Molecular ImagingPhase 1NCT01944215
Evaluation of the Effect of Fasting and Exercise on Uptake of Tc-99m Sestamibi in Breast Tissue
A Phase 1 study testing Meal, Exercise and Sestamibi in people with Molecular Imaging, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Molecular Imaging
- What is being tested?
- Meal, Exercise and Sestamibi
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Apr 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Molecular Imaging
- Being tested
- Meal, Exercise, Sestamibi, Caffeine Tablet, External Heating
- Keywords
- Normal subjects, Female, Molecular Breast Imaging, Fasting, Exercise, Tracer Uptake, Tc-99m Sestamibi, Prandial status, metabolic status, negative mammogram, Caffeine, External Warming
- Medical subject headings
- Fasting, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MealDietary supplement
Also called Ensure
effect of meal
ExerciseOther
effect of exercise
SestamibiRadiation
Also called Tc-99m
reduce radiation dose
Caffeine TabletDrug
Also called 200 mg Vivarin Tablet
effect of caffeine
External HeatingOther
Heating Pad and warm blanket robe
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Meal; Radiation: Sestamibi |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Molecular ImagingStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Michael O'Connor, Mayo Clinic
- Investigators
- Michael K O'Connor, PhD, R-D, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01944215
- Sponsor's protocol ID
- 13-004749
- Other IDs
- R44CA143716
- Status last verified
- Dec 2015
- First submitted
- 4 Sep 2013
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21045179Swanson 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.
PubMed 30479286O'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.
PubMed 25613340
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Fasting and Exercise on Uptake of Tc-99m Sestamibi in Breast Tissue
- ClinicalTrials.gov ID
- NCT01944215
- Acronym / sponsor ID
- 13-004749
- Conditions
- Molecular Imaging
- Keywords
- Normal subjects, Female, Molecular Breast Imaging, Fasting, Exercise, Tracer Uptake, Tc-99m Sestamibi, Prandial status
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 17 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 4 - Fast vs Fast + External Heating | Active comparator | Radiation: Sestamibi, Other: External HeatingMBI 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. |
| Arm 3 - Fasting vs. Fasting + Caffeine | Active comparator | Radiation: Sestamibi, Drug: Caffeine TabletMBI 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. |
| Arm 2-Resting vs. Exercising | Active comparator | Other: Exercise, Radiation: SestamibiMBI 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. |
| Arm 1-Fasting vs. Fed | Active comparator | Dietary Supplement: Meal, Radiation: SestamibiMBI 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MealAlso: Ensureeffect of meal | Dietary supplement | Arm 1-Fasting vs. Fed |
| Exerciseeffect of exercise | Other | Arm 2-Resting vs. Exercising |
| SestamibiAlso: Tc-99mreduce radiation dose | Radiation | Arm 1-Fasting vs. Fed, Arm 2-Resting vs. Exercising, Arm 3 - Fasting vs. Fasting + Caffeine, Arm 4 - Fast vs Fast + External Heating |
| Caffeine TabletAlso: 200 mg Vivarin Tableteffect of caffeine | Drug | Arm 3 - Fasting vs. Fasting + Caffeine |
| External HeatingHeating Pad and warm blanket robe | Other | Arm 4 - Fast vs Fast + External Heating |
Primary outcome
Uptake of this radiopharmaceutical in breast tissue
Time frame: 2 Days
Quantitative measurements of Tc-99m sestamibi uptake will be performed to measure the relative change in uptake between the two MBI scans.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
- Results publication: PubMed 21045179Rhodes 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.
- Derived from this study: PubMed 30479286Swanson 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.
- Derived from this study: PubMed 25613340O'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.
- Molecular Breast Imaging-Mayo ClinicLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael K O'Connor, PhD, R-D principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Meal, Exercise and Sestamibi in people with Molecular Imaging, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of this radiopharmaceutical in breast tissue (time frame: 2 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01944215, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2017.