Clinical Evaluation Of MP26 Features in Adults

Overview

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:

  1. Are adults (aged 18 or older);
  2. 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);
  3. Are able to undergo PET/MR within the tracer validity time frame after radiotracer injection;
  4. Can hear without assistive devices and have necessary mental capacity to follow study instructions;
  5. Are willing and able to provide written informed consent;
  6. Are considered eligible for MRI and PET exams, according to site institutional safety policies.

Exclusion Criteria:

  1. Were previously enrolled in the study;
  2. If female, are pregnant or of undetermined pregnancy status;
  3. Cannot fit safely in the device (>55 cm axial diameter or >227 kgs body weight);
  4. Have implants or attached medical devices that could be unsafe for MRI;
  5. 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
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CLS-20304711

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