Molecular Imaging
Conditions
Keywords
Normal subjects, Female, Molecular Breast Imaging, Fasting, Exercise, Tracer Uptake, Tc-99m Sestamibi, Prandial status, metabolic status, negative mammogram, Caffeine, External Warming
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTMeal
effect of meal
OTHERExercise
effect of exercise
RADIATIONSestamibi
reduce radiation dose
DRUGCaffeine Tablet
effect of caffeine
OTHERExternal Heating
Heating Pad and warm blanket robe
Sponsors
National Cancer Institute (NCI)
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uptake of this radiopharmaceutical in breast tissue | 2 Days | Quantitative measurements of Tc-99m sestamibi uptake will be performed to measure the relative change in uptake between the two MBI scans. |
Countries
United States
Outcome results
None listed