小児がんの病期分類のための無放射線全身磁気共鳴 (MR) イメージング技術の開発
小児がんの病期分類のための無放射線全身 MR イメージング技術の開発。
A research study on the diagnosis of spread of disease for children who have been diagnosed with solid tumors using a new whole body imaging technique and a new MR contrast agent (ferumoxytol). Standard tests that are used to determine the extent and possible spread of a child's disease include magnetic resonance (MR) imaging, computed tomography (CT), Positron Emission Tomography (PET) as well as bone scanning, and metaiodobenzylguanidine (MIBG) scanning. The purpose of this study is to determine if newer imaging tests referred to as whole body diffusion-weighted MR and whole body PET/MR can detect the extent and spread of the disease as accurately or even better as the standard tests (CT, MR and/or PET/CT). The advantage of the new imaging test is that it is associated with no or significantly reduced radiation exposure compared to standard CT and PET/CT imaging tests. The results of whole body MR and PET/MR will be compared with that of the conventional, standard imaging studies for tumor detecting.
調査の概要
詳細な説明
Primary Objective: To compare the sensitivity, specificity and accuracy of WB-DW-MR scans (new technique) with 18F- FDG PET or 18F- FDG PET/CT or 18F- FDG PET/MR scans.
研究の種類
入学 (実際)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
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California
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Stanford、California、アメリカ、94305
- Stanford University Cancer Institute
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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:
- Diagnosis of a solid extra-cranial tumor like malignant lymphoma or malignant sarcoma and
- Scheduled for or completed a 18F-FDG-PET or 18F-FDG-PET/CT tumor staging procedure.
- There will be no restrictions on prior treatment.
- Very young children who need sedation or anesthesia will be excluded from the study.
- In this pediatric & adult study, the participant or parent/guardian is consented, and the patient when a minor is given an assent form and involved in the discussion as appropriate.
Exclusion Criteria:
- MR-incompatible metal implants,
- need of sedation or claustrophobia.
- Hemosiderosis/hemochromatosis (patients can still be included in 2nd branch without ferumoxytol)
- There will be restrictions regarding use of other Investigational Agents: Pt with iron-overload will not receive Ferumoxytol
- History of allergic reactions to similar compounds will be obtained and patients with a positive history of allergic reaction to iron compounds or other severe allergic reactions.will be excluded from the study.
- Pregnant women and fetuses.
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 |
|---|---|
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実験的：WB-DW-MR scan
simultaneous WB-DW-MR scan and 18-F FDG PET scan |
他の名前：
他の名前：
WB-DW-MR scans will be obtained on a 3T PET-MR system
他の名前：
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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 |
|---|---|---|
|
Area Under the Receiver Operating Characteristic Curve (ROC) of Maximum Standard Uptake Value (SUV)
時間枠：Baseline (day of scan), and 3 to 14 weeks post treatment (interval determined by tumor type and treatment protocol)
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Clinical response prediction according to maximum Standard Uptake Value (SUV), assessed using receiver operating characteristic (ROC) curve analysis. Higher AUC values indicate better discrimination between responders and non-responders. |
Baseline (day of scan), and 3 to 14 weeks post treatment (interval determined by tumor type and treatment protocol)
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Area Under the Receiver Operating Characteristic Curve (ROC) of Minimum Apparent Diffusion Coefficient (ADC)
時間枠：Baseline (day of scan), and 3 to 14 weeks post treatment (interval determined by tumor type and treatment protocol)
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Clinical response prediction according to minimum Apparent Diffusion Coefficient (ADC) values, assessed using receiver operating characteristic (ROC) curve analysis. The area under the ROC curve (AUC) measures the ability of minimum ADC values to distinguish responders from non-responders, with higher AUC values indicating better predictive performance. |
Baseline (day of scan), and 3 to 14 weeks post treatment (interval determined by tumor type and treatment protocol)
|
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Sensitivity and Specificity of WB-DW-MR Compared to 18F-FDG PET/CT
時間枠：3 to 14 weeks post-treatment (interval determined by tumor type and treatment protocol)
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Comparison of the sensitivity (true positive rate) and specificity (true negative rate) of WB-DW-MR scans versus standard 18F-FDG PET/CT scans for tumor detection and clinical response assessment, using imaging findings compared with the clinical reference standard (biopsy and/or follow-up imaging). |
3 to 14 weeks post-treatment (interval determined by tumor type and treatment protocol)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Signal-to-Noise Ratio as a Measure of Technical Optimization of Whole-Body Diffusion-Weighted MRI (WB-DW-MRI)
時間枠：Baseline (day of scan)
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Signal-to-noise ratio (SNR) was assessed to evaluate and optimize pulse sequence parameters and b-values for whole-body diffusion-weighted MRI. SNR was calculated from signal intensity measurements obtained from bone marrow metastases and normal bone marrow regions on diffusion-weighted MRI images. b50 images provide higher signal-to-noise ratio and visualization of tissue perfusion/anatomy, while b800 images emphasize restricted diffusion associated with malignancy and suppress background tissue signal. |
Baseline (day of scan)
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Heike Daldrup-Link、Stanford University
出版物と役立つリンク
一般刊行物
- Theruvath AJ, Siedek F, Yerneni K, Muehe AM, Spunt SL, Pribnow A, Moseley M, Lu Y, Zhao Q, Gulaka P, Chaudhari A, Daldrup-Link HE. Validation of Deep Learning-based Augmentation for Reduced 18F-FDG Dose for PET/MRI in Children and Young Adults with Lymphoma. Radiol Artif Intell. 2021 Oct 6;3(6):e200232. doi: 10.1148/ryai.2021200232. eCollection 2021 Nov.
- Theruvath AJ, Siedek F, Muehe AM, Garcia-Diaz J, Kirchner J, Martin O, Link MP, Spunt S, Pribnow A, Rosenberg J, Herrmann K, Gatidis S, Schafer JF, Moseley M, Umutlu L, Daldrup-Link HE. Therapy Response Assessment of Pediatric Tumors with Whole-Body Diffusion-weighted MRI and FDG PET/MRI. Radiology. 2020 Jul;296(1):143-151. doi: 10.1148/radiol.2020192508. Epub 2020 May 5.
- Klenk C, Gawande R, Uslu L, Khurana A, Qiu D, Quon A, Donig J, Rosenberg J, Luna-Fineman S, Moseley M, Daldrup-Link HE. Ionising radiation-free whole-body MRI versus (18)F-fluorodeoxyglucose PET/CT scans for children and young adults with cancer: a prospective, non-randomised, single-centre study. Lancet Oncol. 2014 Mar;15(3):275-85. doi: 10.1016/S1470-2045(14)70021-X. Epub 2014 Feb 19.
- Rashidi A, Baratto L, Theruvath AJ, Greene EB, Jayapal P, Hawk KE, Lu R, Seekins J, Spunt SL, Pribnow A, Daldrup-Link HE. Improved Detection of Bone Metastases in Children and Young Adults with Ferumoxytol-enhanced MRI. Radiol Imaging Cancer. 2023 Mar;5(2):e220080. doi: 10.1148/rycan.220080.
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 (推定)
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
本研究に関する用語
その他の研究ID番号
- IRB-20221
- NCI-2012-015321 (その他の識別子：National Cancer Institute: Clinical Trials Reporting Program)
- 1R01CA269231-01A1 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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