Early On-therapy PET at First-line Treatment in Diffuse Large B-cell Lymphoma Stage IIB-IV
Evaluation of Response to Treatment Using 18F-FDG Positron Emission Tomography Imaging (PET) With Special Emphasize on the Prognostic Significance of Early On-therapy PET at First-line Treatment in Diffuse Large B-cell Lymphoma Stage IIB-IV
調査の概要
詳細な説明
Title: Evaluation of response to treatment using 18F-FDG positron emission tomography imaging (PET) in diffuse large B-cell lymphoma stage IIB-IV with special emphasize on the prognostic significance of early on-therapy PET at first-line treatment
Study design: Multicenter trial.
Planned sample size: 100 patients.
Number of centers: Denmark 2; Sweden 1; Norway 1; Finland 1.
Aim of the study: 1. To evaluate the prognostic significance of PET early after treatment initiation. 2. To compare early PET with standard response criteria for NHL and the International Prognostic Index (IPI) in the prediction of response and outcome.
Primary objective: The prognostic significance of FDG-PET after 1 cycle of chemotherapy.
End-points: Progression-free survival (PFS). Overall survival (OS). Response to treatment (standardized response criteria) at mid-treatment and post-treatment.
Inclusion criteria:
Age ≥ 18 years. Newly diagnosed consecutive patients with diffuse large B-cell lymphoma (DLBCL) according to the WHO classification.
Ann Arbor stage IIB-IV. Written informed consent.
Exclusion criteria: Previously treated with chemotherapy or irradiation. Previous malignant diagnosis except basal cell carcinoma and cervical carcinoma in situ.
Pregnancy. Lactation. Diabetes mellitus. Extreme adipositas. Claustrophobia. Active inflammatory disease or infection.
PET-CT evaluation: PET and CT at primary staging before initiation of therapy and PET after one cycle of intravenous chemotherapy (day 10-20) are mandatory. The results of the PET scans are blinded and will not be available for the local physicians. If the PET result is opened, the patient will be excluded from the study.
Only post-treatment PET scans are allowed outside the protocol. The local physician may use post-treatment PET in diagnostic or therapeutic considerations.
Only dedicated full-ring PET scanners are allowed in this study.
Treatment: Therapy with a CHOP-like backbone according to local standards of the individual centers. Treatment according to other protocols allowed.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Odense、デンマーク、5000
- Department of Hematology, Odense University Hospital
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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:
- Age ≥ 18 years.
- Newly diagnosed consecutive patients with diffuse large B-cell lymphoma (DLBCL) according to the WHO classification.
- Ann Arbor stage IIB-IV.
- Written informed consent.
Exclusion Criteria:
- Previously treated with chemotherapy or irradiation.
- Previous malignant diagnosis except basal cell carcinoma and cervical carcinoma in situ.
- Pregnancy.
- Lactation.
- Diabetes mellitus.
- Extreme adipositas.
- Claustrophobia.
- Active inflammatory disease or infection.
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 |
介入・治療 |
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単発グループ研究
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One extra PET scan after 1 cycle of treatment.
他の名前：
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協力者と研究者
捜査官
- 主任研究者：Lars M Pedersen, MD、Nordic Lymphoma Group (Large Cell Group)
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- NLG PET Study
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PET scanの臨床試験
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Emory UniversityNational Cancer Institute (NCI); Blue Earth Diagnostics積極的、募集していない
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Centre hospitalier de l'Université de Montréal...Allergan募集