Cone Beam CT for Breast Imaging
Cone Beam CT for Breast Imaging: A Pilot Study
調査の概要
状態
研究の種類
入学 (実際)
連絡先と場所
研究場所
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New York
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Rochester、New York、アメリカ、14620
- University of Rochester Highland Breast Imaging Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
In Group I, up to 100 women, at least 40 years of age, who have had a routine standard mammogram read as BI-RADS® 0, 1, 2, or 3 will also undergo 3D breast imaging using a cone beam CT scanner specifically designed to image the breast.
Group II includes forty (40) women, who have had abnormalities detected by physical exam or an imaging modality and are also scheduled for breast biopsy of the index lesion, will also undergo a CBCT of the breast(s), prior to biopsy.
説明
Normal Group:
Inclusion Criteria:
- Are at least 40 years of age of any ethnicity
- Had a routine mammogram, read as BI-RADS® 0, 1, 2 or 3
- Will undergo study imaging no later than six months from date of routine mammogram.
- Is able to undergo informed consent.
Exclusion Criteria:
- Pregnancy
- Lactation
- Patients 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.
- Patients who are unable to tolerate study constraints.
Patients who have received radiation treatments to the thorax 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
- Patients who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.
Patients who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to)
- Tuberculosis
- Severe scoliosis
Diagnostic Group:
Inclusion Criteria:
- Women who are at least 40 years of age of any ethnicity
- Have a palpable abnormality detected by Breast Self Exam (BSE), or Clinical Breast Exam (CBE) or have a non-palpable abnormality detected by an imaging modality
- After diagnostic work-up are categorized as BI-RADS® 4 or 5.
- Are scheduled for biopsy either by large gauge needle biopsy or excisional biopsy.
- Will undergo study imaging prior to biopsy and within four weeks of diagnostic work-up.
Exclusion Criteria:
- Pregnancy
- Lactation
- Patients who have already undergone biopsy for the index lesion
- Patients who are unable or unwilling to undergo biopsy for the lesion of concern
- Patients with physical limitations that may prohibit the patient from resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker.
- Patients who are unable to tolerate study constraints.
Patients 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
- Patients who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.
Patients who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to)
- Tuberculosis
- Severe scoliosis
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
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Normal Group
In Group I, up to 100 women, at least 40 years of age, who have had a routine standard mammogram read as BI-RADS® 0, 1, 2, or 3 will also undergo 3D breast imaging using a cone beam CT scanner specifically designed to image the breast.
Of these 100, we hope to enroll at least 30 subjects with mammograms read as BI-RADS® 0 and at least 30 read as BI-RADS® 3. The BI-RADS® 0 category refers to patients for whom additional imaging is required after a screening mammogram provided incomplete diagnostic information.
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Diagnostic Group
The goals of Group II will be to compare the CBCT study with standard imaging for the diagnosis of breast disease in palpable or non-palpable breast lesions (having a BI-RADS® score of 4 or 5).
Forty (40) women, who have had abnormalities detected by physical exam or an imaging modality and are also scheduled for breast biopsy of the index lesion, will also undergo a CBCT of the breast(s), prior to biopsy.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Image Quality of Cone Beam Breast CT
時間枠:6 years
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This study was to evaluate the radiation dose, breast coverage, and image quality of cone-beam breast CT compared with a conventional mammographic examination.
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6 years
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協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- 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.
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- URMC-001
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
乳がんの臨床試験
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