Simultaneous CBCT Acquisition During Arc Radiotherapy

NCT ID: NCT02123888

Last Updated: 2015-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Cancer Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cone Beam Computed Tomography

Simultaneous Cone Beam Computed Tomography acquisition during arc radiotherapy.

Group Type EXPERIMENTAL

Cone Beam Computed Tomography

Intervention Type RADIATION

Simultaneous Cone Beam Computed Tomography acquisition during arc radiotherapy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cone Beam Computed Tomography

Simultaneous Cone Beam Computed Tomography acquisition during arc radiotherapy

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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
* 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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sally Falk

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sally Falk

Clinical Trial Project Manager

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Corinne Faivre-Finn, MD PhD

Role: PRINCIPAL_INVESTIGATOR

The Christie NHS Foundation Trust

Ananya Choudhury

Role: PRINCIPAL_INVESTIGATOR

The Christie NHS Foundation Trust

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Christie NHS Foundation Trust

Manchester, Greater Manchester, United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Corinne Faivre-Finn, MD PhD

Role: CONTACT

0044 (0) 161 446 8290

Julie Stratford

Role: CONTACT

0044 (0) 161 446 3506

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Julie Stratford

Role: primary

0044 (0)161 446 3506

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

10_RADIO_94

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pencil Beam Scanning in Patients With Renal Tumors
NCT03810651 RECRUITING EARLY_PHASE1