Simultaneous CBCT Acquisition During Arc Radiotherapy

Prostate Cancer Clinical Trial

— SCART  

Official title:

Simultaneous Cone Beam Computed Tomography (CBCT) Acquisition During Arc Radiotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02123888
• Other study ID #: 10_RADIO_94
• Status: Recruiting
• Phase: N/A
• First received: April 22, 2014
• Last updated: February 6, 2015
• Start date: June 2011
• Est. completion date: December 2015

Study information

• Verified date: February 2015
• Source: Christie Hospital NHS Foundation Trust
• Contact: Corinne Faivre-Finn, MD PhD
• Phone: 0044 (0) 161 446 8290
• Email: corinne.finn[@]christie.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The cone beam image is a part of the radiotherapy treatment machine and uses lower energy xrays as the head of the radiotherapy machine moves around the patient in a circle. This takes pictures that give 3-dimensional information, somewhat like a CT scan. These images are better at showing the position of the tumour and surrounding soft tissues than the standard xrays that were previously used. Cone Beam Imaging Technology is not new and has been used regularly at The Christie for many years. The standard cone beam scan is taken before the actual radiotherapy treatment or after the treatment has been delivered.

Volumetric Modulated Arc Therapy (VMAT or Arc Radiotherapy) is a novel method of delivering radiotherapy that involves the continuous movement of the radiotherapy treatment machine head around the patient and MLC during radiation. Arc radiotherapy has been clinically implemented at The Christie for prostate radiotherapy treatments and work is in progress for implementation in lung radiotherapy. The continuous gantry rotation inherent to VMAT delivery makes this simultaneous imaging possible, although there are concerns associated with the impact that this may have on patient dose and image quality.

The aim of this research is to assess whether the image quality of cone beam scans taken during treatment are as good as standard cone beam scans taken before or after treatment used to determine the accuracy of patient position and the tumour coverage by radiotherapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria for prostate cancer patients:

• Patients to be treated with radical RT for prostate cancer

• Patients to be treated with VMAT

• ECOG performance status 0-2

• Patients must be able to receive and understand verbal and written information regarding the study and give written, informed consent

Inclusion Criteria for lung cancer patients:

• A histological or cytological diagnosis of non-small cell lung cancer or small cell lung cancer

• Patients to be treated with radical RT or SBRT

• Patients to be treated with VMAT

• ECOG performance status 0-2

• Patients must be able to receive and understand verbal and written information regarding the study and give written, informed consent

• Female patients must meet one of the following criteria - postmenopausal for a minimum of one year, surgically sterile, not pregnant, confirmed by ß-HCG blood test and willing to use adequate contraception during study participation, not breastfeeding

Exclusion Criteria for prostate cancer patients:

• Clinical judgement by the investigator that the patient should not participate in the study

• Patients in clinical trials of new investigational medicinal products or treatment regimens unless there is written, prior agreement that the patient can also consent to this study, and that clinical data can also be used for this study

• Prior radiotherapy or surgery in the pelvis that can make identification of normal anatomy difficult

Exclusion criteria for lung cancer patients:

• Clinical judgement by the investigator that the patient should not participate in the study

• Patients in clinical trials of new investigational medicinal products or treatment regimens unless there is written, prior agreement that the patient can also consent to this study, and that clinical data can also be used for this study

• Prior radiotherapy or surgery in the region of interest that can make identification of normal anatomy difficult

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Lung Cancer
• Prostate Cancer

Intervention

Radiation:
• Cone Beam Computed Tomography
Simultaneous Cone Beam Computed Tomography acquisition during arc radiotherapy

Locations

Country	Name	City	State
United Kingdom	The Christie NHS Foundation Trust	Manchester	Greater Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Sally Falk

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Equivalence of image quality	To show equivalence of image quality from simultaneous CBCT acquisition during delivery of arc radiotherapy with that obtained from conventional CBCT acquisition in lung and prostate patients, as assessed by user-questionnaires.	12 months	No
Secondary	Quantify inter-observer variation	To quantify inter-observer variation in interpretation of anatomy, as assessed by questionaires.	12 months	No
Secondary	Quantify inter-observer variation	To quantify inter-observer variation in delineation of specific structures on CBCT scans.	12 months	No
Secondary	Quantify impact on treatment times.	To quantify the impact of simultaneous CBCT scans on treatment times.	12 months	No