症候性多発性骨髄腫患者の初期評価および最終治療のための PET 18F-フルダラビンの評価 (Myelofludate)
自家骨髄移植の候補ではない、治療の第一選択である症候性多発性骨髄腫患者の初期評価および最終治療評価のための 18F-フルダラビンに対する PET の関心を評価する探索的研究
The objective of this exploratory study is to evaluate, for the first time, the sensitivity of 18F-Fludarabine to the initial diagnosis of MM compared to FDG-PET and MRI. The interest of this molecule will also be investigated as part of the end-of-treatment therapeutic evaluation.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 1
連絡先と場所
研究連絡先
- 名前：Caroline Bodet-Milin, MD
- 電話番号：33240084136
- メール：caroline.milin@chu-nantes.fr
研究場所
-
-
-
Angers、フランス、49100
- 募集
- CHU d'Angers
-
コンタクト：
- Pacôme Fosse, MD
-
主任研究者：
- Pacôme Fosse, MD
-
Brest、フランス、29000
- 募集
- CHU de Brest
-
コンタクト：
- Pierre Yves Salaün, MD
-
主任研究者：
- Pierre Yvese Salaün, MD
-
Caen、フランス、14000
- 募集
- CHU de Caen
-
コンタクト：
- Nicolas Aide, MD
-
主任研究者：
- Nicolas Aide, MD
-
Nantes、フランス、44093
- 募集
- CHU de Nantes
-
コンタクト：
- Caroline Bodet-Milin, MD
-
主任研究者：
- Caroline bodet Milin, MD
-
Rennes、フランス、35000
- 引きこもった
- Centre Eugène Marquis
-
Rennes、フランス、35000
- 引きこもった
- CHU de Rennes
-
Tours、フランス、37000
- 募集
- CHU de Tours
-
コンタクト：
- Maria Joao Santiago-Ribeiro, MD
-
主任研究者：
- Maria Joao Santiago-Ribeiro, MD
-
-
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:
- Symptomatic MM in the first line in patients who are not candidates for autologous bone marrow transplantation.
- Patients eligible for one of the treatments considered as standard in a patient who is not eligible for autograft, according to ESMO's European recommendations
- MM with measurable disease either by the serum evaluation of the monoclonal component or by the determination of free light chains (serum or urinary).
- Patient affiliated with a social insurance scheme
- The patient must understand and voluntarily sign the informed consent form
- Women of childbearing potential must have a serum pregnancy test (performed within 2 days before each PET scan.)
- Women of childbearing potential must use an effective contraceptive method throughout the course of the study and for 30 days after the last PET.
- Male patients (vasectomised or not) with a pregnant partner or a partner of childbearing potential must use a condom and a spermicide until 90 days after the last PET.
- HIV serology known to be negative
- Karnofsky ≥ 70 or ECOG 0-1
Exclusion Criteria:
- Age under 18 years
- Pregnancy or breastfeeding
- Male or female refusing birth control conditions
- Primary AL amyloidosis and myeloma complicated by amyloidosis
- Neutropenia <1000 PN / mm3
- Thrombocytopenia <70,000 / mm3
- Hepatic impairment: bilirubin> 35μmol / L and SGOT, SGPT, alkaline phosphatase greater than 3 N
- Renal impairment defined by creatinine clearance <50 ml / min
- History of other malignancies with the exception of basal cell carcinoma and stage I cervical cancer
- Severe active infection
- Active infection with known hepatitis B or C virus.
- Patient with insulin-dependent or non-insulin-dependent diabetes mellitus.
- Intolerance or known allergy to any of the study drugs or any of its analogues
- Psychiatric illness that may interfere with participation in the study
- Patient under safeguard of justice
- Intellectual inability to sign informed consent
- Persons protected by law
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：Fludatep
PET with 18F-Fludarabine |
Two PET with 18F-Fludarabine : one at Baseline, the second one at the end of treatment of myeloma |
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 |
|---|---|---|
|
Detection of sensitivity of the lesions (osseous and extra-osseous) of 18Fludarabine PET (FludaTEP)
時間枠：Before treatment
|
The sensitivity of the initial FludaTEP will be evaluated using an optimal reading mode lesion analysis (ie by consensus of experts) by defining : True positive:
False negative: -negative lesion with 18F-Fludarabine and positive FDG-PET and / or MR Lesions positivity in PET-FDG and MRI will be assessed by central reading done by consensus of experts. Lesions positivity with 18F-Fludarabine will be defined by central reading assessed by 2 nuclear physicians experts in hematology with no access to the other exams' results. |
Before treatment
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
To evaluate the specificity and the positive and negative predictive values of the FludaTEP for the initial assessment through an optimal reading mode.
時間枠：Before treatment
|
The specificity, positive predictive value (PPV) and negative predictive value (NPV) of the FludaTEP for the initial assessment will be assessed through an optimal reading mode lesion analysis (ie by consensus of experts) using same true positive and false positive définitions as for the main endpoint and defining: -positive lesion with 18F-Fludarabine but not found or confirmed on an histological examination, or other imaging technique (PET-FDG, MRI +/- Scan) or at follow-up True negative: -negative lesion with 18F-Fludarabine and negative with FDG-PET and MRI |
Before treatment
|
|
To evaluate the sensitivity, specificity, and positive and negative predictive values of the FludaTEP for the initial balance according to the local reading
時間枠：Before treatment
|
The specificity, positive predictive value (PPV) and negative predictive value (NPV) of the FludaTEP for the initial balance will be evaluated through lesion analysis based on the local reading investigator center reading using definitions of VP, VN, FP, and FN described above. |
Before treatment
|
|
To evaluate the prognostic impact of FDG-PET and FludaTEP on the number of lesions detected by each imaging technique in a population of MM patients in the 1st line therapeutic but not candidates for marrow autograft.
時間枠：After treatment
|
The prognostic impact of FDG-PET and FludaTEP as a function of the number of lesions detected by each imaging technique will be evaluated by evaluating the impact of these data on progression-free survival and overall survival. Progression-free survival is defined as the time between the beginning of treatment of the disease and relapse or progression. Overall survival is defined as the time between the start of treatment and death. |
After treatment
|
|
To evaluate the prognostic impact of FludaTEP on the initial assessment and for the end-of-treatment therapeutic evaluation
時間枠：Before and After treatment
|
The prognostic impact of FludaTEP on the initial assessment and for the end-of-treatment therapeutic evaluation will be determined by evaluating the impact of a decrease and a negation of the signal in imaging on an increase in progression-free survival and overall survival. |
Before and After treatment
|
|
Evaluate in a population of MM patients the existence of a correlation between the 18Fludarabine and FDG uptake intensities
時間枠：Before and After treatment
|
Correlations between the 18Fludarabine and FDG uptake intensities assessed by SUVs and the quantitative expression of markers measured in flow cytometry and cytogenetic data (in particular the expression of the coding gene for hexokinases) will be measured using Spearman's correlation coefficient. |
Before and After treatment
|
|
Evaluate in a population of MM patients the existence of a correlation between the 18Fludarabine and FDG uptake intensities and the cytogenetic data Tolerance to 18F-Fludarabine
時間枠：Before and After treatment
|
Tolerance to 18F-Fludarabine will be evaluated by clinical monitoring during 2 hours following the 18F-Fludarabine injection. Clinical data will be taken prior to the 18F-Fludarabine injection, prior to the data capture at 60min and after the last data capture. |
Before and After treatment
|
協力者と研究者
協力者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
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
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