NCT04310891Active, not recruiting
Markerless Image Guidance Using Intrafraction Kolovoltage X-ray Imaging for Lung Cancer Radiotherapy
Validation of Markerless Image Guidance Using Intrafraction Kolovoltage X-ray Imaging Using Implanted Fiducials: Phase I Observational Study of Lung Cancer Radiotherapy
Source: ClinicalTrials.gov · Last updated 29 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 5 (actual)
- First submitted
- 12 Mar 2020
- Start date
- 4 Dec 2020
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Royal North Shore Hospital
- Diseases
- Lung cancer
- NCT number
- NCT04310891
What you commit to
- Study type: Observational
- Participants enrolled: 5
- From 4 Dec 2020 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous high-dose thoracic radiotherapy.
- 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, concurrently with treatment or 7 days after radiotherapy.
Other
- Patient has low respiratory performance as evaluated by the physicians.
- Less than one fiducial marker implanted in the lung.
- Fiducial markers are too far from the tumour centroid (\>9 cm).
- Women who are pregnant or lactating.
- Unwilling or unable to give informed consent.
- Unwilling or unable to complete quality of life questionnaires.
Who the study is looking for
- 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.
- Histologically proven Stage I NSCLC or oligometastatic lung metastases (3 or less).
- Diagnostic CT prior to insertion of fiducial markers.
- Patient must be able to have fiducial markers placed in the lung (if on anticoagulants, must be cleared by LMO or cardiologist).
- ECOG performance status 0-2.
- A maximum of three metastases to the lung from any non-haematological malignancy. Multiple metastases will be treated separately.
- 1 cm ≤ Tumour diameter in any dimension ≤ = 5 cm.
- The distance between the tumour centroid and the top end of the diaphragm is \<=8 cm.
Age in the registry: 18 years to 80 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal North Shore Hospital Coordinator of this site? Confirm its status | Saint Leonards | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.