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

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT01944215

Collaborator

National Cancer Institute (NCI) (NIH)

154

Enrollment

Location

Arms

Duration (Months)

8.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Molecular Imaging	Dietary Supplement: Meal Other: Exercise Radiation: Sestamibi Drug: Caffeine Tablet Other: External Heating	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

154 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Sep 1, 2013

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm 4 - Fast vs Fast + External Heating MBI will be performed in 52 subjects after an overnight fast with 4-6 mCi Tc-99m sestamibi. The subject will receive the usual Mayo gown for breast imaging. A skin temperature sensor will be taped to the anterior of one breast and skin temperature will be recorded. The subject will be asked to sit for 15 minutes in the waiting room prior to injection of the Tc-99m sestamibi. Just prior to injection, skin temperature will be recorded again. After completion of the first study the subject will then be given a warm towel robe and a small heating pad to be placed over the chest area. After 30 minutes, skin temperature will be recorded again immediately prior to injection of the second dose of Tc-99m sestamibi. The second MBI study will then be performed.	Radiation: Sestamibi reduce radiation dose Other Names: Tc-99m Other: External Heating Heating Pad and warm blanket robe
Active Comparator: Arm 3 - Fasting vs. Fasting + Caffeine MBI will be performed in 52 subjects after an overnight fast with 4-6 mCi Tc-99m sestamibi. The subject will then be instructed to consume 200 mg caffeine in tablet form. This is equivalent to the caffeine content of an 8 oz brewed coffee from Starbucks. After 45 minutes after consumption of the caffeine tablet, patients will receive a second injection of 4-6 mCi Tc-99m sestamibi and a repeat MBI study will be performed.	Radiation: Sestamibi reduce radiation dose Other Names: Tc-99m Drug: Caffeine Tablet effect of caffeine Other Names: 200 mg Vivarin Tablet
Active Comparator: Arm 2-Resting vs. Exercising MBI will be performed in 25 subjects after an overnight fast with 4-6 mCi Tc-99m sestamibi. Patients will then be asked to perform moderate exercise on a treadmill for 6-10 minutes at a level of 70%-80% of maximum predicted heart rate. At ~10 minutes, patients will receive a second injection of 4-6 mCi Tc-99m sestamibi and a repeat MBI study will be performed.	Other: Exercise effect of exercise Radiation: Sestamibi reduce radiation dose Other Names: Tc-99m
Active Comparator: Arm 1-Fasting vs. Fed MBI will be performed in 25 subjects after an overnight fast with 4-6 mCi Tc-99m sestamibi. Patients will then be instructed to consume 8-16 fluid oz of Ensure (350-700 calories). At 30 minutes after consumption of the meal, patients will receive a second injection of 4-6 mCi Tc-99m sestamibi and a repeat MBI study will be performed.	Dietary Supplement: Meal effect of meal Other Names: Ensure Radiation: Sestamibi reduce radiation dose Other Names: Tc-99m

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts 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.

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)
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