Set up and Monitoring of Patients Receiving Proton RadiationDS02NCT01971866
Camera Based System to Monitor Patient Movement During Radiation Treatment
An observational study of Set up and Monitoring of Patients Receiving Proton Radiation, run by University of Florida at 1 site in United States.
Trial summary
This study aims to investigate the advantages of using AlignRT, a commercially available, FDA approved camera-based imaging system for proton therapy patients prior to and during their radiation treatment delivery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Set up and Monitoring of Patients Receiving Proton Radiation
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Jul 2015
- Phase
- Observational
- 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
Study population: Patients who are undergoing proton radiation therapy at UFPTI
Who may be able to join
- Patients with tumors of the brain, head and neck, thorax, upper abdomen, posterior spine/sacrum and extremities
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Proton Therapy Institute
Jacksonville, Florida, 32206
About this study
Official title: Improving Safety and Accuracy of Proton Therapy by Use of Camera-Based Patient Localization System
This study aims to investigate the advantages of using AlignRT, a commercially available, FDA approved camera-based imaging system for proton therapy patients prior to and during their radiation treatment delivery.
- Keywords
- Proton radiation, AlignRT
What is being measured
The primary outcome is the main question the study is designed to answer.
Paired difference between image accuracy plan data from the AlignRT system compared to the current x-ray based imaging system.
Enrollment and analysis will be restricted to adult patients with tumors of the brain, head and neck region, thorax, upper abdomen, or posterior spine/sacrum. Primary outcome will be analyzed by paired t-test.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: Slow enrollment, feasibility issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Set up and Monitoring of Patients Receiving Proton RadiationStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Mamalui-Hunter, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01971866
- Sponsor's protocol ID
- UFPTI 1215-DS02
- Acronym
- DS02
- Status last verified
- Jan 2016
- First submitted
- 17 Oct 2013
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Safety and Accuracy of Proton Therapy by Use of Camera-Based Patient Localization System
- ClinicalTrials.gov ID
- NCT01971866
- Acronym / sponsor ID
- DS02 / UFPTI 1215-DS02
- Keywords
- Proton radiation, AlignRT
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow enrollment, feasibility issues
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 29 Oct 2013 (estimated)
- 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 study aims to investigate the advantages of using AlignRT, a commercially available, FDA approved camera-based imaging system for proton therapy patients prior to and during their radiation treatment delivery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are undergoing proton radiation therapy at UFPTI
Key inclusion criteria (1 listed)
- Patients with tumors of the brain, head and neck, thorax, upper abdomen, posterior spine/sacrum and extremities
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Paired difference between image accuracy plan data from the AlignRT system compared to the current x-ray based imaging system.
Time frame: 3 months
Enrollment and analysis will be restricted to adult patients with tumors of the brain, head and neck region, thorax, upper abdomen, or posterior spine/sacrum. Primary outcome will be analyzed by paired t-test.
Results and safety
The study was stopped early (reason given: Slow enrollment, feasibility issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
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.
Maria Mamalui-Hunter, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Set up and Monitoring of Patients Receiving Proton Radiation, run by University of Florida 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 1 inclusion and 0 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: stopped early, as of the sponsor's last update on 27 Jan 2016. 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 was stopped early (reason given: Slow enrollment, feasibility issues). Results are not available in the source record.
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?
Paired difference between image accuracy plan data from the AlignRT system compared to the current x-ray based imaging system. (time frame: 3 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 27 Jan 2016.