A Study of Contribution of 3D Models in Resection of Renal Cell Cancer
Overview
Tab Title Description
Study type
ObservationalDescribes 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: 15-002821
Sponsor Protocol Number: 15-002821
About this study
The purpose of this study is to evaluate the impact on surgical planning and patient acceptance and understanding of 3D kidney tumor models prior to surgery.
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:
Subjects are required to meet the following inclusion criteria:
- Male and female subjects between 3 months and 88 years of age, inclusive.
- Diagnosis of a renal tumor.
- Renal tumor surgery is being considered.
- Ability to provide written, informed consent prior to initiation of any study-related procedures, and ability, in the opinion of the principle investigator, to comply with all.
Exclusion Criteria:
Subjects will be excluded if they meet any of the following exclusion criteria prior to enrollment:
- Clinically significant concomitant systemic disease that in the surgeon’s opinion the utilization of 3D models may not be appropriate.
- Surgery is planned for a date that will not allow time enough for the 3D model to be made (usually 2 weeks).
- The preoperative imaging study does not meet the basic minimum requirements necessary to the create an acceptable 3D model.
- If the patient only has inadequate outside CT or MR images for use in creating 3D model.
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 Bradley Leibovich, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available