Prostate Cancer(CurieInVivo)NCT07580651
Quality and Safety of Real-Time Brachytherapy Treatments: Clinical Implementation of a Multipoint Scintillation Detector for Treatment Monitoring
A study testing Brachytherapy treatment monitoring using a plastic scintillation detector in people with Prostate Cancer and Gynecologic Cancers, run by CISSS de Chaudière-Appalaches.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer, Gynecologic Cancers
- What is being tested?
- Brachytherapy treatment monitoring using a plastic scintillation detector
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2027to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients receiving prostate brachytherapy treatment, or female user receiving gynecological brachytherapy treatment for cervical cancer.
Who cannot join
- Patients with a Clostridium difficile infection or any other high-risk positive infection.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
- Conditions
- Prostate Cancer, Gynecologic Cancers
- Being tested
- Brachytherapy treatment monitoring using a plastic scintillation detector
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brachytherapy treatment monitoring using a plastic scintillation detectorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| In-vivo dosimetry | Experimental | 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. Receives: Device: Brachytherapy treatment monitoring using a plastic scintillation detector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of brachytherapy treatments with successful scintillation detector-based measurement
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.
Measured: From the patient anesthesia at the beginning of the brachytherapy procedure to the end of brachytherapy radiation delivery on the same day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start15 Jan 2027 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CISSS de Chaudière-Appalaches
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mathieu Goulet, CISSS de Chaudière-Appalaches
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07580651
- Sponsor's protocol ID
- 2027-1305
- Other IDs
- 2025
- Acronym
- (CurieInVivo)
- Status last verified
- Oct 2026
- First submitted
- 31 Mar 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing of individual participant data, under Quebec Law, is heavily regulated, especially for data shared outside of the Province. For regulatory simplicity, the investigators would prefer not sharing the individual participant data.
Publications
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.
PubMed 33458336Linares 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.
PubMed 30891803Linares 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.
PubMed 33222208Therriault-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.
PubMed 23718599Kubo 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.
PubMed 9571605Hoopes 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.
PubMed 26362705Therriault-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.
PubMed 23060069Beaulieu 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.
PubMed 27694714Yamada 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.
PubMed 22265435
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Surveillance of Brachytherapy Using Plastic Scintillation Dosimetry: A Clinical Feasibility Study
- ClinicalTrials.gov ID
- NCT07580651
- Acronym / sponsor ID
- (CurieInVivo) / 2027-1305
- Conditions
- Prostate Cancer, Gynecologic Cancers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- CISSS de Chaudière-AppalachesOther government
- Study start
- 15 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| In-vivo dosimetry | Experimental | Device: Brachytherapy treatment monitoring using a plastic scintillation detectorPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients receiving prostate brachytherapy treatment, or female user receiving gynecological brachytherapy treatment for cervical cancer.
Key exclusion criteria (1 listed)
- Patients with a Clostridium difficile infection or any other high-risk positive infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brachytherapy treatment monitoring using a plastic scintillation detectorTypical 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. | Device | In-vivo dosimetry |
Primary outcome
Proportion of brachytherapy treatments with successful scintillation detector-based measurement
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Background: PubMed 33458336Fonseca 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.
- Background: PubMed 30891803Linares 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.
- Background: PubMed 33222208Linares 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.
- Background: PubMed 23718599Therriault-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.
- Background: PubMed 9571605Kubo 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.
- Background: PubMed 26362705Hoopes 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.
- Background: PubMed 23060069Therriault-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.
- Background: PubMed 27694714Beaulieu 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.
- Background: PubMed 22265435Yamada 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.
- Individual participant dataSharing planned: No. Sharing of individual participant data, under Quebec Law, is heavily regulated, especially for data shared outside of the Province. For regulatory simplicity, the investigators would prefer not sharing the individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Brachytherapy treatment monitoring using a plastic scintillation detector in people with Prostate Cancer and Gynecologic Cancers, run by CISSS de Chaudière-Appalaches.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mathieu Goulet, PhD (1-418-835-7121 ext 14539, mathieu_goulet@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of brachytherapy treatments with successful scintillation detector-based measurement (time frame: From the patient anesthesia at the beginning of the brachytherapy procedure to the end of brachytherapy radiation delivery on the same day.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07580651, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.