Quality and Safety of Real-Time Brachytherapy Treatments: Clinical Implementation of a Multipoint Scintillation Detector for Treatment Monitoring ((CurieInVivo))
In Vivo Surveillance of Brachytherapy Using Plastic Scintillation Dosimetry: A Clinical Feasibility Study
This project addresses a key safety gap in High-Dose-Rate (HDR) brachytherapy, where very high, localized radiation doses mean that small geometric deviations in catheter placement or radioactive source positioning can cause clinically significant errors. Incident reports from the Radiation Oncology Incident Learning System (RO-ILS) of the American Society for Radiation Oncology (ASTRO) and guidelines from the American Association of Physicists in Medicine Task Group 59 (AAPM TG-59) identify these events-often occurring between imaging and treatment delivery-as among the most critical. Unlike external beam radiotherapy, brachytherapy lacks a prior phantom-based verification step, making in vivo dosimetry the only real-time method to confirm delivered dose and detect anomalies in dwell time or source position. International bodies such as the International Atomic Energy Agency (IAEA) recommend this approach for quality management and accident prevention.
Multipoint plastic scintillation detectors (mPSD) offer water-equivalent, real-time measurements and can enable three-dimensional (3D) radioactive source tracking, but their clinical use remains limited due to integration challenges and the absence of well-defined alert thresholds.
The project aims to implement a real-time in vivo monitoring solution using an mPSD at the Centre régional intégré de cancérologie (CRIC) of Lévis, Québec (QC) for HDR gynecological and prostate brachytherapy. Objectives include: (1) demonstrating clinical feasibility and integration within existing clinical workflows; (2) validating the accuracy and precision of dose, dwell-time, and source-position measurements under clinical conditions; and (3) developing practical alert thresholds to identify common deviations. The central hypothesis is that mPSD technology can provide reliable, reproducible real-time measurements without lengthening procedures or disrupting clinical workflow.
The methodology relies on adapting the HYPERSCINT® platform for HDR in vivo use. A custom mPSD, consisting of several scintillators along a single optical fiber, will be insertable into a 6-French (6F) catheter.
Phase 1 focuses on feasibility and integration, including HDR-specific calibration, definition of detector insertion scenarios, integration of acquisition hardware, and staff training.
Phase 2 validates performance in at least 20 patients. Planned treatment parameters and time-stamped detector signals acquired at 1-10 hertz (Hz) will be used to reconstruct delivered dose, dwell times, and source-to-detector distances. Measurement accuracy and reproducibility will be quantified using mixed-effects statistical models.
Phase 3 establishes preliminary alert thresholds based on deviations in dose, time, and position, along with visualization tools such as Bland-Altman plots, although these thresholds will not be applied clinically during the study.
Expected outcomes include demonstrated feasibility of in vivo mPSD monitoring, quantitative performance metrics with confidence intervals, identification of influential factors and operational recommendations, preliminary alert thresholds with reporting templates, and a roadmap for sustainable deployment in Lévis and other centers. Scientific outputs will also be produced for dissemination across the Santé Québec network.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Mathieu Goulet, PhD
- 電話番号:1-418-835-7121 ext 14539
- メール:mathieu_goulet@ssss.gouv.qc.ca
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Patients receiving prostate brachytherapy treatment, or female user receiving gynecological brachytherapy treatment for cervical cancer.
Exclusion Criteria:
- Patients with a Clostridium difficile infection or any other high-risk positive infection.
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:他の
- 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:In-vivo dosimetry
Patients in this treatment arm will receive the same treatment and care as patients outside of the protocol, but will have their treatment monitored by a plastic scintillation detector placed inside or at close proximity of the tumor.
|
Typical brachytherapy treatments are conducted without dose or source position monitoring in real-time.
This intervention will assess the feasibility of using a scintillation detector to that end.
|
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 |
|---|---|---|
|
Proportion of brachytherapy treatments with successful scintillation detector-based measurement
時間枠:From the patient anesthesia at the beginning of the brachytherapy procedure to the end of brachytherapy radiation delivery on the same day.
|
Feasibility will be assessed by determining whether a scintillation detector successfully acquires a measurement during brachytherapy treatment.
Radiation emitted from the brachytherapy source induces optical scintillation in the detector.
The emitted light is transmitted via optical fiber and collected by a spectrometer located outside the treatment room.
A successful measurement is defined as the acquisition of scintillation data that can be analyzed to infer clinically relevant parameters, including either the radiation dose rate as a function of time and/or the radioactive source position during treatment delivery.
The outcome will be reported as the number and proportion of treatments with successful measurements.
|
From the patient anesthesia at the beginning of the brachytherapy procedure to the end of brachytherapy radiation delivery on the same day.
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- Yamada Y, Rogers L, Demanes DJ, Morton G, Prestidge BR, Pouliot J, Cohen GN, Zaider M, Ghilezan M, Hsu IC; American Brachytherapy Society. American Brachytherapy Society consensus guidelines for high-dose-rate prostate brachytherapy. Brachytherapy. 2012 Jan-Feb;11(1):20-32. doi: 10.1016/j.brachy.2011.09.008.
- Fonseca GP, Johansen JG, Smith RL, Beaulieu L, Beddar S, Kertzscher G, Verhaegen F, Tanderup K. In vivo dosimetry in brachytherapy: Requirements and future directions for research, development, and clinical practice. Phys Imaging Radiat Oncol. 2020 Sep 28;16:1-11. doi: 10.1016/j.phro.2020.09.002. eCollection 2020 Oct.
- Linares Rosales HM, Duguay-Drouin P, Archambault L, Beddar S, Beaulieu L. Optimization of a multipoint plastic scintillator dosimeter for high dose rate brachytherapy. Med Phys. 2019 May;46(5):2412-2421. doi: 10.1002/mp.13498. Epub 2019 Apr 2.
- Linares Rosales HM, Johansen JG, Kertzscher G, Tanderup K, Beaulieu L, Beddar S. 3D source tracking and error detection in HDR using two independent scintillator dosimetry systems. Med Phys. 2021 May;48(5):2095-2107. doi: 10.1002/mp.14607. Epub 2021 Mar 28.
- Therriault-Proulx F, Beddar S, Beaulieu L. On the use of a single-fiber multipoint plastic scintillation detector for 192Ir high-dose-rate brachytherapy. Med Phys. 2013 Jun;40(6):062101. doi: 10.1118/1.4803510.
- Kubo HD, Glasgow GP, Pethel TD, Thomadsen BR, Williamson JF. High dose-rate brachytherapy treatment delivery: report of the AAPM Radiation Therapy Committee Task Group No. 59. Med Phys. 1998 Apr;25(4):375-403. doi: 10.1118/1.598232.
- Hoopes DJ, Dicker AP, Eads NL, Ezzell GA, Fraass BA, Kwiatkowski TM, Lash K, Patton GA, Piotrowski T, Tomlinson C, Ford EC. RO-ILS: Radiation Oncology Incident Learning System: A report from the first year of experience. Pract Radiat Oncol. 2015 Sep-Oct;5(5):312-318. doi: 10.1016/j.prro.2015.06.009. Epub 2015 Jun 25.
- Therriault-Proulx F, Archambault L, Beaulieu L, Beddar S. Development of a novel multi-point plastic scintillation detector with a single optical transmission line for radiation dose measurement. Phys Med Biol. 2012 Nov 7;57(21):7147-59. doi: 10.1088/0031-9155/57/21/7147. Epub 2012 Oct 12.
- Beaulieu L, Beddar S. Review of plastic and liquid scintillation dosimetry for photon, electron, and proton therapy. Phys Med Biol. 2016 Oct 21;61(20):R305-R343. doi: 10.1088/0031-9155/61/20/R305. Epub 2016 Oct 3.
研究記録日
主要日程の研究
研究開始 (推定)
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
本研究に関する用語
その他の研究ID番号
- 2026-1305
- 2025 (米国 NIH グラント/契約:Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
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?
IPD プランの説明
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
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。