Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
- - Patients being treated for head and neck cancers who require radiation therapy or intracranial tumors, over a 2 to 7 week period of time.
- - Age ≥ 18 years old.
- - Subjects are capable of giving informed consent or have an acceptable surrogate capable of giving consent on the subject's behalf.
- - Provide signed and dated informed consent form.
- - History of prior trauma or orthopedic surgery to the cervical vertebral column/spine, which may interfere with the RT planning process.
- - Patient requires a neck brace for medical reasons.
- - Skull or bony defect in the area contacting the immobilization straps.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Sidney Kimmel Cancer Center at Thomas Jefferson University|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Voichita Bar Ad, MD|
|Principal Investigator Affiliation||Sidney Kimmel Cancer Center at Thomas Jefferson University|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Brain and Nervous System, Intracranial Neoplasm, Head and Neck Cancer|
|Study Website:||View Trial Website|
- I. To assess the setup accuracy and reproducibility of the maskless immobilization device (MID) in patients being treated for head and neck cancers or intracranial tumors who require radiation therapy.
- I. To assess the patient comfort and quality of life with the MID compared to the thermoplastic mask.
Experimental: Supportive care (MID)
Patients undergo Computed Tomography (CT) simulation with thermoplastic mask and maskless immobilization device (MID) for radiation therapy (RT) planning on day 1. Patients undergo standard of care RT using thermoplastic mask only and cone-beam computed tomography (CBCT) imaging with thermoplastic mask and MID on day 8 and 15.
Procedure: - Computed Tomography
Undergo CT simulation
Device: - Medical Device
Given thermoplastic mask
Device: - Medical Device
Procedure: - Cone-Beam Computed Tomography
Undergo CBCT imaging
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107