Evaluation of the Effect of Fasting and Exercise on Uptake of Tc-99m Sestamibi in Breast Tissue

  • Study type:

    Interventional What is this?

    Describes 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: 13-004749
  • NCT ID:

    NCT01944215
  • Sponsor Protocol Number:

    13-004749

About this study

The primary objective of this study is to determine if exercise, fasting, or eating prior to the molecular breast imaging study will have an effect on the uptake of the tracer in the breast tissue.

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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion criteria:

Arm 1:

  1. Able to fast overnight or for 6 hours
  2. Non-diabetic
  3. Age > 40 years
  4. Negative pregnancy test, postmenopausal, or surgically sterilized
  5. Negative mammogram at Mayo Clinic within the last 15 months (defined as screening mammogram or subsequent diagnostic workup with BI-RADS 1 or 2 final assessment)
  6. No current breast concerns

Arm 2:

  1. Able to fast overnight or for 6 hours
  2. Able to perform light to moderate exercise on an exercise bike
  3. Non-diabetic and Body Mass Index < 25
  4. Age > 40 years and < 70 years
  5. Negative pregnancy test, postmenopausal, or surgically sterilized
  6. Negative mammogram at Mayo Clinic within the last 15 months (defined as screening mammogram or subsequent diagnostic workup with BI-RADS 1 or 2 final assessment)
  7. No current breast concerns 8. No history of coronary artery disease, angina, stroke or peripheral arterial disease.

Arm 3:

  1. Able to fast overnight or for 6 hours
  2. Willing to consume a dose of caffeine (200 mg), equivalent to that of an 8 oz Starbuck brewed coffee.
  3. Non-diabetic
  4. Age > 40 years
  5. Negative pregnancy test, postmenopausal, or surgically sterilized
  6. Negative mammogram at Mayo Clinic within the last 15 months (defined as screening mammogram or subsequent diagnostic workup with BI-RADS 1 or 2 final assessment)
  7. No current breast concerns

Arm 4:

  1. Able to fast overnight or for 6 hours
  2. Non-diabetic
  3. Age > 40 years
  4. Negative pregnancy test, postmenopausal, or surgically sterilized
  5. Negative mammogram at Mayo Clinic within the last 15 months (defined as screening mammogram or subsequent diagnostic workup with BI-RADS 1 or 2 final assessment)
  6. No current breast concerns

Exclusion Criteria:

  • Pregnancy test (if necessary) is not negative, or the patient is unable to complete the pregnancy test
  • Physically unable to sit upright and still remain still during two consecutive MBI studies over the course of a 2 hour period.
  • Have undergone unilateral or bilateral mastectomy
  • Breast implants or silicone injections
  • Are unable to understand and sign the consent form

Arm 2-also includes: Unable to perform light to moderate exercise for 12 minutes on a treadmill or a stationary bicycle

Arm 3: Unwilling to consume a 200 mg dose of caffeine

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Michael O'Connor, Ph.D.

Closed for enrollment

Tamara Hudson

(507)255-4377

hudson.tamara@mayo.edu