Use of Navigator Echoes for 4D-MRI
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-003321
Sponsor Protocol Number: 15-003321
About this study
The general aim of this proposal is to evaluate new non-significant risk (NSR) MRI technology in a clinical setting, specifically the use of preclinical (non-FDA-approved) sequences (including but not limited to bSSFP, SSFSE) which have been modified from their standard counterparts to include interleaved 1D body navigator pulses.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Volunteers:
- The volunteer population will be comprised of non-pregnant adults having age at least 18 years.
- Patients:
- The patient population will be comprised of individuals who present with a cancer diagnosis requiring radiotherapy in the chest or abdominal region
- Patients must be at least 7 years of age.
- For each case, the non-FDA approved sequence(s) will only be prescribed if there is evidence that this new MRI technology may add value to the current standard of care (namely, evaluation of breathing motion for radiation planning using 4D-CT alone.) .
- Only those patients having received 4D-CT as part of routine treatment planning will be considered for this pilot study
Exclusion Criteria:
- Volunteers:
- Pregnancy
- All exclusions associated with routine MRI safety screening apply.
- We will discourage persons who have previously experienced claustrophobia during MRI scans from enrolling.
- Patients:
- Pregnancy
- All exclusions associated with routine MRI safety screening apply.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Erik Tryggestad, Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available