- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07580651
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Mathieu Goulet, PhD
- Numero di telefono: 1-418-835-7121 ext 14539
- Email: mathieu_goulet@ssss.gouv.qc.ca
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Proportion of brachytherapy treatments with successful scintillation detector-based measurement
Lasso di tempo: 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.
|
Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2026-1305
- 2025 (Altro numero di sovvenzione/finanziamento: Fondation de l'Hôtel-Dieu de Lévis)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Cancro alla prostata
-
Zeba Ahmad, Ph.D.American Cancer Society, Inc.ReclutamentoCaregiving for CancerStati Uniti
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletatoAdenocarcinoma dell'intestino tenue | Adenocarcinoma dell'intestino tenue in stadio III AJCC v8 | Adenocarcinoma dell'intestino tenue in stadio IIIA AJCC v8 | Adenocarcinoma dell'intestino tenue in stadio IIIB AJCC v8 | Adenocarcinoma dell'intestino tenue stadio IV AJCC v8 | Ampolla di Vater... e altre condizioniStati Uniti
-
Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen...CompletatoStudio delle donne cinesi che non hanno aderito alle linee guida per lo screening mammografico dell'American Cancer SocietyStati Uniti
-
Institut Cancerologie de l'OuestAttivo, non reclutanteQualità della vita al lavoro | Professionisti paramedici | Toccare Massaggio | Cancer CenterFrancia
-
Emory UniversityNational Cancer Institute (NCI)RitiratoCancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nel cervello | Carcinoma mammario metastatico | Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8
-
Yonsei UniversityNon ancora reclutamentoRAS/BRAF Wild-Type Advanced Cancer MathementCorea, Repubblica di
-
NRG OncologyNational Cancer Institute (NCI)CompletatoCancro al seno in stadio anatomico IV AJCC v8 | Cancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nell'osso | Neoplasia maligna metastatica nei linfonodi | Neoplasia maligna metastatica nel fegato | Carcinoma mammario metastatico | Neoplasia maligna metastatica nel... e altre condizioniStati Uniti, Canada, Arabia Saudita, Corea del Sud
-
Jonsson Comprehensive Cancer CenterReclutamentoAdenocarcinoma prostatico | Cancro alla prostata in stadio II AJCC v8 | Fase I Cancro alla prostata American Joint Committee on Cancer (AJCC) v8Stati Uniti
-
Jonsson Comprehensive Cancer CenterNovartis PharmaceuticalsReclutamentoCarcinoma della prostata | Stadio IVB Cancro alla prostata American Joint Committee on Cancer (AJCC) v8Stati Uniti
-
Second Affiliated Hospital, School of Medicine,...Attivo, non reclutanteElettroacopuntura combinata con paclitaxel legato alla proteina e anticorpo PD-1 per il trattamento di seconda linea di HER2 negativo, PMMR/MSS Advanced Gastric CancerCina