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Active, Not Recruiting

NCT Number: NCT02514512

Lung Cancer Radiotherapy Using Realtime Dynamic Multileaf Collimator (MLC) Adaptation And Radiofrequency Tracking

A research study into a new technology for adjustment of the radiotherapy beam to account for movement of lung tumours as the patient breathes during radiotherapy.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal North Shore Hospital

St Leonards, New South Wales, 2112, Australia

About this study

Twenty patients 18 years of age or more and undergoing Stereotactic Body Radiotherapy (SBRT) at Northern Sydney Cancer Centre for lung cancer will receive the new treatment. Participants will be physically able to undergo all aspects of treatment and intellectually able to provide written informed consent and complete questionnaires. Beacons will be implanted in the patients' lung to allow the Multi Leaf Collimator (MLC) tracking equipment to follow precisely the movement of the lung. The difference in ability to track tumour movement between MLC and the current standard method will be compared to identify changes in study outcomes. Audiovisual (AV) Biofeedback will also be used to regulate patients' breathing during radiotherapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 or older
  • Has provided written Informed Consent for participation in this trial and is willing to comply with the study
  • Patients undergoing external beam radiotherapy at Northern Sydney Cancer Centre
  • Histologically proven Stage I Non Small Cell Lung Cancer (NSCLC) oligometastatic lung metastases (3 or less). Histological diagnosis will be obtained if clinically indicated.
  • MRI/4D-CT prior to insertion of Calypso beacons
  • Patient must be able to have Varian Calypso beacons placed in the lung (if on anticoagulants, must be cleared by Local Medical Officer (LMO) or cardiologist).
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Body habitus enabling Calypso tracking (as per Calypso Determining a Patient's Localisation Designation & Orientation before implantation)
  • A maximum of three metastases to the lung from any non-haematological malignancy. Multiple metastases will be treated separately.
  • Tumour diameter ≤ = 5cm

Exclusion criteria

  • Previous high-dose thoracic radiotherapy.
  • Less than two Calypso beacons implanted in the lung.
  • Calypso beacons are spaced by greater than 9cm or less than 1cm.
  • Calypso beacons are less than 19cm from outer chest wall
  • Cytotoxic chemotherapy within 3 weeks of commencement of treatment, or concurrently with treatment. Hormonal manipulation agents are allowable (e.g. aromatase inhibitors, selective oestrogen receptor modulators, and gonadotropin releasing hormone receptor modulators)
  • Targeted agents (such as sunitinib, bevacizumab and tarceva) within 7 days of commencement of treatment, or concurrently with treatment
  • Women who are pregnant or lactating.
  • Unwilling or unable to give informed consent
  • Unwilling or unable to complete quality of life questionnaires

Treatment and study plan

MLC Tracking

Device

Treat patient with Non FDA approved MLC Tracking

Primary outcomes

  1. To demonstrate feasibility of MLC tracking for lung cancer

    Time frame: Assessed at 2 years

    Percentage of fractions delivered without software or mechanical failure

Secondary outcomes

  1. Audio Visual (AV) Biofeedback

    Time frame: Assessed at 2 years

    Fraction of patients for whom AV biofeedback improves breathing regularity

  2. Coefficient of variation in breathing patterns

    Time frame: Assessed at 2 years

    Breathing variations over imaging and treatment sessions with and without AV biofeedback using a statistical process for coefficient of variation

  3. Target volumes

    Time frame: Assessed at 2 years

    Target volumes between the 4 Dimensional (4D) planning MLC tracking and Internal Target Volume (ITV) (standard) planning

  4. Lung dose

    Time frame: Assessed at 2 years

    Difference in dose to healthy lung in treatment plans between 4D planning and ITV planning

  5. Treated dose - MLC tracking

    Time frame: Assessed at 2 years

    Difference between the treated dose and planned dose for MLC tracking

  6. Treated dose - standard

    Time frame: Assessed at 2 years

    Difference between the estimated treated dose and planned dose for ITV treatments

  7. 4D Cone Beam CT (CBCT) image quality

    Time frame: Assessed at 2 years

    Image quality and target position differences between the Calypso-based 4D CBCT image reconstruction and Revs Per Minute (RPM)-based 4D CBCT image reconstruction using Feldkamp filtered backprojection (FDK and iterative reconstruction algorithms.

  8. Breathing variations with and without continuous positive air pressure (CPAP)

    Time frame: At time of treatment

    To quantify the breathing variations over treatment sessions with and without application of continuous positive air pressure (CPAP)

Other outcomes

  1. Patient Outcomes - Composite

    Time frame: 5 years

    Participants will be followed for 5 years to determine patient outcome3s, including radiation therapy toxicity, local control (whether the tumour has spread) and survival.

Sponsors and collaborators

Lead sponsor

Royal North Shore Hospital

Other

Collaborators

  • University of Sydney
  • Varian Medical Systems

Registry information

Official study title

Phase I Feasibility Study of Lung Cancer Radiotherapy Using Realtime Dynamic Multileaf Collimator (MLC) Adaptation and Radiofrequency Tracking

Acronym: LIGHTSABR

Important dates

Study start
2015
Primary completion
2023
Study completion
2026
First posted
Aug 3, 2015
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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