Prostate CancerSCARTNCT02123888
Simultaneous CBCT Acquisition During Arc Radiotherapy
A study testing Cone Beam Computed Tomography in people with Prostate Cancer and Lung Cancer, run by Sally Falk at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer, Lung Cancer
- What is being tested?
- Cone Beam Computed Tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2011to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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
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- 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
Who cannot join
- 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
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
The Christie NHS Foundation Trust
Manchester, Greater Manchester, M20 4BX
Julie Stratford, 0044 (0)161 446 3506, julie.stratford@christie.nhs.uk
Corinne Faivre-Finn
About this study
Official title: Simultaneous Cone Beam Computed Tomography (CBCT) Acquisition During Arc Radiotherapy
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.
- Conditions
- Prostate Cancer, Lung Cancer
- Being tested
- Cone Beam Computed Tomography
- Keywords
- Prostate, Lung
- Medical subject headings
- Prostatic Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cone Beam Computed TomographyRadiation
Simultaneous Cone Beam Computed Tomography acquisition during arc radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Cone Beam Computed Tomography | Experimental | Simultaneous Cone Beam Computed Tomography acquisition during arc radiotherapy. Receives: Radiation: Cone Beam Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (3)
Quantify inter-observer variation
To quantify inter-observer variation in interpretation of anatomy, as assessed by questionaires.
Measured: 12 months
Quantify inter-observer variation
To quantify inter-observer variation in delineation of specific structures on CBCT scans.
Measured: 12 months
Quantify impact on treatment times.
To quantify the impact of simultaneous CBCT scans on treatment times.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2014 (estimated)
- Study startJun 2011
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sally Falk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sally Falk, The Christie NHS Foundation Trust
- Investigators
- Corinne Faivre-Finn, MD PhD, Principal investigator, The Christie NHS Foundation TrustAnanya Choudhury, Principal investigator, The Christie NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02123888
- Sponsor's protocol ID
- 10_RADIO_94
- Acronym
- SCART
- Status last verified
- Feb 2015
- First submitted
- 22 Apr 2014
- Last updated
- 9 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous Cone Beam Computed Tomography (CBCT) Acquisition During Arc Radiotherapy
- ClinicalTrials.gov ID
- NCT02123888
- Acronym / sponsor ID
- SCART / 10_RADIO_94
- Conditions
- Prostate Cancer, Lung Cancer
- Keywords
- Prostate, Lung
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Sally FalkUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 28 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cone Beam Computed Tomography | Experimental | Radiation: Cone Beam Computed TomographySimultaneous Cone Beam Computed Tomography acquisition during arc radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- A histological or cytological diagnosis of non-small cell lung cancer or small cell lung cancer
Key exclusion criteria (6 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cone Beam Computed TomographySimultaneous Cone Beam Computed Tomography acquisition during arc radiotherapy | Radiation | Cone Beam Computed Tomography |
Primary outcome
Equivalence of image quality
Time frame: 12 months
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.
3 secondary outcomes
Quantify inter-observer variation
Time frame: 12 months
Quantify inter-observer variation
Time frame: 12 months
Quantify impact on treatment times.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corinne Faivre-Finn, MD PhD principal investigator
The Christie NHS Foundation Trust
Ananya Choudhury principal investigator
The Christie NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cone Beam Computed Tomography in people with Prostate Cancer and Lung Cancer, run by Sally Falk at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Corinne Faivre-Finn, MD PhD (0044 (0) 161 446 8290, corinne.finn@christie.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Equivalence of image quality (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2015.