Contrast-Enhanced Cone Beam Breast CT for Diagnostic Breast Imaging

March 14, 2023 updated by: Koning Corporation
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14623
        • UR Medicine Breast Imaging
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Knoxville Comprehensive Breast Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within 4 weeks after the imaging acquisition if finished if there is a suspicious finding in the images.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Koning Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2018

Primary Completion (Actual)

September 1, 2021

Study Completion (Actual)

September 1, 2021

Study Registration Dates

First Submitted

November 21, 2017

First Submitted That Met QC Criteria

November 25, 2017

First Posted (Actual)

November 28, 2017

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 14, 2023

Last Verified

February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 16-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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