Clinical trial NCT01944215: Evaluation of the Effect of Fasting and Exercise on Uptake of Tc-99m Sestamibi in Breast Tissue
Official title: Evaluation of the Effect of Fasting and Exercise on Uptake of Tc-99m Sestamibi in Breast Tissue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Molecular Imaging
Keywords: Normal subjects
Female
Molecular Breast Imaging
Fasting
Exercise
Tracer Uptake
Tc-99m Sestamibi
Prandial status
metabolic status
negative mammogram
Caffeine
External Warming
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-09-17
Enrollment: 154
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Uptake of this radiopharmaceutical in breast tissue
timeFrame: 2 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Michael K O'Connor, PhD, R-D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rhodes DJ, Hruska CB, Phillips SW, Whaley DH, O'Connor MK. Dedicated dual-head gamma imaging for breast cancer screening in women with mammographically dense breasts. Radiology. 2011 Jan;258(1):106-18. doi: 10.1148/radiol.10100625. Epub 2010 Nov 2.
citation: Swanson TN, Tran TD, Hruska CB, Solberg CM, Rhodes DJ, Hunt KN, Conners AL, O'Connor MK. Patient Acceptance of Half-dose Vs. Half-time Molecular Breast Imaging. J Med Imaging Radiat Sci. 2018 Mar;49(1):39-43. doi: 10.1016/j.jmir.2017.08.003. Epub 2017 Sep 13.
citation: O'Connor MK, Hruska CB, Tran TD, Swanson T, Conners AL, Jones K, Rhodes DJ. Factors influencing the uptake of 99mTc-sestamibi in breast tissue on molecular breast imaging. J Nucl Med Technol. 2015 Mar;43(1):13-20. doi: 10.2967/jnmt.114.150128. Epub 2015 Jan 22.