MBI Response toTam
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-008736
NCT ID: NCT02979301
Sponsor Protocol Number: 16-008736
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Female, age 40 or older at the time of enrollment
- Most recent MBI examination, performed within 3 years of enrollment, showed moderate or marked background parenchymal uptake
- Mammogram performed within 24 months prior to enrollment that is available for comparison
- Willing and able to return for MBI following 30 days of low-dose tamoxifen
- If able to become pregnant
- Negative pregnancy test within 48 hours prior to study MBI exam(s)
- Agrees to avoid pregnancy during the study and for at least 2 months after study participation ends, by abstinence, barrier method, or nonhormonal contraception.
- Understands and signs the consent form
Exclusion Criteria:
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:
- Systemic hormonal therapy (oral or transdermal patch formulations)
- Hormonal contraception (oral, transdermal, implanted, or injected formulations) Hormonal IUDs are allowed
- Selective estrogen receptor modulators (tamoxifen, raloxifene, or toremifene)
- Aromatase inhibitors (anastrazole, letrozole, or exemestane)
- GnRH analogs
- Prolactin inhibitors
- Androgens or antiandrogens
- Anticoagulants or "blood thinners" (warfarin, heparin, rivaroxaban and other novel anticoagulants)
- 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 smoker 12) Known carrier of BRCA1 or BRCA2 genetic mutation or known DNA repair defect 13) Has high blood pressure
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Carrie Hruska, Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available