None listed
Conditions
Brief summary
Background: Current radiation therapy requires a radiation beam to be rotated around a patient. An alternative approach is to rotate a patient while the radiation beam remains stationary. Such a system may greatly reduce the costs of radiation therapy and would simplify the incorporation of radiation therapy with Magnetic Resonance Imaging (MRI), which would allow therapists to deliver treatment with greater precision. Since this approach has never been utilised for either radiation therapy or in combination with MRI, the acceptance of the rotation to cancer patients is not known. It is also unclear how this rotation will impact the position and shape of the body’s internal organs and subsequently on the radiation therapy. The rotation will have no impact on the organ functions. This study aims to bring patient rotation in MRI closer to reality, which would reduce the costs and complexity of radiation therapy. The participant rotation device used for this study is not a medically approved device. All other devices used in the study, including the MRI, are medically approved. Who is this for? You may be eligible for this study if you have a current or previous diagnosis of cancer. Study Details: The study will be discussed with you at the time of your clinic appointment or prior to the MRI imaging session. You will have the opportunity to discuss the study with a qualified physician. Written informed consent will be obtained prior to registration on the study and before any assessments are performed. Prior to the MRI imaging, you will be asked to complete a questionnaire, where you will be required to rate your current levels of anxiety, claustrophobia and motion sickness. The questionnaire will take approximately 5 minutes to complete. During the imaging session, you will be asked to lie down on the couch on your back, supported by cushions under your back, head and knees. You will then be fastened with belts around the legs, across the chest and across the forehead and will be made as secure as possible without causing discomfort. Once you are comfortable, three inflatable air-cushions will be placed around you, the air cushions will then be inflated to support the weight of your body and restrict movement during the rotation. You will then be inserted into the MRI by the clinical investigators. They will then manually rotate the device to 45 degrees, and reposition you back in the MRI bore for each scan. The device will not rotate during the imaging.The whole imaging session should last approximately 40 minutes. You will be monitored constantly during the study in addition to holding a distress buzzer. Following the imaging, you will again be asked to complete the questionnaire to assess any change in your levels of anxiety and motion sickness. At the end of the session you will be asked a series of open ended questions relating to your experience. The full session will take 2 hours.
Interventions
To quantify anatomical deformations due to horizontal rotation and to assess participant acceptance of rotation within an MRI imaging system.
A 3 Tesla dedicated radiotherapy MRI scanner will be used to acquire the images. Images will be acquired using two scans: a higher quality ‘SPACE’ 3D isotropic T2-weighted turbo spin echo sequence at the zero degree couch position (TE=102 ms, TR=1470 ms, turbo factor=15, bandwidth 780Hz/pixel, slice thickness=1.7 mm) and a faster 2D T2-weighted turbo spin
To quantify anatomical deformations due to horizontal rotation and to assess participant acceptance of rotation within an MRI imaging system. A 3 Tesla dedicated radiotherapy MRI scanner will be used to acquire the images. Images will be acquired using two scans: a higher quality ‘SPACE’ 3D isotropic T2-weighted turbo spin echo sequence at the zero degree couch position (TE=102 ms, TR=1470 ms, turbo factor=15, bandwidth 780Hz/pixel, slice thickness=1.7 mm) and a faster 2D T2-weighted turbo spin echo sequence for the images at varying couch angles (TE=96 ms, TR=8280 ms, turbo factor 15, slice thickness 4 mm, bandwidth 400Hz/pixel). A one off MRI imaging session which takes 2 hours at most including set-up, imaging and set-down. Participants will be divided between varying anatomical sites including but not limited to Cervix, Prostate, Head and Neck, Thorax Radiologist with Investigator assistance will administer the intervention
Sponsors
Liverpool Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Greater than or equal to 18 years of age 2. Willing and able to comply with all study requirements 3. Must be able to read and understand English 4. Signed, written informed consent 5. Must fall within height of 190cm, width and depth of 32cm x 45cm and weight limits of 100kg max the participant rotation system 6. Completed MRI safety screening form Inclusion Criteria for Cancer Participant Volunteers 1. A current or previous diagnosis of cancer, any stage 2. Must have sufficient mobility to get into/out of the participant rotation system, as determined by the clinical investigator 3. Currently or previously being treated with radiotherapy Inclusion Criteria for Healthy Volunteers 1. Current Staff member of Liverpool Hospital or Ingham Institute or University Student
Exclusion criteria
1. Pregnant women 2. Mentally impaired participants or participants for whom attaining informed consent would be difficult (including language barriers) 3. Unable to undergo an MRI examination or has MRI contraindications 4. Participants who have been clinically diagnosed with severe claustrophobia
Outcome results
None listed