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

NCT01944215 | Completed Phase 1

• 2 other identifiers: 13-004749R44CA143716
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Uptake of this radiopharmaceutical in breast tissue

  Quantitative measurements of Tc-99m sestamibi uptake will be performed to measure the relative change in uptake between the two MBI scans.

  2 Days

Study Arms (4)

Arm 4 - Fast vs Fast + External Heating

ACTIVE COMPARATOR

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; Other: External Heating

Arm 3 - Fasting vs. Fasting + Caffeine

ACTIVE COMPARATOR

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; Drug: Caffeine Tablet

Arm 2-Resting vs. Exercising

ACTIVE COMPARATOR

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; Radiation: Sestamibi

Arm 1-Fasting vs. Fed

ACTIVE COMPARATOR

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; Radiation: Sestamibi

Interventions

Meal DIETARY_SUPPLEMENT

effect of meal

Also known as: Ensure

Arm 1-Fasting vs. Fed

Exercise OTHER

effect of exercise

Arm 2-Resting vs. Exercising

Sestamibi RADIATION

reduce radiation dose

Also known as: Tc-99m

Arm 1-Fasting vs. Fed; Arm 2-Resting vs. Exercising; Arm 3 - Fasting vs. Fasting + Caffeine; Arm 4 - Fast vs Fast + External Heating

Caffeine Tablet DRUG

effect of caffeine

Also known as: 200 mg Vivarin Tablet

Arm 3 - Fasting vs. Fasting + Caffeine

External Heating OTHER

Heating Pad and warm blanket robe

Arm 4 - Fast vs Fast + External Heating

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (3)

• 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.

  PMID: 21045179 RESULT

• 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.

  PMID: 30479286 DERIVED

• 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.

  PMID: 25613340 DERIVED

Related Links

• Molecular Breast Imaging-Mayo Clinic

MeSH Terms

Conditions

Fasting; Motor Activity

Interventions

Meals; Exercise; Technetium Tc 99m Sestamibi; Technetium; Caffeine

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nitriles; Organic Chemicals; Organotechnetium Compounds; Organometallic Compounds; Elements, Radioactive; Elements; Inorganic Chemicals; Metals, Heavy; Transition Elements; Radioisotopes; Isotopes; Metals; Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Michael K O'Connor, PhD, R-D

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: September 4, 2013
• First Posted: September 17, 2013
• Study Start: September 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: April 18, 2017

Record last verified: 2015-12

Locations

US (1)