Clinical trial · Interventional
Imaging of High Grade Prostate Cancer
Detection of Malignant Calcifications in High Grade Prostate Cancer With Comedo-type Necrosis Using Thin Section Computed Tomography and Susceptibility Weighted Magnetic Resonance Imaging
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): trial logistics
Summary
Brief summary (as posted)
Management of prostatic carcinoma varies according to stage of disease. Trans-rectal ultrasound guided biopsy is known to underestimate the degree of tumor due to undersampling and random non-targeted technique. Methods to improve pre-operative tumor localization and grading, including multi-parametric (MP) magnetic resonance imaging (MRI) is an active area of research but requires further validation. High grade tumors can undergo comedo-type necrosis with malignant calcifications which only occurs in Gleason pattern 5 tumors and which we hypothesize can be reliably detected using computed tomography (CT) and/or MRI. Detection of malignant calcification within tumor foci will improve the accuracy of localization and grading in prostatic carcinoma.
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 |
|---|---|---|---|
| Prostatic Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imaging | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Imaging - CT and MRI examinations
- description
- Abdominal and pelvic CT and pelvic MRI imaging will be performed in 30 patients.
- interventionNames
- Device: Imaging
Primary outcomes (1)
- measure
- The number of prostate patients with comedo-type necrosis.
- timeFrame
- up to 4 weeks
- description
- Two radiologists will review the MRI and CT examinations separated by a 4 week interval to decrease recall bias. Further, readers will review the 3 additional gradient echo pulse sequences independently at 3 different MRI reading sessions, also separated by 4 weeks, in order to compare the accuracy from each pulse sequence and to reduce recall bias.
Secondary outcomes (1)
- measure
- The number of other features measured on MRI.
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * Patients with malignant comedo-type necrosis and calcifications detected with histo-pathology from guided biopsies * Patients with biopsy proven Gleason pattern 5 tumor and without comedo-type necrosis associated calcification Exclusion Criteria: * Patients who do not have malignant comedo-type necrosis and calcifications detected with histo-pathology from guided biopsies
References
Publications (0)
Data not yet available