[68Ga]Ga -PentixaFor-PET の第一選択治療における多発性骨髄腫の初期病期診断と治療評価との関連性 (PentiMyelo)
[68Ga]Ga -PentixaFor の関連性を評価する探索的研究は、第一選択治療における症候性多発性骨髄腫患者の初期病期分類および治療評価
The aim of our study is to confirm the relevance of PET using [68Ga]Ga -PentixaFor ligand, in comparison with FDG, for initial staging and therapeutic evaluation of symptomatic multiple myeloma patients in first line treatment or in relapse. The prognostic value of positive CXCR4 expression will also be assessed and [68Ga]Ga -PentixaFor/FDG discordances explored.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究場所
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-
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Bordeaux、フランス
- CHU Bordeaux
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Nantes、フランス
- Nantes UH
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Paris、フランス
- APHP - Site Tenon
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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
説明
Inclusion Criteria:
- Age ≥ 18 years
- Symptomatic MM patients according to IMWG criteria (12) requiring first-line treatment
- Written and signed informed consent (obtained on the screening day at the latest and before any investigation)
- ECOG (Eastern Cooperative Oncology Group) < 2
- Patient affiliated to or beneficiary of the National Health Service
Exclusion Criteria:
- HIV positive, active Hepatitis B or C
- Childbearing or child breast feeding women
- Women or men without effective contraceptive barrier if needed
- eGFR < 50 ml/min by MDRD or CKDEPI
- Previous or concurrent second malignancy except for adequately treated basal cell carcinoma of the skin, curatively treated in situ carcinoma of the cervix, curatively treated solid cancer, with no evidence of disease for at least 2 years
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Known active infection
- Patient with uncontrolled insulin-dependent or non-insulin-dependent diabetes mellitus
- Patient under guardianship or trusteeship
- Patient under judicial protection
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：[68Ga]ガペンティアフォー
|
Tomography by emission of positons (PET) with theradiopharmaceutic [68Ga]Ga-PentixaFor |
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 |
|---|---|---|
|
To determine the sensitivity of [68Ga]Ga-PentixaFor-PET to detect Multiple Myeloma (MM) lesions [Bone marrow (BM) lesions and/or extra-medullary disease (EMD) ] at the time of initial diagnosis or at relapse.
時間枠：1 Month
|
Sensitivity will be assessed by patient and lesion analysis by defining:
|
1 Month
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
To determine at the time of initial diagnosis or at relapse, the specificity, the positive predictive value (PPV) and negative predictive value (NPV) of [68Ga]Ga-PentixaFor-PET
時間枠：1 Month
|
The specificity (PPV and NPV) of [68Ga]Ga-PentixaFor-PET at the time of initial diagnosis will be assessed by patient and lesion analysis using the same definitions of TP and FN as for the primary objective. |
1 Month
|
|
To determine at the time of initial diagnosis or at relapse, the prognostic impact of FDG PET and of [68Ga]Ga-PentixaFor-PET depending on the positivity, number and intensity of uptake detected by each imaging technique
時間枠：1 Month
|
The prognostic impact of PET-FDG and [68Ga]Ga-PentixaFor-PET based on the number of lesions detected and their intensity of uptake by each imaging technique will be evaluated by assessing the impact of these data on the PFS and OS. PFS is defined as the time from the start of treatment to relapse or progression. OS is defined as the time from the start of first treatment to death. |
1 Month
|
|
To determine at the time of initial diagnosis or at relapse, the discrepancies rate between FDG PET and [68Ga]Ga-PentixaFor-PET
時間枠：1 Month
|
Investigators will consider as discordant a lesion positive by FDG PET but negative by [68Ga]Ga-PentixaFor-PET and/or a lesion negative by FDG PET but positive by [68Ga]Ga-PentixaFor-PET |
1 Month
|
|
To determine at the time of initial diagnosis or at relapse, the factors associated with discrepancies between FDG PET and [68Ga]Ga-PentixaFor-PET
時間枠：1 Month
|
Investigators will consider as discordant a lesion positive by FDG PET but negative by [68Ga]Ga-PentixaFor-PET and/or a lesion negative by FDG PET but positive by [68Ga]Ga-PentixaFor-PET |
1 Month
|
|
To determine at the initial diagnosis or relapse, the correlation between PET-FDG and [68Ga]Ga-PentixaFor-PET uptakes evaluated by SUV and the cytogenetic data evaluated on the myelogram (particularly the measurement of the expression of the gene coding
時間枠：1 Month
|
68Ga]Ga -PentixaFor and FDG uptakes assessed by SUV and the quantitative expression of biological markers on myelogram (including expression of the gene coding for hexokinases). |
1 Month
|
|
To determine at the time of initial diagnosis or at relapse, the tolerance of [68Ga]Ga-PentixaFor-PET
時間枠：1 Month
|
Tolerance of [68Ga]Ga-PentixaFor will be assessed by clinical monitoring of the patient for 1 hour after [68Ga]Ga-PentixaFor injection. Clinical data (heart rate, respiratory rate and blood pressure) will be collected prior [68Ga]Ga -PentixaFor injection before acquisition (at 60 min) |
1 Month
|
|
To determine at the time of initial diagnosis or at relapse, the tolerance of [68Ga]Ga-PentixaFor-PET
時間枠：1 Month
|
Tolerance of [68Ga]Ga-PentixaFor will be assessed by clinical monitoring of the patientat the end of acquisition (at approximately 80 min). |
1 Month
|
|
To determine at the time of therapeutic evaluation the discrepancies rate between FDG PET and [68Ga]Ga-PentixaFor-PET and if available their link with histology.
時間枠：100 Day or 6 Month
|
Investigators will consider as discordant a lesion positive by FDG PET but negative by [68Ga]Ga-PentixaFor-PET and/or a lesion negative by FDG PET but positive by [68Ga]Ga-PentixaFor-PET |
100 Day or 6 Month
|
|
To determine at the time of therapeutic evaluation the prognostic impact of FDG PET and [68Ga]Ga-PentixaFor-PET depending on the positivity, number and intensity of uptake detected by each imaging technique.
時間枠：100 Day and 6 Month
|
The prognostic impact of [68Ga]Ga-PentixaFor-PET after therapy will be determined by evaluating the impact of a decrease uptake and/or a normalisation of images on PFS and OS. |
100 Day and 6 Month
|
|
To determine at the time of therapeutic evaluation the prognostic impact of FDG PET and [68Ga]Ga-PentixaFor-PET depending on the positivity, number and intensity of uptake detected by each imaging technique.
時間枠：Every 6 months after the end of treatment
|
The prognostic impact of [68Ga]Ga-PentixaFor-PET after therapy will be determined by evaluating the impact of a decrease uptake and/or a normalisation of images on PFS and OS. |
Every 6 months after the end of treatment
|
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To determine at the time of therapeutic evaluation the link between PET-FDG, [68Ga]Ga-PentixaFor-PET results and minimal residual disease evaluated by flow cytometry
時間枠：100 Day or 6 Month
|
PET-FDG, [68Ga]Ga-PentixaFor-PET results (positive/negative) and minimal residual disease evaluated by flow cytometry (positive/negative). |
100 Day or 6 Month
|
|
To determine at the time of therapeutic evaluation the tolerance of [68Ga]Ga-PentixaFor-PET
時間枠：100 Day or 6 Month
|
Tolerance of [68Ga]Ga-PentixaFor will be assessed by clinical monitoring of the patient for 1 hour after [68Ga]Ga -PentixaFor injection. Clinical data (heart rate, respiratory rate and blood pressure) will be collected prior [68Ga]Ga-PentixaFor injection before acquisition (at 60 min) and at the end of acquisition (at approximately 80 min). |
100 Day or 6 Month
|
協力者と研究者
出版物と役立つリンク
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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