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治験 NCT06122610（対象：神経内分泌腫瘍、ソマトスタチン受容体陽性神経内分泌腫瘍）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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ウィスコンシン大学マディソン校Using Novel Imaging to More Safely Treat Neuroendocrine Tumors
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます！「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT06122610 は 神経内分泌腫瘍、ソマトスタチン受容体陽性神経内分泌腫瘍 に関する 治療 の研究で、第I相・第一段階 介入研究 臨床試験 です。現在は 募集中 で、2025年3月7日 から開始しています。10 名の参加者 の募集が計画されています。この治験は ウィスコンシン大学マディソン校 によって主催され、2026年2月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年5月13日 です。
概要
The goal of this research is to determine if DetectnetTM PET/CT can be used to make Lutathera therapy safer for patients with neuroendocrine cancer.
Participants will:
- Complete two phases involving 6 visits
- Undergo additional research PET/CT, and possibly SPECT/CT scans
詳細説明
The goal of this research study is to determine if DetectnetTM PET/CT scanning over several days can be used to deliver Lutathera in a safer manner.
In this research, participants will be asked to complete a screening phase and possibly a dosimetry phase. The screening phase will require 2 visits. The dosimetry phase will also require 3 research visits.
公式タイトル
Dosimetry-Guided 177Lu-DOTATATE Treatment Planning Using 64Cu-DOTATATE as a Surrogate
疾患／病気
神経内分泌腫瘍ソマトスタチン受容体陽性神経内分泌腫瘍その他の研究識別子
- 2023-0121
- Protocol Version 3/24/2025 (その他の識別子) (UW Madison)
- SMPH/RADIOLOGY/RADIOLOGY (その他の識別子) (UW Madison)
NCT番号
開始日
2025-03-07
最終更新日
2025-05-13
終了予定日
2026-02
目標参加者数
10
試験の種類
介入研究
治験の相・段階
第I相・第一段階
状況
募集中
キーワード
neuroendocrine tumors
主目的
治療
割付方法
該当なし
介入モデル
単一群割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Participants treated with Lutathera | Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT) SPECT/CT will be performed after first cycle of Lutathera® treatment Photon Emission Tomography / CT (PET/CT) PET/CT will be performed after 64Cu-DOTATATE and Lutathera® treatment 64Cu-Dotatate Standard of care administration of radioactive drug for PET/CT 177Lu-Dotatate Standard of care administration of radioactive drug for PET/CT and SPECT/CT |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Compare pre-therapy and post-therapy voxel-based dosimetry estimates | Absorbed doses to organs will be estimated using radiation dosimetry methods based on both multi-timepoint PET and multi-timepoint SPECT imaging. Mean dose estimates in units of Gy to the index tumor(s) and dose limiting organs (kidneys and bone marrow) will be compared between PET-based dosimetry and SPECT-based dosimetry. Using SPECT-based dosimetry as the gold standard truth, Bland-Altman analysis will be performed for each organ/tumor to compare PET-based dose estimates to SPECT-based estimates. Mean bias and 95% confidence intervals will be calculated. | Baseline and 120 hours post-dose |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Absorbed radiation doses | Absorbed radiation doses from 177Lu-DOTATATE in organs will be summarized with descriptive statistics. | 1 hour post-dose, 4 hours post-dose, 48 hours post-dose, 120 hours post-dose |
Absorbed radiation doses of 64Cu-DOTATATE | Absorbed radiation doses of 177Lu-DOTATATE in organs using 64Cu-DOTATATE as an imagining surrogate will be summarized with descriptive statistics. | 1 hour post-dose, 4 hours post-dose, 48 hours post-dose, 120 hours post-dose |
Compare 3D voxel-based versus model based dosimetry in participants receiving 177Lu_DOTATATE | Absorbed doses to organs will be estimated using radiation dosimetry methods based on multi-timepoint SPECT imaging. Mean dose estimates in units of Gy to the index tumor(s) and dose limiting organs (kidneys and bone marrow) will be compared between 3D voxel-based and model-based dosimetry methods. Using 3D voxel-based dosimetry as the gold standard truth, Bland-Altman analysis will be performed for each organ/tumor to compare 3D voxel-based to model-based methods. Mean bias and 95% confidence intervals will be calculated. | Baseline and 120 hours post-dose |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- Candidates for 177Lu-DOTATATE (Lutathera) treatment for somatostatin receptor-positive neuroendocrine tumor
- Unable to lie flat during or tolerate PET/CT or SPECT/CT
- Known incompatibility to CT. SPECT, or PET scans
- Unlikely to comply with study procedures, restrictions and requirements and judged by the investigator that the participant is not suitable for participation in the study
ウィスコンシン大学マディソン校247 件のアクティブな治験を探索試験中央連絡先
連絡先: Radiology Studies, 608-282-8349, [email protected]
1 1カ国の場所
Wisconsin
University of Wisconsin - Madison, Madison, Wisconsin, 53705, United States
募集中