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Trial record 1 of 1 for:    NCT04310891
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Markerless Image Guidance Using Intrafraction Kolovoltage X-ray Imaging for Lung Cancer Radiotherapy (VALKIM)

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ClinicalTrials.gov Identifier: NCT04310891
Recruitment Status : Recruiting
First Posted : March 17, 2020
Last Update Posted : June 3, 2021
Sponsor:
Collaborator:
University of Sydney
Information provided by (Responsible Party):
Dasantha Jayamanne, Royal North Shore Hospital

Brief Summary:
In radiotherapy, tumour tracking allows us to ensure the radiation beam is accurately targeting the tumour while it moves in a complex and unpredictable way. Most tumour tracking techniques require the implantation of fiducial markers around the tumour. Markerless Tumour Tracking negates the need for implanted markers, enabling accurate and optimal cancer radiotherapy in a non-invasive way.

Condition or disease Intervention/treatment
Lung Cancer Markerless Image Guidance Intrafraction Kolovoltage X-ray Imaging Radiation: Markerless Tumour Tracking

Detailed Description:

We will perform a phase I observational trial investigating the feasibility of the Markerless Tumour Tracking technology. Markerless Tumour Tracking will be integrated with existing treatment machines to provide real-time monitoring of tumour motion during treatment delivery. Eligible patients are implanted with fiducial markers, which act as the ground truth for evaluating the accuracy of Markerless Tumour Tracking. The patients will undergo the current standard of care radiotherapy, with the exception that kilovoltage x-ray images will be acquired continuously during treatment delivery and used to calculate online Markerless Tumour Tracking. Markerless Tumour Tracking determines the mean tumour position calculated over the most recent 15 seconds and displays shifts exceeding 3 mm.

The trial will be a single-institution study recruiting only at RNSH Radiation Oncology Department.

As this trial investigates feasibility, our focus will be on estimating the proportion of treatment time in which the Markerless Tumour Tracking is within acceptable limits.

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of Markerless Image Guidance Using Intrafraction Kolovoltage X-ray Imaging Using Implanted Fiducials: Phase I Observational Study of Lung Cancer Radiotherapy
Actual Study Start Date : December 4, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: X-Rays

Group/Cohort Intervention/treatment
Markerless
Markerless Tumour Tracking will be used to observe the radiation beam is accurately targeting the tumour.
Radiation: Markerless Tumour Tracking
Intrafraction Kolovoltage X-ray Imaging using Fiducials




Primary Outcome Measures :
  1. Markerless Tumour Tracking [ Time Frame: 6 months after recruitment ]
    to demonstrate the feasibility of Markerless Tumour Tracking for motion-adaptive lung cancer radiotherapy as assessed by agreement between markerless and marker-based tracking within 3 mm for at least 80% of the beam-on time as assessed in off-line analyses.


Secondary Outcome Measures :
  1. Markerless Tumour Tracking outcome [ Time Frame: 6 months after treatment of last fraction ]
    To identify cohort of patients on which markerless Tumour tracking performs well or poorly

  2. Accuracy [ Time Frame: 6 months after treatment of last fraction ]
    To quantify the accuracy of marker-based tracking by comparison with MV-kV triangulation or visual inspection

  3. Magnitude [ Time Frame: 6 months after treatment of last fraction ]
    To investigate the magnitude of surrogacy of lung tumour motion, ie the difference between tumour motion and implanted marker motion

  4. Correlation [ Time Frame: 6 months after treatment of last fraction ]
    To investigate the correlation between external and internal motion using infrared/optical imaging

  5. Suitability [ Time Frame: 6 months after treatment of last fraction ]
    To investigate the suitability and frequency of correcting for tumour baseline shifts based on a variety of tolerance criteria and with different methods

  6. Frequency [ Time Frame: 6 months after treatment of last fraction ]
    To investigate the frequency of correcting for tumour baseline shifts based on a variety of tolerance criteria and with different methods

  7. Feasibility of outcomes prediction [ Time Frame: 6 months after treatment of last fraction ]
    To investigate the feasibility of predicting treatment outcomes based on patient and imaging information

  8. Outcomes [ Time Frame: 6 months after treatment of last fraction ]
    Participants will be followed for 2 years to determine patient outcomes, including radiation therapy toxicity, local control (whether the tumour has spread) and survival

  9. Historical [ Time Frame: 6 months after treatment of last fraction ]
    2 year outcomes will be compared to historical outcomes reported from our lung Departmental SBRT database

  10. Ineligibility [ Time Frame: 6 months after treatment of last fraction ]
    To record the number of patients ineligible after marker insertion due to positioning of markers, or due to complications with the implantation procedure

  11. Radiomic Features [ Time Frame: 6 months after treatment of last fraction ]
    To investigate the feasibility of extracting radiomic features from CT, CBCT, and kV images to predict tumour volumes, tracking accuracy, treatment response, and patient outcomes.

  12. X-ray dose [ Time Frame: 6 months after treatment of last fraction ]
    To report additional x-ray dose caused by imaging during treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Adults >=18 years with NSCLC
Criteria

Inclusion Criteria:

  1. Aged 18 or older.
  2. Has provided written Informed Consent for participation in this trial and is willing to comply with the study.
  3. Patients undergoing external beam radiotherapy.
  4. Histologically proven Stage I NSCLC or oligometastatic lung metastases (3 or less).
  5. Diagnostic CT prior to insertion of fiducial markers.
  6. Patient must be able to have fiducial markers placed in the lung (if on anticoagulants, must be cleared by LMO or cardiologist).
  7. ECOG performance status 0-2.
  8. A maximum of three metastases to the lung from any non-haematological malignancy. Multiple metastases will be treated separately.
  9. 1 cm ≤ Tumour diameter in any dimension ≤ = 5 cm.
  10. The distance between the tumour centroid and the top end of the diaphragm is <=8 cm.

Exclusion Criteria:

  1. Patient has low respiratory performance as evaluated by the physicians.
  2. Previous high-dose thoracic radiotherapy.
  3. Less than one fiducial marker implanted in the lung.
  4. Fiducial markers are too far from the tumour centroid (>9 cm).
  5. 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).
  6. Targeted agents (such as sunitinib, bevacizumab and tarceva) within 7 days of commencement of treatment, concurrently with treatment or 7 days after radiotherapy.
  7. Women who are pregnant or lactating.
  8. Unwilling or unable to give informed consent.
  9. Unwilling or unable to complete quality of life questionnaires.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04310891


Contacts
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Contact: Carol Kwong, RN +61294631339 ext 31339 carolyn.kwong@health.nsw.gov.au
Contact: Heidi Tsang, RN +61294631340 ext 31340 heidi.tsang@health.nsw.gov.au

Locations
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Australia, New South Wales
Royal North Shore Hospital Recruiting
Saint Leonards, New South Wales, Australia, 2065
Contact: Carol Kwong, RN    +61 29463 1339 ext 31339    carolyn.kwong@health.nsw.gov.au   
Contact: Heidi Tsang, RN    +61294631340 ext 31340    heidi.tsang@health.nsw.gov.au   
Principal Investigator: Dasantha Jayamanne, MBBS/FRANZCR         
Sponsors and Collaborators
Royal North Shore Hospital
University of Sydney
Investigators
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Principal Investigator: Dasantha Jayamanne, MD Royal North Shore Hospital
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Responsible Party: Dasantha Jayamanne, Radiation Oncologist, Royal North Shore Hospital
ClinicalTrials.gov Identifier: NCT04310891    
Other Study ID Numbers: VALKIM
First Posted: March 17, 2020    Key Record Dates
Last Update Posted: June 3, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dasantha Jayamanne, Royal North Shore Hospital:
Lung Cancer
Radiotherapy
Fiducials
Markerless Tumour Tracking
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases