Prostate CancerVARIOPNCT05996289
Inter-observer Variability in the Segmentation of Prostate Tumour Lesions Using Multiparametric MRI (VARIOP)
An observational study of Prostate Cancer, run by University Hospital, Brest at 1 site in France.
Trial summary
Following the major technological and scientific advances in external radiotherapy in recent decades, thanks to the use of three-dimensional conformal techniques combined with intensity modulation, image-guided radiotherapy has enabled radiotherapists to increase doses without increasing sequelae and complications… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2023to 1 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patient treated or being treated for prostatic adenocarcinoma
Who may be able to join
- Age ≥ 18 years
- Histologically proven localized prostatic neoplasia on trans-rectal biopsies.
- Multiparametric prostate MRI performed prior to prostate biopsies.
- No opposition expressed
- Patient affiliated to a social security scheme
Who cannot join
- History of surgery, prostatic irradiation or hormonal treatment prior to diagnosis.
- History of prostate cancer
- No identifiable target lesion on mpMRI (<PIRADS 3)
- Opposition formulated
- Patient under legal protection (guardianship, curatorship, etc.)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Brest
Brest, 29609
Vincent Bourbonne, MD, PhD, +33298223398, vincent.bourbonne@chu-brest.fr
About this study
Official title: Inter-observer Variability in the Segmentation of Prostate Tumour Lesions Using Multiparametric MRI
Following the major technological and scientific advances in external radiotherapy in recent decades, thanks to the use of three-dimensional conformal techniques combined with intensity modulation, image-guided radiotherapy has enabled radiotherapists to increase doses without increasing sequelae and complications, giving rise to the term "dose escalation".
Following multiple dose-escalation clinical trials showing better biological control of PSA, the results of the latest phase 3 FLAME trial incorporated the notion of intraprostatic boost in relation to the primary prostate lesion, considered to be the preferred site of neoplastic recurrence in prostate cancer.
Read more
This leads to the first question, which concerns the identification of the dominant lesion and its precise delimitation. This last point is subject to variation between operators. A retrospective cohort from the Finistère region will therefore be used to develop a number of study points relating to :
inter-operator contour variability
- Factors influencing contour
- Impact of contour variability on dosimetry
- Automatic segmentation
Read the detailed description
Following the major technological and scientific advances in external radiotherapy in recent decades, thanks to the use of three-dimensional conformal techniques combined with intensity modulation, image-guided radiotherapy has enabled radiotherapists to increase doses without increasing sequelae and complications, giving rise to the term "dose escalation".
Following multiple dose-escalation clinical trials showing better biological control of PSA, the results of the latest phase 3 FLAME trial incorporated the notion of intraprostatic boost in relation to the primary prostate lesion, considered to be the preferred site of neoplastic recurrence in prostate cancer.
One of the issues raised by such a study is the methodology used to contour the tumour lesion, an issue which concerns the whole field of radiotherapy. The reference imaging technique for diagnosing prostate cancer, and more specifically the dominant tumour lesion, is multiparametric Magnetic Resonance Imaging. This leads to the first question, which concerns the identification of the dominant lesion and its precise delimitation. This last point is subject to variation between operators. A retrospective cohort from the Finistère region will therefore be used to develop a number of study points relating to :
inter-operator contour variability
- Factors influencing contour
- Impact of contour variability on dosimetry
- Automatic segmentation
- Conditions
- Prostate Cancer
- Keywords
- radiotherapy, MRI, segmentation
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-observer variability
The main criterion for judging inter-observer variability is the spatial overlap of contours on mpMRI, represented by the DICE similarity coefficient, which ranges from 0 to 1, where 1 represents zero variability between contours of the same lesion.
Measured: through study completion, an average of 6 months
Secondary outcomes (3)
Clinical factors influencing inter-observer variability.
Subgroup analysis of radio-clinical-histological factors likely to influence inter-observer variability.
Measured: through study completion, an average of 6 months
Assessing inter-sequence reproducibility
Assessing inter-sequence reproducibility
Measured: through study completion, an average of 6 months
Dosimetric impact of Inter-observer variability
The influence of variability on dosimetry in IMRT/VMAT conformal radiotherapy.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start1 Aug 2023
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Bourbonne, MD, PhD, Principal investigator, Radiation Oncology Department, Brest University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05996289
- Sponsor's protocol ID
- 29BRC23.0145 - VARIOP
- Acronym
- VARIOP
- Status last verified
- Aug 2023
- First submitted
- 1 Aug 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inter-observer Variability in the Segmentation of Prostate Tumour Lesions Using Multiparametric MRI
- ClinicalTrials.gov ID
- NCT05996289
- Acronym / sponsor ID
- VARIOP / 29BRC23.0145 - VARIOP
- Conditions
- Prostate Cancer
- Keywords
- radiotherapy, MRI, segmentation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 18 Aug 2023 (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.
Following the major technological and scientific advances in external radiotherapy in recent decades, thanks to the use of three-dimensional conformal techniques combined with intensity modulation, image-guided radiotherapy has enabled radiotherapists to increase doses without increasing sequelae and complications, giving rise to the term "dose escalation".
Following multiple dose-escalation clinical trials showing better biological control of PSA, the results of the latest phase 3 FLAME trial incorporated the notion of intraprostatic boost in relation to the primary prostate lesion, considered to be the preferred site of neoplastic recurrence in prostate cancer.
This leads to the first question, which concerns the identification of the dominant lesion and its precise delimitation. This last point is subject to variation between operators. A retrospective cohort from the Finistère region will therefore be used to develop a number of study points relating to :
inter-operator contour variability
- Factors influencing contour
- Impact of contour variability on dosimetry
- Automatic segmentation
Detailed description
Following the major technological and scientific advances in external radiotherapy in recent decades, thanks to the use of three-dimensional conformal techniques combined with intensity modulation, image-guided radiotherapy has enabled radiotherapists to increase doses without increasing sequelae and complications, giving rise to the term "dose escalation".
Following multiple dose-escalation clinical trials showing better biological control of PSA, the results of the latest phase 3 FLAME trial incorporated the notion of intraprostatic boost in relation to the primary prostate lesion, considered to be the preferred site of neoplastic recurrence in prostate cancer.
One of the issues raised by such a study is the methodology used to contour the tumour lesion, an issue which concerns the whole field of radiotherapy. The reference imaging technique for diagnosing prostate cancer, and more specifically the dominant tumour lesion, is multiparametric Magnetic Resonance Imaging. This leads to the first question, which concerns the identification of the dominant lesion and its precise delimitation. This last point is subject to variation between operators. A retrospective cohort from the Finistère region will therefore be used to develop a number of study points relating to :
inter-operator contour variability
- Factors influencing contour
- Impact of contour variability on dosimetry
- Automatic segmentation
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient treated or being treated for prostatic adenocarcinoma
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Histologically proven localized prostatic neoplasia on trans-rectal biopsies.
- Multiparametric prostate MRI performed prior to prostate biopsies.
- No opposition expressed
- Patient affiliated to a social security scheme
Key exclusion criteria (5 listed)
- History of surgery, prostatic irradiation or hormonal treatment prior to diagnosis.
- History of prostate cancer
- No identifiable target lesion on mpMRI (<PIRADS 3)
- Opposition formulated
- Patient under legal protection (guardianship, curatorship, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inter-observer variability
Time frame: through study completion, an average of 6 months
The main criterion for judging inter-observer variability is the spatial overlap of contours on mpMRI, represented by the DICE similarity coefficient, which ranges from 0 to 1, where 1 represents zero variability between contours of the same lesion.
3 secondary outcomes
Clinical factors influencing inter-observer variability.
Time frame: through study completion, an average of 6 months
Assessing inter-sequence reproducibility
Time frame: through study completion, an average of 6 months
Dosimetric impact of Inter-observer variability
Time frame: through study completion, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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. This study is not recruiting at the moment.
Vincent Bourbonne, MD, PhD principal investigator
Radiation Oncology Department, Brest University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by University Hospital, Brest at 1 site in France.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincent BOURBONNE, MD, PhD (+33298223398, vincent.bourbonne@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-observer variability (time frame: through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Aug 2023.