High Background Uptake on MBI
Conditions
Brief summary
The study will examine whether changes in background parenchymal uptake (BPU) on molecular breast imaging (MBI) can be induced by short-term use of low-dose tamoxifen. Women who have previously had high BPU on MBI will be recruited. Participants will take low-dose tamoxifen for a 30-day period, with post-tamoxifen MBI in order to investigate the impact of tamoxifen on BPU.
Interventions
DRUGTamoxifen
5 mg or 10 mg tamoxifen per day for 30 days.
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
The following are requirements for entry into the study: 1. Female, age 40 or older at the time of enrollment 2. Most recent MBI examination, performed within 3 years of enrollment, showed moderate or marked background parenchymal uptake 3. Mammogram performed within 12 months prior to enrollment that is available for comparison 4. Willing and able to return for MBI following 30 days of low-dose tamoxifen 5. If able to become pregnant 1. Negative pregnancy test within 48 hours prior to study MBI exam(s) 2. Agrees to avoid pregnancy during the study and for at least 2 months after study participation ends, by abstinence, barrier method, or nonhormonal contraception. 6. Understands and signs the consent form \-
Exclusion criteria
Subjects will be excluded if any of the following characteristics are present: 1\) Evidence of suspected breast disease as defined by positive findings or recommendation for short-interval follow-up on most recent breast imaging (including mammography, MBI, MRI, ultrasound, etc.) not yet resolved prior to enrollment 2) Breast biopsy or breast surgery performed 6 months prior to enrollment 3) Bilateral breast implants or status post-bilateral prophylactic mastectomy 4) Pregnant or lactating 5) Current or recent use (within 6 months prior to enrollment) of any of the following drugs: 1. Systemic hormonal therapy (oral or transdermal patch formulations) 2. Hormonal contraception (oral, transdermal, implanted, or injected formulations) 3. Selective estrogen receptor modulators (tamoxifen, raloxifene, or toremifene) 4. Aromatase inhibitors (anastrazole, letrozole, or exemestane) 5. GnRH analogs 6. Prolactin inhibitors 7. Androgens or antiandrogens 8. Anticoagulants or blood thinners (warfarin, heparin, rivaroxaban and other novel anticoagulants) 9. Drugs known to be strong inhibitors of CYP2D6, the major P450 enzyme that metabolizes tamoxifen, including: * bupropion (Wellbutrin) * fluoxetine (Prozac) * paroxetine (Paxil) * quinidine (Quinidex) 6) Personal history of any type of malignancy, with the exclusion of non-melanoma skin cancer, diagnosed prior to enrollment 7) Personal history or strong family history of blood clots in legs or lungs (also known as deep vein thrombosis or pulmonary embolism) 8) Personal history of transient ischemic attack (TIA) or cerebrovascular accident (CVA) 9) Active proliferative disorders of the endometrium such as atypical hyperplasia, history of active endometriosis, unresected polyps 10) Any type of retinal disorders or severe cataract 11) Current or former smoker 12) Known carrier of BRCA1 or BRCA2 genetic mutation or known DNA repair defect.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Background Parenchymal Uptake (BPU) on Molecular Breast Imaging (MBI) | 30 days | An image analysis tool to obtain a quantitative measure of background parenchymal uptake (BPU) was applied to pre-tamoxifen and post-tamoxifen MBI exams. The percent change in BPU from pre-tamoxifen to post-tamoxifen MBI was determined. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tamoxifen 5 mg/Day Women with a history of high background uptake on MBI were enrolled.
A baseline MBI was performed at Day 0. Women then took 5 mg tamoxifen per day for 30 days, followed by a post-tamoxifen MBI exam. | 10 |
| Tamoxifen 10 mg/Day Women with a history of high background uptake on MBI were enrolled.
A baseline MBI was performed at Day 0. Women then took 10 mg tamoxifen per day for 30 days, followed by a post-tamoxifen MBI exam. | 11 |
| Total | 21 |
Baseline characteristics
| Characteristic | Tamoxifen 5 mg/Day | Total | Tamoxifen 10 mg/Day |
|---|---|---|---|
| Age, Continuous | 47.3 years STANDARD_DEVIATION 4.4 | 47.7 years STANDARD_DEVIATION 4.1 | 48.1 years STANDARD_DEVIATION 4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 21 Participants | 11 Participants |
| Region of Enrollment United States | 10 participants | 21 participants | 11 participants |
| Sex: Female, Male Female | 10 Participants | 21 Participants | 11 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
Primary
Change in Background Parenchymal Uptake (BPU) on Molecular Breast Imaging (MBI)
An image analysis tool to obtain a quantitative measure of background parenchymal uptake (BPU) was applied to pre-tamoxifen and post-tamoxifen MBI exams. The percent change in BPU from pre-tamoxifen to post-tamoxifen MBI was determined.
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tamoxifen 5 mg/Day | Change in Background Parenchymal Uptake (BPU) on Molecular Breast Imaging (MBI) | 0.0 percent change in BPU | Standard Deviation 21 |
| Tamoxifen 10 mg/Day | Change in Background Parenchymal Uptake (BPU) on Molecular Breast Imaging (MBI) | -12 percent change in BPU | Standard Deviation 11 |