Prostate cancer Cancer
Conditions
Interventions
This is a single cohort non-comparative diagnostic study. The intervention is super-resolution contrast enhanced ultrasound imaging of the prostate with a new image processing method. Patients with pr
Sponsors
Heriot-Watt University
NHS Lothian
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 09/03/2026: 1. Known or undergoing investigation for suspected prostate cancer Previous inclusion criteria: 1. Known or suspected prostate cancer 2. Already planned to undergo radical prostatectomy as the primary treatment modality
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 09/03/2026: 1. Is unable or unwilling to give consent 2. Trans-rectal route is not accessible (e.g., a previous abdomino-perineal resection) 3. Has a known allergy to the ultrasound contrast agent 4. Has a contraindication or a relative contraindication to receiving the contrast agent as stipulated by the manufacturer Previous exclusion criteria: 1. Unable or unwilling to give consent 2. Known allergy to the ultrasound contrast agent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Identification of index prostate tumours by SR-CEUS. The data will be collected during the ultrasound scan, with approximately 30 mins in total for multiple videos to be saved. Histological prostate gland examination will be performed by a pathologist within 2 weeks of ultrasound scan and used as the reference standard. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The comparative accuracy of bolus and continuous infusion of contrast regimes for prostate tumour detection 2. A qualitative assessment of the benefits of each contrast agent to include: 2.1. Feasibility of full image acquisition within maximum allowed dosage 2.2. Resolution of tumour imaging 2.3. Qualitative assessment of preference from the radiologist performing the procedure 3. Duration of ultrasound scanning required to obtain a full image set of the prostate gland 4. The association of prostate tumour SR-CEUS microvascular structure with prostate tumour pathological Gleason grade and pathological t stage 5. Tumour volume measured by SR-CEUS and using pathology techniques 6. Tumour volume location measured by SR-CEUS and using pathology techniques For all outcomes, the ultrasound videos will be saved after the procedure and processed using Matlab and ImageJ software at a later date, usually within the weeks after the original ultrasound scan. The resulting images from the ultrasound analysis will be compared to each other and to histological prostate data. The location and size of the tumour regions in the histology will be compared to that detected in the processed ultrasound data. | — |
Countries
Scotland, United Kingdom
Contacts
Public ContactMairead Butler
Outcome results
None listed