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

Location:

Rochester, Minn.

Trial status:
Open for Enrollment
Why is this study being done?

The primary objective of this study is to determine if exercise, fasting, or eating prior to a molecular breast imaging study will have an effect on the uptake of the radiotracer Tc-99m sestamibi in the breast tissue. Tc-99m sestamibi is primarily extracted by the liver. Changes in hepatic blood flow may therefore influence the amount of radiotracer available for uptake in the breast tissue.

Who is eligible to participate?

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

Last updated:
3/25/2014
NCT ID:
NCT01944215
IRB Number:
13-004749