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Inter-observer Variability in the Segmentation of Prostate Tumour Lesions Using Multiparametric MRI (VARIOP)

Inter-observer Variability in the Segmentation of Prostate Tumour Lesions Using Multiparametric MRI

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05996289
Acronym
VARIOP
Enrollment
70
Registered
2023-08-18
Start date
2023-08-01
Completion date
2024-07-01
Last updated
2023-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

radiotherapy, MRI, segmentation

Brief 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, 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

Interventions

None listed

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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.)

Design outcomes

Primary

MeasureTime frameDescription
Inter-observer variabilitythrough study completion, an average of 6 monthsThe 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.

Secondary

MeasureTime frameDescription
Clinical factors influencing inter-observer variability.through study completion, an average of 6 monthsSubgroup analysis of radio-clinical-histological factors likely to influence inter-observer variability.
Assessing inter-sequence reproducibilitythrough study completion, an average of 6 monthsAssessing inter-sequence reproducibility
Dosimetric impact of Inter-observer variabilitythrough study completion, an average of 6 monthsThe influence of variability on dosimetry in IMRT/VMAT conformal radiotherapy.

Other

MeasureTime frameDescription
Automatic segmentation of prostatic tumorsthrough study completion, an average of 6 monthsContour variability using a deep-learning automated segmentation technique, with and without implementation of factors identified as impacting contour in manual technique.

Countries

France

Contacts

Primary ContactVincent BOURBONNE, MD, PhD
vincent.bourbonne@chu-brest.fr+33298223398

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026