Status:
TERMINATED
Contrast-Enhanced Cone Beam Breast CT for Diagnostic Breast Imaging
Lead Sponsor:
Koning Corporation
Conditions:
Breast Cancer
Eligibility:
FEMALE
35+ years
Phase:
PHASE2
PHASE3
Brief Summary
Up to one hundred (100) female patients will be enrolled and consented to participate in the study. These women will be enrolled from screening assigned BIRADS 0, patient complaint, or referral for se...
Eligibility Criteria
Inclusion
- Female sex
- Age 35 years or older
- Any ethnicity
- Have an abnormality detected by Breast Self Exam (BSE), or Clinical Breast Exam (CBE), or have an abnormality detected by an imaging modality.
- Will undergo study imaging within four weeks from the date of diagnostic mammography, prior to breast biopsy (if needed).
- Able to provide informed consent
- Post-menopausal, surgically sterile, or effective birth control. For women of childbearing potential, negative pregnancy test or has signed pregnancy test waiver
- If required by standard of care, eGFR \>45 within 48 hours to 6 weeks of CE-CBBCT exam
Exclusion
- Pregnancy
- Lactation
- Unknown pregnancy status AND
- has refused pregnancy testing and
- has refused to sign a pregnancy test waiver
- Women who are unable or unwilling to understand or to provide informed consent
- Women with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker.
- Women who are unable to tolerate study constraints.
- Women who have received radiation treatments to the thorax or breast area for malignant and nonmalignant conditions, such as (but not limited to):
- Treatment for enlarged thymus gland as an infant
- Irradiation for benign breast conditions, including breast inflammation after giving birth
- Treatment for Hodgkin's disease
- Women who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.
- Women who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to):
- Tuberculosis
- Severe scoliosis
- Additional Exclusion Criteria Due To Contrast Injection:
- Allergic to iodinated contrast material
- Previous non-ionic contrast reaction
- Any conditions below regardless of eGFR
- Renal Disease
- Chronic renal dysfunction
- Renal Transplant (or waiting for a transplant)
- One kidney or other birth defect
- Polycystic Kidneys
- Renal Tumor/Renal Cancer
- History of liver failure/cirrhosis/liver transplant/pending liver transplant
- Congestive heart failure
- Multiple myeloma
- Hyperthyroidism
- Pheochromocytoma
- Sickle Cell Disease
- Asthma requiring daily use of inhaler Additional exclusion criteria due to machine limitations
- Patient's body weight is over the limit of the scanner table (440 lbs or 200kg)
Key Trial Info
Start Date :
September 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2021
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03354611
Start Date
September 10 2018
End Date
September 1 2021
Last Update
March 16 2023
Active Locations (2)
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1
UR Medicine Breast Imaging
Rochester, New York, United States, 14623
2
Knoxville Comprehensive Breast Center
Knoxville, Tennessee, United States, 37909