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Breast CancerPhase 2/3NCT03354611

Contrast-Enhanced Cone Beam Breast CT for Diagnostic Breast Imaging

A Phase 2/3 study testing Contrast Enhanced Cone Beam Breast CT Scan and Contrast Dye, Iodinated in people with Breast Cancer, run by Koning Corporation at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Contrast Enhanced Cone Beam Breast CT Scan and Contrast Dye, Iodinated
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
2 sitesUnited States
Study dates
10 Sep 2018to 1 Sep 2021
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 34Show fewer
  • 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 locations and contacts

2 sites in 1 country.

United States2 sites

  • Knoxville Comprehensive Breast Center

    Knoxville, Tennessee, 37909

  • UR Medicine Breast Imaging

    Rochester, New York, 14623

Other trials in United States

About this study

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.

Conditions
Breast Cancer
Being tested
Contrast Enhanced Cone Beam Breast CT Scan, Contrast Dye, Iodinated
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Contrast Enhanced Cone Beam Breast CT ScanRadiation

    • 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)

  • Contrast Dye, IodinatedDrug

    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.

Study groups in NCT03354611
Study groupRoleWhat they receive
Diagnostic WorkupExperimentalThe 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.
Receives: Radiation: Contrast Enhanced Cone Beam Breast CT Scan; Drug: Contrast Dye, Iodinated

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Breast lesions

    The existence of lesions in the breast

    Measured: Within 4 weeks after the imaging acquisition if finished if there is a suspicious finding in the images.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2017
  2. Study start10 Sep 2018
  3. Primary completion1 Sep 2021
  4. Study completion1 Sep 2021

Why it stopped: The study progress doesn't meet the sponsor's requirement

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03354611
Sponsor's protocol ID
16-01
Status last verified
Feb 2021
First submitted
21 Nov 2017
Last updated
16 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • O'Connell A, Conover DL, Zhang Y, Seifert P, Logan-Young W, Lin CF, Sahler L, Ning R. Cone-beam CT for breast imaging: Radiation dose, breast coverage, and image quality. AJR Am J Roentgenol. 2010 Aug;195(2):496-509. doi: 10.2214/AJR.08.1017.

    PubMed 20651210

  • Pediconi F, Venditti F, Padula S, Roselli A, Moriconi E, Giacomelli L, Catalano C, Passariello R. CE-Magnetic Resonance Mammography for the evaluation of the contralateral breast in patients with diagnosed breast cancer. Radiol Med. 2005 Jul-Aug;110(1-2):61-8. English, Italian.

    PubMed 16163140

  • Esserman L, Hylton N, Yassa L, Barclay J, Frankel S, Sickles E. Utility of magnetic resonance imaging in the management of breast cancer: evidence for improved preoperative staging. J Clin Oncol. 1999 Jan;17(1):110-9. doi: 10.1200/JCO.1999.17.1.110.

    PubMed 10458224

  • Orel SG, Schnall MD. MR imaging of the breast for the detection, diagnosis, and staging of breast cancer. Radiology. 2001 Jul;220(1):13-30. doi: 10.1148/radiology.220.1.r01jl3113.

    PubMed 11425968

  • Gulsun M, Demirkazik FB, Ariyurek M. Evaluation of breast microcalcifications according to Breast Imaging Reporting and Data System criteria and Le Gal's classification. Eur J Radiol. 2003 Sep;47(3):227-31. doi: 10.1016/s0720-048x(02)00181-x.

    PubMed 12927667

  • McDonald RJ, McDonald JS, Kallmes DF, Jentoft ME, Murray DL, Thielen KR, Williamson EE, Eckel LJ. Intracranial Gadolinium Deposition after Contrast-enhanced MR Imaging. Radiology. 2015 Jun;275(3):772-82. doi: 10.1148/radiol.15150025. Epub 2015 Mar 5.

    PubMed 25742194

  • Prionas ND, Lindfors KK, Ray S, Huang SY, Beckett LA, Monsky WL, Boone JM. Contrast-enhanced dedicated breast CT: initial clinical experience. Radiology. 2010 Sep;256(3):714-23. doi: 10.1148/radiol.10092311.

    PubMed 20720067

  • Seifert P, Conover D, Zhang Y, Morgan R, Arieno A, Destounis S, Somerville P, Murphy PF. Evaluation of malignant breast lesions in the diagnostic setting with cone beam breast computed tomography (Breast CT): feasibility study. Breast J. 2014 Jul-Aug;20(4):364-74. doi: 10.1111/tbj.12285. Epub 2014 Jun 17.

    PubMed 24934253

  • O'Connell AM, Kawakyu-O'Connor D. Dedicated Cone-beam Breast Computed Tomography and Diagnostic Mammography: Comparison of Radiation Dose, Patient Comfort, And Qualitative Review of Imaging Findings in BI-RADS 4 and 5 Lesions. J Clin Imaging Sci. 2012;2:7. doi: 10.4103/2156-7514.93274. Epub 2012 Feb 25.

    PubMed 22439131

  • O'Connell AM, Karellas A, Vedantham S. The potential role of dedicated 3D breast CT as a diagnostic tool: review and early clinical examples. Breast J. 2014 Nov-Dec;20(6):592-605. doi: 10.1111/tbj.12327. Epub 2014 Sep 8.

    PubMed 25199995

  • Fukumura D, Duda DG, Munn LL, Jain RK. Tumor microvasculature and microenvironment: novel insights through intravital imaging in pre-clinical models. Microcirculation. 2010 Apr;17(3):206-25. doi: 10.1111/j.1549-8719.2010.00029.x.

    PubMed 20374484

  • Boetes C, Mus RD, Holland R, Barentsz JO, Strijk SP, Wobbes T, Hendriks JH, Ruys SH. Breast tumors: comparative accuracy of MR imaging relative to mammography and US for demonstrating extent. Radiology. 1995 Dec;197(3):743-7. doi: 10.1148/radiology.197.3.7480749.

    PubMed 7480749

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Contrast Enhanced Cone Beam Breast CT Scan and Contrast Dye, Iodinated in people with Breast Cancer, run by Koning Corporation at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The study progress doesn't meet the sponsor's requirement). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Breast lesions (time frame: Within 4 weeks after the imaging acquisition if finished if there is a suspicious finding in the images.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03354611, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.

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