Contrast-Enhanced Cone Beam Breast CT for Diagnostic Breast Imaging
NCT ID: NCT03354611
Last Updated: 2023-03-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2/PHASE3
21 participants
INTERVENTIONAL
2018-09-10
2021-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
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)
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.
Interventions
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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)
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
* Patient's body weight is over the limit of the scanner table (440 lbs or 200kg)
35 Years
FEMALE
No
Sponsors
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Koning Corporation
INDUSTRY
Responsible Party
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Locations
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UR Medicine Breast Imaging
Rochester, New York, United States
Knoxville Comprehensive Breast Center
Knoxville, Tennessee, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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16-01
Identifier Type: -
Identifier Source: org_study_id
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