Clinical Evaluation Of MP26 Features in Adults
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: 16-005718
NCT ID: NCT02927327
Sponsor Protocol Number: 114.03-2016-GES-0001
About this study
The purpose of the study is to collect representative clinical images (head and whole-body scans) of demonstrated diagnostic quality using the next-generation SIGNA PET/MR device equipped with investigational software components in adult population. The images and summary data from this study are intended for use in regulatory submission.
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:
- Are adults (aged 18 or older);
- Have preexisting clinical indication for PET/CT or PET/MR with radiotracer injection (for subjects that will undergo ZTE procedures, a preexisting clinical indication for PET/CT is required);
- Are able to undergo PET/MR within the tracer validity time frame after radiotracer injection;
- Can hear without assistive devices and have necessary mental capacity to follow study instructions;
- Are willing and able to provide written informed consent;
- Are considered eligible for MRI and PET exams, according to site institutional safety policies.
Exclusion Criteria:
- Were previously enrolled in the study;
- If female, are pregnant or of undetermined pregnancy status;
- Cannot fit safely in the device (>55 cm axial diameter or >227 kgs body weight);
- Have implants or attached medical devices that could be unsafe for MRI;
- Have medical conditions or require urgent care that could make it unsafe to participate
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 Kemp, Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available