Clinical trial NCT02123888: Simultaneous CBCT Acquisition During Arc Radiotherapy
Official title: Simultaneous Cone Beam Computed Tomography (CBCT) Acquisition During Arc Radiotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Lung Cancer
Keywords: Prostate
Lung
Lead sponsor: The Christie NHS Foundation Trust
Sponsor class: OTHER
First posted: 2014-04-28
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief 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.


Eligibility criteria: 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 β-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

Primary outcomes:
measure: Equivalence of image quality
timeFrame: 12 months
Secondary outcomes:
measure: Quantify inter-observer variation
timeFrame: 12 months
measure: Quantify inter-observer variation
timeFrame: 12 months
measure: Quantify impact on treatment times.
timeFrame: 12 months
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
state: Greater Manchester
Study officials:
affiliation: The Christie NHS Foundation Trust
name: Corinne Faivre-Finn, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Christie NHS Foundation Trust
name: Ananya Choudhury
role: PRINCIPAL_INVESTIGATOR
References: