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Evaluation of Clarity Ultrasound Guidance for Prostate Therapy

NCT02388308 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 61

Last updated 2018-06-19

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Clarity ultrasound

Ultrasound imaging data will be recorded only. Treatment will not be altered as a result of this study.

Sponsors & Collaborators

  • Royal Marsden NHS Foundation Trust

    collaborator OTHER

  • Institute of Cancer Research, United Kingdom

    lead OTHER

Principal Investigators

  • Emma Harris · Institute of Cancer Research, United Kingdom

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-15
Primary Completion
2018-06-18
Completion
2018-06-18

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02388308 on ClinicalTrials.gov