Clinical trial NCT03354611: Contrast-Enhanced Cone Beam Breast CT for Diagnostic Breast Imaging
Official title: Contrast-Enhanced Cone Beam Breast CT for Diagnostic Breast Imaging
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Breast Cancer
Lead sponsor: Koning Corporation
Sponsor class: INDUSTRY
First posted: 2017-11-28
Enrollment: 21
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects in this group will be enrolled from screening assigned BIRADS 0, patient complaint, or referral for second opinion. The enrolled patient will accept CE-CBBCT scans within 4 weeks of her diagnostic mammography and before breast biopsy if biopsy is needed.
Primary purpose: DIAGNOSTIC

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 second opinion. The enrolled patient will accept CE-CBBCT scans within 4 weeks of her diagnostic mammography and before breast biopsy if biopsy is needed. The final diagnostic workup outcome of these enrolled patients needs to include at least 30 confirmed cancers cases.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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)

Primary outcomes:
measure: Breast lesions
timeFrame: Within 4 weeks after the imaging acquisition if finished if there is a suspicious finding in the images.
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: UR Medicine Breast Imaging
state: New York
city: Knoxville
country: United States
facility: Knoxville Comprehensive Breast Center
state: Tennessee
Study officials:
References:
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