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

Mayo Clinic

Status and phase: Completed; Phase 1

Conditions: Molecular Imaging

Treatments: Other: External Heating; Radiation: Sestamibi; Drug: Caffeine Tablet; Other: Exercise; Dietary Supplement: Meal

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01944215

13-004749

R44CA143716 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 154 patients

Sex: Female

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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154 participants in 4 patient groups

Arm 4 - Fast vs Fast + External Heating

Active Comparator group

Description:

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.

Treatment:

Radiation: Sestamibi

Other: External Heating

Arm 3 - Fasting vs. Fasting + Caffeine

Active Comparator group

Description:

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.

Treatment:

Drug: Caffeine Tablet

Radiation: Sestamibi

Arm 2-Resting vs. Exercising

Active Comparator group

Description:

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.

Treatment:

Radiation: Sestamibi

Other: Exercise

Arm 1-Fasting vs. Fed

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Meal

Radiation: Sestamibi