Clinical trial NCT04310891: Markerless Image Guidance Using Intrafraction Kolovoltage X-ray Imaging for Lung Cancer Radiotherapy
Official title: Validation of Markerless Image Guidance Using Intrafraction Kolovoltage X-ray Imaging Using Implanted Fiducials: Phase I Observational Study of Lung Cancer Radiotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Markerless Image Guidance
Intrafraction Kolovoltage X-ray Imaging
Keywords: Lung Cancer
Radiotherapy
Fiducials
Markerless Tumour Tracking
Lead sponsor: Royal North Shore Hospital
Sponsor class: OTHER
Collaborators: name: University of Sydney
First posted: 2020-03-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults \>=18 years with NSCLC

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.

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.

Eligibility 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.

Primary outcomes:
measure: Markerless Tumour Tracking
timeFrame: 6 months after recruitment
Secondary outcomes:
measure: Markerless Tumour Tracking outcome
timeFrame: 6 months after treatment of last fraction
measure: Accuracy
timeFrame: 6 months after treatment of last fraction
measure: Magnitude
timeFrame: 6 months after treatment of last fraction
measure: Correlation
timeFrame: 6 months after treatment of last fraction
measure: Suitability
timeFrame: 6 months after treatment of last fraction
measure: Frequency
timeFrame: 6 months after treatment of last fraction
measure: Feasibility of outcomes prediction
timeFrame: 6 months after treatment of last fraction
measure: Outcomes
timeFrame: 6 months after treatment of last fraction
measure: Historical
timeFrame: 6 months after treatment of last fraction
measure: Ineligibility
timeFrame: 6 months after treatment of last fraction
measure: Radiomic Features
timeFrame: 6 months after treatment of last fraction
measure: X-ray dose
timeFrame: 6 months after treatment of last fraction
Other outcomes:
Locations:
city: Saint Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
Study officials:
affiliation: Royal North Shore Hospital
name: Dasantha Jayamanne, MD
role: PRINCIPAL_INVESTIGATOR
References: