A Study to Evaluate User Feedback Using Affirm® Contrast Biopsy

Overview

About this study

The purpose of this study is to collect user and subject feedback on the design, use and operation of Affirm® Contrast Biopsy.

 

 

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:

  • Females aged 40 years of age or older.
  • Recommended for biopsy.
  • Have had a suspicious finding on previous contrast enhanced imaging or have lesions that may be occult under other modalities.
  • Subject is able to read, understand, and sign the study specific informed consent form after the nature of the study has been fully explained to them

Exclusion Criteria:

  • Subjects who require a Legally Authorized Representative (LAR)for Informed Consent.
  • Subjects who, based on the physician’s judgement, may be at increased risk for complications associated with renal function, anticoagulant therapy, or bleeding disorders.
  • Subjects who have had a previous allergic reaction to IV contrast agent.

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 Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Bhavika Patel, M.D.

Open for enrollment

Contact information:

Sonia Robertson

(480) 342-6677

Robertson.Sonia@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions