Brain TumorNCT01202539
Real-time Assessment of Frameless Intrafraction Motion
An observational study of Brain Tumor, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of this study is to assess the ability of a modified thermoplastic mask system in keeping an individual head stationary for a predefined amount of time. The investigators hope to know if the modified mask is study enough, and also if the modification on the mask will allow the investigator see and track… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Brain Tumor
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Sep 2011
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Potential subjects will be recruited by the Oregon Health and Science University study investigators.
Who may be able to join
- Healthy individual
- Age > 18 years.
- Males and females of all races and ethnic groups
Who cannot join
- Severe claustrophobia
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: Use of Real-time Infrared Reflective Marker Tracking and Surface Texture Mapping to Assess the Integrity of a Novel Thermoplastic Mask System for Frameless Immobilization
The purpose of this study is to assess the ability of a modified thermoplastic mask system in keeping an individual head stationary for a predefined amount of time. The investigators hope to know if the modified mask is study enough, and also if the modification on the mask will allow the investigator see and track the individual's movement underneath the mask by means of a camera that can detect light reflected from the individual. Participants will lay down on their backs and their heads will be held in place with the mask system for approximately 1 hour.
- Conditions
- Brain Tumor
- Medical subject headings
- Brain Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2011 (estimated)
- Study completionSep 2011 (estimated)
Why it stopped: Enrollment challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James A. Tanyi, Oregon Health and Science University
- Investigators
- James A. Tanyi, Ph.D., Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01202539
- Sponsor's protocol ID
- OHSU IRB00006460
- Status last verified
- Oct 2019
- First submitted
- 15 Sep 2010
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Real-time Infrared Reflective Marker Tracking and Surface Texture Mapping to Assess the Integrity of a Novel Thermoplastic Mask System for Frameless Immobilization
- ClinicalTrials.gov ID
- NCT01202539
- Acronym / sponsor ID
- OHSU IRB00006460
- Conditions
- Brain Tumor
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Enrollment challenges
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 16 Sep 2010 (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.
The purpose of this study is to assess the ability of a modified thermoplastic mask system in keeping an individual head stationary for a predefined amount of time. The investigators hope to know if the modified mask is study enough, and also if the modification on the mask will allow the investigator see and track the individual's movement underneath the mask by means of a camera that can detect light reflected from the individual. Participants will lay down on their backs and their heads will be held in place with the mask system for approximately 1 hour.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Potential subjects will be recruited by the Oregon Health and Science University study investigators.
Key inclusion criteria (3 listed)
- Healthy individual
- Age > 18 years.
- Males and females of all races and ethnic groups
Key exclusion criteria (1 listed)
- Severe claustrophobia
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
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
- Oregon Health and Science UniversityLink provided by the sponsor.
Related trials for Brain Tumor
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
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.
James A. Tanyi, Ph.D. principal investigator
Oregon Health and Science University
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 Brain Tumor, run by Oregon Health and Science University 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 3 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: withdrawn, as of the sponsor's last update on 3 Oct 2019. 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 withdrawn before enrolling participants, so there are no results.
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.
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 3 Oct 2019.