Contrast Enhanced Ultrasound and Shear Wave Elastography in Measuring Response in Patients With Breast Cancer Receiving Chemotherapy Before Surgery
Real Time Contrast Enhanced Ultrasound and Ultrasound-Based Elastography: Novel Techniques in Assessment of Treatment Response to Neoadjuvant Chemotherapy for Breast Cancer
調査の概要
状態
条件
詳細な説明
PRIMARY OBJECTIVES:
I. To establish a quantitative prediction rule for accurate and early prediction of the pathologic tumor response assessed post-surgery, using the change of contrast enhanced ultrasound (CEUS) assessed tumor size and perfusion characteristics before (baseline) and 2-3 weeks following initiation of neoadjuvant chemotherapy (NAC).
II. To assess the agreement between CEUS based classification rule and pathologically determined treatment response (baseline versus pre-surgical scan).
III. To establish a quantitative prediction rule for accurate and early prediction of the pathologic tumor response assessed post-surgery, using the change in propagation velocity of a shear mechanical wave in tissue before (baseline) and 2-3 weeks following initiation of NAC.
IV. To assess the agreement between shear wave elastography (SWE) based classification rule and pathologically determined treatment response (baseline versus pre-surgical scan).
SECONDARY OBJECTIVES:
I. To explore the role of combined CEUS + SWE features obtained at early treatment phase (2-3 weeks following initiation of NAC), in accurately predicting the pathologically determined tumor response.
II. To investigate the agreement in assessment of therapy response to NAC between CEUS versus contrast enhanced magnetic resonance imaging (CE MRI) and SWE versus CE MRI for baseline versus pre-surgery scan and to identify discordant cases using scatter plot and contingency tables.
OUTLINE:
Patients undergo dynamic contrast-enhanced ultrasound imaging and shear wave elastography at baseline, 2-3 weeks after initiation of chemotherapy, and before surgery.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
-
-
California
-
Los Angeles、California、アメリカ、90033
- USC Norris Comprehensive Cancer Center
-
-
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
説明
Inclusion Criteria:
- Women with histologically confirmed breast cancer (by core needle biopsy)
- Women with >= 2 cm clinically or radiologically measureable breast cancer
- Women scheduled to receive neoadjuvant chemotherapy as part of their treatment plan
- Women competent to sign study specific written Informed Consent
- Women willing to comply with protocol requirements
Exclusion Criteria:
- Women who are pregnant
- Women who have undergone open surgical (excisional) biopsy for breast cancer diagnosis
- Women who have had a prior history of breast cancer in the same breast
- Women with known cardiac shunt, pulmonary hypertension or hypersensitivity to perflutren agent
- Women who cannot consent for themselves
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
- 主な目的:診断
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:Diagnostic (CEUS, SWE)
Patients undergo dynamic contrast-enhanced ultrasound imaging and shear wave elastography at baseline, 2-3 weeks after initiation of chemotherapy, and before surgery.
|
Undergo CEUS
他の名前:
Undergo SWE
他の名前:
Participant will receive contrast agent by intravenous administration
他の名前:
Equipment used for SWE
他の名前:
|
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 |
---|---|---|
Model predicted treatment response for CEUS and SWE
時間枠:Up to 1 year
|
Weighted Kappa will be used to assess the agreement.
|
Up to 1 year
|
Pathologically determined treatment response for CEUS and SWE
時間枠:Up to 1 year
|
Weighted Kappa will be used to assess the agreement.
|
Up to 1 year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Treatment response predicted by novel ultrasound techniques
時間枠:Up to 1 year
|
Weighted Kappa will be used to assess the agreement.
Scatter plots and contingency tables will be used to identify discordant cases between US techniques and CE MRI.
|
Up to 1 year
|
Treatment response predicted by CE MRI
時間枠:Up to 1 year
|
Weighted Kappa will be used to assess the agreement.
Scatter plots and contingency tables will be used to identify discordant cases between US techniques and CE MRI.
|
Up to 1 year
|
協力者と研究者
捜査官
- 主任研究者:Linda Hovanessian-Larsen、University of Southern California
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
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
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
-
Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital; The First Affiliated... と他の協力者完了
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); Highlight Therapeutics積極的、募集していない平滑筋肉腫 | 悪性末梢神経鞘腫瘍 | 滑膜肉腫 | 未分化多形肉腫 | 骨の未分化高悪性度多形肉腫 | 粘液線維肉腫 | II期の体幹および四肢の軟部肉腫 AJCC v8 | III期の体幹および四肢の軟部肉腫 AJCC v8 | IIIA 期の体幹および四肢の軟部肉腫 AJCC v8 | IIIB 期の体幹および四肢の軟部肉腫 AJCC v8 | 切除可能な軟部肉腫 | 多形性横紋筋肉腫 | 切除可能な脱分化型脂肪肉腫 | 切除可能な未分化多形肉腫 | 軟部組織線維肉腫 | 紡錘細胞肉腫 | ステージ I 後腹膜肉腫 AJCC (American Joint Committee on Cancer) v8 | 体幹および四肢の I 期軟部肉腫 AJCC v8 | ステージ... およびその他の条件アメリカ