Contrast-Enhanced Cone Beam Breast CT for Diagnostic Breast Imaging

NCT03354611 | Terminated Phase 2 FDA Device

• 1 other identifier: 16-01
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Breast lesions

  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.

Study Arms (1)

Diagnostic Workup

EXPERIMENTAL

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; Drug: Contrast Dye, Iodinated

Interventions

Contrast Enhanced Cone Beam Breast CT Scan RADIATION

* 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)

Diagnostic Workup

Contrast Dye, Iodinated DRUG

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.

Diagnostic Workup

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Koning Corporation: lead

Study Sites (2)

UR Medicine Breast Imaging

Rochester, New York, 14623, United States

Location

Knoxville Comprehensive Breast Center

Knoxville, Tennessee, 37909, United States

Location

Related Publications (12)

• 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.

  PMID: 20651210 BACKGROUND

• 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.

  PMID: 16163140 BACKGROUND

• 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.

  PMID: 10458224 BACKGROUND

• 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.

  PMID: 11425968 BACKGROUND

• 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.

  PMID: 12927667 BACKGROUND

• 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.

  PMID: 25742194 BACKGROUND

• 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.

  PMID: 20720067 BACKGROUND

• 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.

  PMID: 24934253 BACKGROUND

• 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.

  PMID: 22439131 BACKGROUND

• 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.

  PMID: 25199995 BACKGROUND

• 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.

  PMID: 20374484 BACKGROUND

• 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.

  PMID: 7480749 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: November 28, 2017
• Study Start: September 10, 2018
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: March 16, 2023

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)