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Contrast-Enhanced Cone Beam Breast CT for Diagnostic Breast Imaging

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: NCT03354611
Recruitment Status : Recruiting
First Posted : November 28, 2017
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
Koning Corporation

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: Contrast Enhanced Cone Beam Breast CT Scan Drug: Contrast Dye, Iodinated Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Contrast-Enhanced Cone Beam Breast CT for Diagnostic Breast Imaging
Actual Study Start Date : September 10, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diagnostic Workup
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.
Radiation: Contrast Enhanced Cone Beam Breast CT Scan
  • Pre-contrast scan
  • Begin contrast injection (and saline chaser)
  • Post-contrast Scan. Start time of post-contrast CE-CBBCT scan is 90-200 seconds after start of injection, depending on method of contrast delivery (bolus vs hand injection)

Drug: Contrast Dye, Iodinated
1.5-2ml/kg body weight (100 ml maximum) of a low osmolar, nonionic, 300-350 mgI/ml iodinated contrast agent, will be injected at a rate of ~2.0 ml/s, for a total injection time of 30-60 seconds (for a 50 kg subject). This will be immediately followed by a saline "chaser" from 20 to 40 ml at ~2 ml/s (20 seconds) to maximize dynamic enhancement.




Primary Outcome Measures :
  1. Breast lesions [ Time Frame: Within 4 weeks after the imaging acquisition if finished if there is a suspicious finding in the images. ]
    The existence of lesions in the breast



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)


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): NCT03354611


Contacts
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Contact: Avice O'Connell, MD 585-487-3308 avice_oconnell@urmc.rochester.edu
Contact: JoAnne McNamara 585-275-8849 JoAnne_McNamara@URMC.Rochester.edu

Locations
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United States, New York
UR Medicine Breast Imaging Recruiting
Rochester, New York, United States, 14623
Contact: Avice O'Connell, MD    585-487-3308    avice_oconnell@urmc.rochester.edu   
Contact: JoAnne McNamara    585-275-8849    JoAnne_McNamara@URMC.Rochester.edu   
Principal Investigator: Avice O'Connell, MD         
Sponsors and Collaborators
Koning Corporation
  Study Documents (Full-Text)

Documents provided by Koning Corporation:
Study Protocol  [PDF] November 21, 2017

Publications:

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Responsible Party: Koning Corporation
ClinicalTrials.gov Identifier: NCT03354611    
Other Study ID Numbers: 16-01
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No