Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Inter-observer variability
- timeFrame
- through study completion, an average of 6 months
- description
- 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.
Secondary outcomes (3)
- measure
- Clinical factors influencing inter-observer variability.
- timeFrame
- through study completion, an average of 6 months
- description
- Subgroup analysis of radio-clinical-histological factors likely to influence inter-observer variability.
- measure
- Assessing inter-sequence reproducibility
- timeFrame
- through study completion, an average of 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.)
References
Publications (0)
Data not yet available