NCT02388308: Clarity-Pro

Evaluation of Clarity Ultrasound Guidance for Prostate Therapy

Completed Last updated 19 June 2018

What this trial tests

trial testing Clarity ultrasound in Prostate Cancer in 61 participants. Completed in 18 June 2018.

Timeline

15 May 2015

Primary endpoint
18 June 2018

18 June 2018

Quick facts

Lead sponsor	Institute of Cancer Research, United Kingdom
Status	Completed
Study type	OBSERVATIONAL
Enrollment	61
Start date	15 May 2015
Primary completion	18 June 2018
Estimated completion	18 June 2018
Sites	1 location across United Kingdom

Drugs / interventions tested

• Clarity ultrasound

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

Institute of Cancer Research, United Kingdom

Who can join

18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Radiotherapy (RT) is an important treatment for prostate cancer with over 10,000 men receiving RT per year in the UK. Prostate RT aims to deliver radiation dose to the prostate to kill cancer cells whilst minimizing the dose given to surrounding normal tissues, such as the bladder or the rectum. Radiation is delivered in a number of daily treatments which are called 'fractions'. The position of the prostate varies each day and during the radiation delivery. To accurately aim the radiation the prostate needs to be located before daily treatment. Clarity is an ultrasound image guidance system that locates the prostate and monitors its position during treatment. Ultrasound does not give a radiation dose, is non-invasive, provides fast imaging and can easily visualise soft tissues. Before Clarity is implemented the investigators wish to ensure that it can accurately locate and monitor the prostate by comparing Clarity with marker-based techniques in 24 patients. Patients receive markers as part of other trials which are currently recruiting at The Royal Marsden (for example, patients in the DELINEATE trial and the PACE trials receive implanted gold markers and patients in the PROSPARE trial have received electromagnetic markers). Patients who have received or will be receiving markers as part of other studies will be asked to also to take part in this study. This means that there will be no additional intervention for patients as a result of this study. Clarity will be considered a safe and effective imaging system if the mean and standard deviation of the differences between Clarity measurements and marker measurements, of prostate position, are less than 1mm. It is possible that markers will influence the Clarity measurements. To find out if this happens, the mean and standard deviation of Clarity measurements in a group of 24 patients without markers to the group with markers will be compared.

Primary Aim: To evaluate the accuracy of Clarity ultrasound image guidance system for prostate motion estimation during treatment (intra-fraction), by comparison with implanted marker-based image guidance techniques.

Primary Hypothesis: Clarity can be safely used to deliver radiotherapy using similar (within 1mm) treatment margins to those that would be employed if fiducial markers based image guidance techniques were used.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. In Vivo Validation of Elekta's Clarity Autoscan for Ultrasound-based Intrafraction Motion Estimation of the Prostate During Radiation Therapy.
   Grimwood A, McNair HA, O'Shea TP, Gilroy S, et al · · 2018 · cited 31× · PMID 29859785 · DOI 10.1016/j.ijrobp.2018.04.008
2. Factors affecting accuracy and precision in ultrasound guided radiotherapy.
   Grimwood A, Thomas K, Kember S, Aldis G, et al · · 2021 · cited 3× · PMID 34258411 · DOI 10.1016/j.phro.2021.05.003
3. Improving 3D ultrasound prostate localisation in radiotherapy through increased automation of interfraction matching.
   Grimwood A, Rivaz H, Zhou H, McNair HA, et al · · 2020 · cited 3× · PMID 32387546 · DOI 10.1016/j.radonc.2020.04.044