be suitable for simulated treatment with online adaptive radiotherapy per radiation oncology evaluation.
- Scheduled to receive radiation therapy to the thorax (n = 8), pancreas (n = 8), non-pancreas abdomen (n = 8), or pelvis (n = 8).
- At least 18 years of age
- Able to understand and willing to sign an IRB-approved written informed consent document.
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 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: A Pilot Study of Daily Imaging, Target Identification, and Simulated Computed Tomography-Based Stereotactic Adaptive Radiotherapy Workflow in a Novel Ring Gantry Radiotherapy Device
The investigators propose here to evaluate the feasibility of a novel cone-beam CT (CBCT)-guided online adaptive radiotherapy (ART) workflow on the Halcyon device.
- Being tested
- Ring gantry kV-CBCT combined with linear accelerator
- Medical subject headings
- Pancreatic Neoplasms, Pelvic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ring gantry kV-CBCT combined with linear acceleratorDevice
Also called Halcyon
Each imaging session will be less than one hour, and is expected to take no more than 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Halcyon kV CBCT imaging | Experimental | -Each patient will undergo five Halcyon kV CBCT imaging sessions that will then be utilized to simulate the CBCT-guided online ART workflow. Halcyon imaging will be scheduled as per the patient's schedule and availability, with intent but not mandate for imaging on the same days as clinical treatments, preceding clinical treatment. Multiple images may be acquired in one session but no more than 6 Halcyon kV CBCT images will be acquired per day. No more than 6 additional Halcyon kV CBCT images will be acquired in one imaging session and no more than 10 total additional Halcyon kV CBCT images for the duration of the study Receives: Device: Ring gantry kV-CBCT combined with linear accelerator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the device as measured by successful completion of the full CBCT-guided online ART workflow, from volumetric imaging through phantom delivery in at least 90% of attempted fractions
Measured: Completion of ART workflow in all enrolled participants (estimated to be 30 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start4 Sep 2019
- Primary completion8 Mar 2022
- Study completion8 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of PancreasStudies 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
- 37 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
- Lauren Henke, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008537
- Sponsor's protocol ID
- 201908024
- Status last verified
- Apr 2022
- First submitted
- 27 Jun 2019
- Last updated
- 19 Apr 2022
- 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 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Daily Imaging, Target Identification, and Simulated Computed Tomography-Based Stereotactic Adaptive Radiotherapy Workflow in a Novel Ring Gantry Radiotherapy Device
- ClinicalTrials.gov ID
- NCT04008537
- Acronym / sponsor ID
- 201908024
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Varian Medical Systems
- Study start
- 4 Sep 2019 (actual)
- Primary completion
- 8 Mar 2022 (actual)
- Study completion
- 8 Mar 2022 (actual)
- First posted
- 5 Jul 2019 (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.
The investigators propose here to evaluate the feasibility of a novel cone-beam CT (CBCT)-guided online adaptive radiotherapy (ART) workflow on the Halcyon device.
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 kV CBCT imaging | Experimental | Device: Ring gantry kV-CBCT combined with linear accelerator-Each patient will undergo five Halcyon kV CBCT imaging sessions that will then be utilized to simulate the CBCT-guided online ART workflow. Halcyon imaging will be scheduled as per the patient's schedule and availability, with intent but not mandate for imaging on the same days as clinical treatments, preceding clinical treatment. Multiple images may be acquired in one session but no more than 6 Halcyon kV CBCT images will be acquired per day. No more than 6 additional Halcyon kV CBCT images will be acquired in one imaging session and no more than 10 total additional Halcyon kV CBCT images for the duration of the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least one disease site deemed to be suitable for simulated treatment with online adaptive radiotherapy per radiation oncology evaluation.
- Scheduled to receive radiation therapy to the thorax (n = 8), pancreas (n = 8), non-pancreas abdomen (n = 8), or pelvis (n = 8).
- At least 18 years of age
- Able to understand and willing to sign an IRB-approved written informed consent document.
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 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 |
|---|---|---|
| Ring gantry kV-CBCT combined with linear acceleratorAlso: HalcyonEach imaging session will be less than one hour, and is expected to take no more than 15 minutes. | Device | Halcyon kV CBCT imaging |
Primary outcome
Feasibility of the device as measured by successful completion of the full CBCT-guided online ART workflow, from volumetric imaging through phantom delivery in at least 90% of attempted fractions
Time frame: Completion of ART workflow in all enrolled participants (estimated to be 30 months)
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 19 Apr 2022.
- 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.
Lauren Henke, 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 Ring gantry kV-CBCT combined with linear accelerator in people with Cancer of Pancreas and Cancer of Pelvis, 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 4 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 19 Apr 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 device as measured by successful completion of the full CBCT-guided online ART workflow, from volumetric imaging through phantom delivery in at least 90% of attempted fractions (time frame: Completion of ART workflow in all enrolled participants (estimated to be 30 months)). 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 19 Apr 2022.