Inter-observer Variability in the Segmentation of Prostate Tumour Lesions Using Multiparametric MRI (VARIOP)
NCT ID: NCT05996289
Last Updated: 2023-08-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
70 participants
OBSERVATIONAL
2023-08-01
2024-07-01
Brief Summary
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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
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Detailed Description
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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
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Study Design
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COHORT
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* History of prostate cancer
* No identifiable target lesion on mpMRI (\<PIRADS 3)
* Opposition formulated
* Patient under legal protection (guardianship, curatorship, etc.)
18 Years
ALL
No
Sponsors
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University Hospital, Brest
OTHER
Responsible Party
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Principal Investigators
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Vincent Bourbonne, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Radiation Oncology Department, Brest University Hospital
Locations
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Chu Brest
Brest, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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29BRC23.0145 - VARIOP
Identifier Type: -
Identifier Source: org_study_id
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