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High-Resolution Lower Dose Dedicated Breast Computed Tomography (CT) (LowerDoseBCT)

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ClinicalTrials.gov Identifier: NCT03954431
Recruitment Status : Not yet recruiting
First Posted : May 17, 2019
Last Update Posted : May 22, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Arizona

Brief Summary:
This study is being performed to find out if a new kind of breast imaging (called contrast-media enhanced breast CT or CE-BCT) can help doctors to see the small structures in breast tissue more clearly. This study is also being performed to find out if using the CE-BCT will separate cancers from non-cancers. This is important because 25% to 35% of structures that do not appear to be normal and are removed from the breast (biopsied) for studying under a microscope turn out to be cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Diagnostic Test: Contrast-media enhanced breast CT(CE-BCT) Drug: Iodinated Contrast Agent Phase 1 Phase 2

Detailed Description:

The breast imaging device that will be used in this study (breast computed tomography or BCT) is not FDA-approved for this use so this is a research study. The machine has been redesigned to see if doctors can see smaller structures and use a lower radiation dose.

An x-ray dye will be injected through a needle in the subject's arm before the test. The FDA has approved this dye for other uses, but not for this exam, so the use of the dye is also research.

The breast CT device will take multiple pictures of the subject's breast and create a 3-D image of the breast. It does not compress or squash the breast like a mammogram.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Study of High-resolution, Lower Dose Dedicated Breast CT for Visualization and Diagnosis of Breast Imaging Reporting And Data System (BIRADS) 4/5 Findings.
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CE-BCT
All subjects will undergo contrast-enhanced breast CT (CE-BCT)
Diagnostic Test: Contrast-media enhanced breast CT(CE-BCT)
The breast CT device will take multiple pictures of the subject's breast and create a 3-D image of the breast.
Other Name: CE-BCT

Drug: Iodinated Contrast Agent
The CE-BCT diagnostic test will use an iodinated contrast agent. This drug is FDA approved for contrast-enhanced x-ray imaging examinations, though not specifically for dedicated breast computed tomography.
Other Name: Iodinated contrast media




Primary Outcome Measures :
  1. Lesion conspicuity [ Time Frame: 18 months ]
    The conspicuity of lesions will be evaluated using CE-BCT.


Secondary Outcome Measures :
  1. Contrast enhancement quantification [ Time Frame: 18 months ]
    The amount of contrast enhancement with CE-BCT will be quantified.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • who were asymptomatic and 40 years of age or older (typical screening age range) at the time of the screening exam that prompted the recall
  • who were assigned BI-RADS category 4 or 5 after x-ray based diagnostic work-up such as mammography or digital breast tomosynthesis (DBT)
  • who have no known adverse reaction to iodinated contrast media
  • who satisfy University of Arizona (UA) - Banner University Medical Center (BUMC), Department of Medical Imaging policy for administration of iodinated contrast media for computed tomography (CT) imaging, which may include a blood draw for renal function assessment.

Exclusion criteria:

  • Males,
  • women less than 40 years old,
  • women unable to self-consent,
  • prisoners,
  • pregnant or lactating women (If premenopausal, urine pregnancy test will be used to determine pregnancy)
  • 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, frail, or unable to cooperate;
  • women who weigh more than 440 lbs (200 Kg), which is the weight limit for the patient support table of the BCT system;
  • women who have received radiation treatments to the thorax 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, and 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 with glomerular filtration rate (GFR) less than 30 mL/min/1.73 m^2 indicative of impaired kidney function,
  • women with known allergies to contrast media,
  • women who have received large number of diagnostic x-ray examinations for monitoring of disease such as (but not limited to) tuberculosis, and severe scoliosis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03954431


Contacts
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Contact: Carol Stuehm 5206268318 carols@email.arizona.edu

Locations
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United States, Arizona
University of Arizona Not yet recruiting
Tucson, Arizona, United States, 85724
Contact: Carol Stuehm    520-626-8618    carols@email.arizona.edu   
Principal Investigator: Srinivasan Vedantham, PhD         
Sub-Investigator: Andrew Karellas, PhD         
Sponsors and Collaborators
University of Arizona
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Srinivasan Vedantham, PhD University of Arizona
Principal Investigator: Andrew Karellas, PhD University of Arizona

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Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT03954431     History of Changes
Other Study ID Numbers: 1903399639
R01CA199044 ( U.S. NIH Grant/Contract )
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes