PET-CT in the Initial Staging of Breast Cancer and in the Early Assessment of Response to Neoadjuvant Chemotherapy (ASAINT)
Role of Fluorodeoxyglucose (FDG) PET-CT in the Initial Staging of Breast Cancer (ASAINT 1) and in the Early Assessment of Response to Neoadjuvant Chemotherapy (ASAINT 2)
The two main objectives of this prospective study are:
- to identify those patients for whom pre-treatment FDG (Fluorodeoxyglucose) PET (positron emission tomography) CT-scan (Computed tomography scan) provides useful information for the treatment of breast cancer (ASAINT 1),
- to improve FDG PET-CT-scan imaging criteria for assessing response to neoadjuvant therapy early, in M0-patients (ASAINT 2).
The secondary objective is to better understand the interactions between the imaging parameters of FDG PET-CT-scan and biological and histological features of breast cancer .
This is a non-interventional study. Two PET-CT-scans are performed, one before starting treatment, and the other after 2 cycles of neoadjuvant chemotherapy. The two PET-CT-scans are prescribed by oncologists from the center of breast diseases Unit at St. Louis hospital, in Paris, France. Oncologists provide clear information to the patients on the purpose of the examination. The examinations are performed in the nuclear medicine department at St. Louis hospital. PET-CT-scans data, tumor characteristics, results of other imaging and biological tests, results of surgery and patient's follow-up are summarized in a "de-identified" file. This file has been declared to the National Commission on Informatics and Liberties (CNIL). The data in this file are established prospectively and secondary analyzed to assess the precise role of PET-CT-scans in the initial staging of breast cancer and to determine the optimal PET-CT-scans criteria to evaluate response to neoadjuvant treatment early.
調査の概要
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Paris、フランス、75010
- 募集
- Hopital Siant-louis
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コンタクト:
- David Groheux, MD-PHD
- 電話番号:+33 630603009
- メール:david.groheux@aphp.fr
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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
説明
Inclusion Criteria :
- Histologically confirmed breast cancer
- Stage II and III breast cancer
- Neo-adjuvant chemotherapy
- Baseline PET-CT-scan (ASAINT 1 and 2)
- PET-CT-scans after second cycle of neo-adjuvant chemotherapy (ASAINT 2)
- Tumor biopsy for diagnosis and biological analysis with hormone receptors and Human Epidermal Growth Factor Receptor-2 (HER2) available
- Surgical intervention after completion of neo-adjuvant chemotherapy
- Evaluable pathological response
Exclusion Criteria :
- Other tumor localization
- Non controlled diabetes mellitus
- Pregnancy
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
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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Pathological complete response in M0 patients at baseline PET (stage II-III)
時間枠:18 weeks
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Absence of residual cancer cells in the primary breast tumor and in axillary lymph nodes
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18 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of distant metastases (M1 patients at baseline PET)
時間枠:2 weeks
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Detection of distant metastases by FDG PET-CT
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2 weeks
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Number of metastatic nodes at baseline PET (axillary and extra-axillary)
時間枠:2 weeks
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Detection of metastatic axillary and extra-axillary nodes by FDG PET-CT
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2 weeks
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Standard uptake value on the FDG-PET (Fluorodeoxyglucose positron emission tomography)
時間枠:2 weeks
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2 weeks
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Patients overall survival
時間枠:5 years
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5 years
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event free survival
時間枠:5 years
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5 years
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Patients overall survival
時間枠:3 years
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3 years
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イベントフリーサバイバル
時間枠:3年
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3年
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Patients overall survival
時間枠:2 years
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2 years
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event free survival
時間枠:2 years
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2 years
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Total lesion glycolysis on the FDG-PET (Fluorodeoxyglucose positron emission tomography)
時間枠:2 weeks
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2 weeks
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Metabolic tumor volume on the FDG-PET (Fluorodeoxyglucose positron emission tomography)
時間枠:2 weeks
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2 weeks
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Tumor heterogeneity determined on the FDG-PET (Fluorodeoxyglucose positron emission tomography)
時間枠:2 weeks
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2 weeks
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協力者と研究者
捜査官
- 主任研究者:David Groheux, MD-PhD、APHP, IUH, University Paris Diderot, Paris 7, SPC
- スタディチェア:Matthieu Resche-Rigon, MD-PHD、DRCD APHP Paris
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
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
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。