High-Resolution Lower Dose Dedicated Breast Computed Tomography (CT) (LowerDoseBCT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03954431|
Recruitment Status : Not yet recruiting
First Posted : May 17, 2019
Last Update Posted : May 22, 2019
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- Lesion conspicuity [ Time Frame: 18 months ]The conspicuity of lesions will be evaluated using CE-BCT.
- Contrast enhancement quantification [ Time Frame: 18 months ]The amount of contrast enhancement with CE-BCT will be quantified.
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
|Contact: Carol Stuehmemail@example.com|
|United States, Arizona|
|University of Arizona||Not yet recruiting|
|Tucson, Arizona, United States, 85724|
|Contact: Carol Stuehm 520-626-8618 firstname.lastname@example.org|
|Principal Investigator: Srinivasan Vedantham, PhD|
|Sub-Investigator: Andrew Karellas, PhD|
|Principal Investigator:||Srinivasan Vedantham, PhD||University of Arizona|
|Principal Investigator:||Andrew Karellas, PhD||University of Arizona|