Contrast-Enhanced Cone Beam Breast CT for Diagnostic Breast Imaging

Koning Health

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Contrast Dye, Iodinated; Radiation: Contrast Enhanced Cone Beam Breast CT Scan

Study type: Interventional

Funder types: Industry

Identifiers

NCT03354611

16-01

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: Female

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Diagnostic Workup

Experimental group

Description:

The subjects will first have a pre-contrast CBBCT scan. Iodinated contrast will be injected intravenously, and then another CBBCT scans will be performed to capture the tumor vasculature enhancement.

Treatment:

Drug: Contrast Dye, Iodinated

Radiation: Contrast Enhanced Cone Beam Breast CT Scan