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治験 NCT07203911 (SURGIO)（対象：舌癌、口腔がん、Squamous Cell Carcinoma of the Oral Cavity or Oropharynx）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。 | ||
フィルター基準に一致する試験が1件見つかりました
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Surgeon-performed Ultrasound for Real-time Guidance In Oral Cancer Surgeries - A Multicenter Randomized Controlled Trial (SURGIO) 200 無作為化
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」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 NCT07203911 (SURGIO) は 介入研究 臨床試験 で、舌癌、口腔がん、Squamous Cell Carcinoma of the Oral Cavity or Oropharynx に関するものです。現在は 募集中 で、2025年9月15日 から開始しています。200 名の参加者 の募集が計画されています。この試験は Tobias Todsen によって主導され、2031年8月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年10月2日 です。
概要
The goal of this clinical trial is to improve the surgical treatment of patients with oral cancer. We will explore whether the use of surgeon performed ultrasound during these surgeries result in better tumor removal. We hypothesize that using intraoperative ultrasound to assist the resection results in more frequent clear surgical margins in oral cancer surgeries compared to standard methods. This improvement is ass...もっと見る
詳細説明
Background:
Surgery is the primary treatment for early-stage oral cancer, aiming to completely remove the tumor along with a margin of healthy tissue to ensure a clear surgical margin. However, in up to 50% of cases, the tumor is not entirely removed, leading to higher rates of cancer recurrence and mortality. This challenge often arises from difficulty distinguishing tumor tissue from healthy tissue during the oper...
もっと見る公式タイトル
Surgeon-performed Ultrasound for Real-time Guidance In Oral Cancer Surgeries - A Multicenter Randomized Controlled Trial
疾患名
舌癌口腔がんSquamous Cell Carcinoma of the Oral Cavity or Oropharynxその他の研究識別子
- SURGIO
- p-2024-18099
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
二重盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実薬対照薬Control The patients in the control group will have surgery for oral cancer conducted following the current standards for each center. | 標準治療 Standard surgical treatment of oral cancer |
実験的Intervention In the intervention group, surgeons will have both in-vivo and ex-vivo ultrasound at to guide the resection and evaluate surgical margins during the procedure. The in-vivo ultrasound will be employed in real-time on the tumor to guide the resection process. The surgeon begins the resection, periodically pausing to obtain real-time images of the resection plane using ultrasound. This is done by repositioning the parti...もっと見る | 超音波画像 Ultrasound will be performed during surgery in two phases: 1) in-vivo and 2) ex-vivo. In the in-vivo phase surgeons will perform intraoral ultrasound with a small intraoral transducer in order to visualize size and boundaries of tumor. Then the surgeon begins the resection periodically pausing to obtain real-time images of the resection plane and determin if resection is performed at safe distance to the tumor. In th...もっと見る |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Free surgical margin | Free surgical margin defined as resection margin above 5mm on final histopathology report. Reported as dichotomous variable "free surgical margin yes/no" | 2 weeks. |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Surgeon assessed margins | Surgeons will intraoperatively try to predict the surgical margin on final histopathology report. This is important as it is not always possible to obtain free margin (above 5 mm). Therefore, this outcome will explore whether ultrasound is a viable tool to assess surgical margins regardless of whether the surgeon has obtained a "free surgical margin". | 2 weeks. |
Dysphagia questionnaire | MD Anderson Dysphagia Inventory to assess dysphagia at 3 and 12 months. | 12 months |
Cancer recurrence | This outcome will explore whether the use of ultrasound leads to more complete removal of cancerous tissue. | 24 months |
Survial | This outcome will explore whether an expected increased frequency of "free surgical margins" in the intervention group also reflects on survival. | 24 months |
Quality of life questionnaire | EORTC HN43 quality of life questionnaire in order to assess quality of life after head and neck cancer. | 12 months |
参加アシスタント
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
• Patients scheduled for surgical treatment of biopsy-proven T1-T3 oral squamous cell carcinoma.
- Age < 18 years.
- Oral cancer with suspected bone involvement.
- Unable to understand verbal or written information.
- Prior radiotherapy treatment of oral cavity cancer.
- Tumor not visible on ultrasound.
Tobias Todsen責任者
Tobias Todsen, 治験依頼者・主任研究者, MD, PhD, Ass. Prof., Rigshospitalet, Denmark
試験中央連絡先
連絡先: Daniel J Lauritzen, MD, +4541817574, [email protected]
7 5カ国の場所
California
Stanford Otolaryngology - Head & Neck Surgery Department, Stanford, California, 94305, United States
Lisa A Orloff, MD, FACS, FACE, 連絡先, (650) 736-1680, [email protected]
Michelle Chen, Ass. Prof., 連絡先, [email protected]
募集準備中
Georgia
Emory University Hospital, Atlanta, Georgia, 30322, United States
Merry E Sebelik, 連絡先, 404-778-3381, [email protected]
募集準備中
Department of Otorhinolaryngology Head and Neck Surgery, Aarhus, 8200, Denmark
Thomas Kjærgaard, MD, PhD, 連絡先, +4578450000, [email protected]
募集中
Department of Otorhinolaryngology Head and Neck Surgery and Audiology, Rigshospitalet, Copenhagen, Denmark
Tobias Todsen, MD, PhD, Ass. Prof., 連絡先, +4535453545, [email protected]
Daniel J Lauritzen, MD, 主任研究者
募集中
Istituto Nazionale Tumori of Milan, Milan, 20133, Italy
Alberto Deganello, 連絡先, +39 02 23901, [email protected]
募集準備中
Groote Schuur, Cape Town, 7935, South Africa
Matthew White, 連絡先, +27 21 404 9111, [email protected]
募集準備中
Karolinska Institute, Stockholm, 17177, Sweden
Mathias von Beckerath, 連絡先, +46 8 524 800 00, [email protected]
募集準備中