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Status unknownNCT02123888SCARTUpdated Feb 9, 2015

Simultaneous CBCT Acquisition During Arc Radiotherapy

An interventional study of Cone Beam Computed Tomography in Prostate Cancer and Lung Cancer, sponsored by Sally Falk. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-02-09.

Sponsored by Sally Falk · Not applicable and Interventional

The sponsor has not verified this record recently (last verified Feb 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Prostate Cancer
  • Lung Cancer

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Keywords

  • Prostate
  • Lung
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 75 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Sally Falk is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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
05

Study design

Phase
Not applicable
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
75 participants (estimated)

Study arms

  • Experimental
    Cone Beam Computed Tomography

    Simultaneous Cone Beam Computed Tomography acquisition during arc radiotherapy.

    Radiation: Cone Beam Computed Tomography

Interventions

  • RadiationCone Beam Computed Tomography

    Simultaneous Cone Beam Computed Tomography acquisition during arc radiotherapy

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 months

Secondary outcomes

  1. Quantify inter-observer variation

    To quantify inter-observer variation in interpretation of anatomy, as assessed by questionaires.

    Time frame: 12 months

  2. Quantify inter-observer variation

    To quantify inter-observer variation in delineation of specific structures on CBCT scans.

    Time frame: 12 months

  3. Quantify impact on treatment times.

    To quantify the impact of simultaneous CBCT scans on treatment times.

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • The Christie NHS Foundation Trust
    Manchester, Greater Manchester M20 4BX, United Kingdom
    • Julie Stratford · Contact · julie.stratford@christie.nhs.uk · 0044 (0)161 446 3506
    • Corinne Faivre-Finn · Principal investigator
    • Ananya Choudhury · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02123888
Lead sponsor
Sally Falk
Responsible party
Sally Falk (Clinical Trial Project Manager, The Christie NHS Foundation Trust) — Sponsor-investigator
First posted
Apr 28, 2014
Start date
Jun 2011
Primary completion
Dec 2015 (estimated)
Completion
Dec 2015 (estimated)
Last update
Feb 9, 2015

Study contacts

Corinne Faivre-Finn, MD PhD
Contact
corinne.finn@christie.nhs.uk
0044 (0) 161 446 8290
Julie Stratford
Contact
julie.stratford@christie.nhs.uk
0044 (0) 161 446 3506
Corinne Faivre-Finn, MD PhD
principal investigator · The Christie NHS Foundation Trust
Ananya Choudhury
principal investigator · The Christie NHS Foundation Trust

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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