Lung CancerSBRT_LOVNCT06722885
Stereotactic Body Radiotherapy for Lung Lesions With Markerless Tracking (MLT) on the VERO® SBRT System
An observational study of Lung Cancer and Stereotactic Body Radiotherapy, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
Stereotactic Body Radiotherapy (SBRT) delivers an ablative dose of radiation to tumours, with high precision. This technique offers an alternative to surgery for lung lesions. The UZ Brussel of the VUB developed with the support of the Hercules foundation (grant for heavy research infrastructure) in collaboration with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Stereotactic Body Radiotherapy, Lung Diseases
- What is being tested?
- Standard radiotherapy treatment
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2022to 30 Apr 2022
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with lung lesions or primary lung cancer
Who may be able to join
- Primary NSCLC patients, stage T1-2bN0M0 (TNM 8th edition)
- Oligometastatic patients with ≤ 3 lung metastases; SBRT as a primary treatment or as a consolidative treatment after induction chemotherapy;
- >= 18 years
- Patients will be recruited via the treating radiotherapist
- -
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study of Stereotactic Body Radiotherapy for Lung Lesions With Markerless Tracking (MLT) on the VERO® SBRT System
Stereotactic Body Radiotherapy (SBRT) delivers an ablative dose of radiation to tumours, with high precision. This technique offers an alternative to surgery for lung lesions. The UZ Brussel of the VUB developed with the support of the Hercules foundation (grant for heavy research infrastructure) in collaboration with Brainlab AG a breathing-synchronized radiation technique on the VERO SBRT system, where the radiation beam follows the moving target (dynamic tumour tracking). The implantation of a marker in the tumour is thereby mandatory for its visualization but excluding patients with poor pulmonary function. Therefore Brainlab® recently released an update of the VERO SBRT system that allows "Markerless Tracking". This markerless technique is currently being implemented at the Radiotherapy Department of UZ Brussel for lung lesions. Hence we plan an observational study that will document the outcome of and feasibility for patients with lung lesions treated with markerless tracking on the VERO SBRT system at the Radiotherapy Department in UZ Brussel.
Read the detailed description
Stereotactic Body Radiotherapy (SBRT) delivers an ablative dose of radiation to tumours, with high precision. This technique offers an alternative to surgery for lung lesions. The movement of these tumours represents a clinical problem and a technological challenge. The UZ Brussel of the VUB developed with the support of the Hercules foundation (grant for heavy research infrastructure) in collaboration with Brainlab AG a breathing-synchronized radiation technique on the VERO SBRT system, where the radiation beam follows the moving target (dynamic tumour tracking). The implantation of a marker in the tumour is thereby mandatory for its visualization but excluding patients with poor pulmonary function. Moreover, the placement of such an implanted fiducial marker is contraindicated for about 30% of the patients and may be associated with complications such as pneumothorax and bleeding.
Therefore Brainlab® recently released an update of the VERO SBRT system that allows "Markerless Tracking" (MLT). This markerless technique is currently being implemented at the Radiotherapy Department of UZ Brussel for lung lesions. Within the Spearhead Strategic Research Program "Societal Benefit of Markerless Stereotactic Body Radiotherapy: a Statistical Support based on Quantitative Imaging", the investigators aim at evaluating the implementation of this technique focusing on patient outcomes and clinical feasibility. In order to do so they plan an observational study that will document the feasibility and outcome of patients with lung lesions treated with markerless tracking on the VERO SBRT system at the Radiotherapy Department in UZ Brussel.
- Conditions
- Lung Cancer, Stereotactic Body Radiotherapy, Lung Diseases, Lung Cancer Metastatic, Lung Cancer Stage IV, Lung Cancer, Nonsmall Cell
- Being tested
- Standard radiotherapy treatment
- Keywords
- radiotherapy, stereotactic body radiotherapy, markerless tracking, clinical feasibility, implementation
- Medical subject headings
- Lung Neoplasms, Lung Diseases, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard radiotherapy treatmentRadiation
- 3 x 17 Gy for peripheral NSCLC
- 4 x 12 Gy in centrally located NSCLC or at < 1cm from the thoracic wall
- 8 x 7,5 Gy if with the predefined dose for NSCLC, the constraints of the organs at risk cannot be met
- 5 x 8,5 Gy in case of oligometastases
| Study group | Role | What they receive |
|---|---|---|
| Markerless tracking | * Gross tumor volume for MLT (GTV_MLT): lesion delineated on stable exhale phase of the 4DCT.
* Planning target volume for MLT (PTV_MLT): GTV + 8 mm isotropic expansion Receives: Radiation: Standard radiotherapy treatment | |
| ITV approach | * Gross tumor volume (GTV): lesion delineated on the ten phases of the 4DCT.
* Internal target volume (ITV): propagate all GTV on stable exhale phase of the 4DCT.
* Planning target volume for ITV (PTV_ITV): ITV + 5 mm isotropic expansion Receives: Radiation: Standard radiotherapy treatment | |
| Markerbased tracking | * Gross tumor volume for tracking (GTV_Track): lesion delineated on stable exhale phase of the 4DCT.
* Planning target volume for tracking (PTV_Track): GTV + 5 mm isotropic expansion Receives: Radiation: Standard radiotherapy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients treated with markerless and markerbased technique
Comparing patient characteristics between markerbased and marker less technique
Measured: 1 week
Local tumor control
local control at 1 year
Measured: 1 year
Number of patients with acute toxicity
according to Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0)
Measured: up to 6 months
Number of patients with late toxicity
according to Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0)
Measured: up to 5 years
Disease free survival
Disease free survival
Measured: up to 5 years
Overall survival
Overall survival
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start1 Jan 2022 (estimated)
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Why it stopped: The VERO® SBRT System radiation machine had water damage and could not be repaired.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark De Ridder, Universitair Ziekenhuis Brussel
- Investigators
- Mark De Ridder, MD, PhD, Study chair, Universitair Ziekenhuis BrusselChristine Collen, MD, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722885
- Sponsor's protocol ID
- SBRT_LOV
- Acronym
- SBRT_LOV
- Status last verified
- Dec 2024
- First submitted
- 14 May 2019
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Stereotactic Body Radiotherapy for Lung Lesions With Markerless Tracking (MLT) on the VERO® SBRT System
- ClinicalTrials.gov ID
- NCT06722885
- Acronym / sponsor ID
- SBRT_LOV / SBRT_LOV
- Conditions
- Lung Cancer, Stereotactic Body Radiotherapy, Lung Diseases, Lung Cancer Metastatic, Lung Cancer Stage IV, Lung Cancer, Nonsmall Cell
- Keywords
- radiotherapy, stereotactic body radiotherapy, markerless tracking, clinical feasibility, implementation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The VERO® SBRT System radiation machine had water damage and could not be repaired.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stereotactic Body Radiotherapy (SBRT) delivers an ablative dose of radiation to tumours, with high precision. This technique offers an alternative to surgery for lung lesions. The UZ Brussel of the VUB developed with the support of the Hercules foundation (grant for heavy research infrastructure) in collaboration with Brainlab AG a breathing-synchronized radiation technique on the VERO SBRT system, where the radiation beam follows the moving target (dynamic tumour tracking). The implantation of a marker in the tumour is thereby mandatory for its visualization but excluding patients with poor pulmonary function. Therefore Brainlab® recently released an update of the VERO SBRT system that allows "Markerless Tracking". This markerless technique is currently being implemented at the Radiotherapy Department of UZ Brussel for lung lesions. Hence we plan an observational study that will document the outcome of and feasibility for patients with lung lesions treated with markerless tracking on the VERO SBRT system at the Radiotherapy Department in UZ Brussel.
Detailed description
Stereotactic Body Radiotherapy (SBRT) delivers an ablative dose of radiation to tumours, with high precision. This technique offers an alternative to surgery for lung lesions. The movement of these tumours represents a clinical problem and a technological challenge. The UZ Brussel of the VUB developed with the support of the Hercules foundation (grant for heavy research infrastructure) in collaboration with Brainlab AG a breathing-synchronized radiation technique on the VERO SBRT system, where the radiation beam follows the moving target (dynamic tumour tracking). The implantation of a marker in the tumour is thereby mandatory for its visualization but excluding patients with poor pulmonary function. Moreover, the placement of such an implanted fiducial marker is contraindicated for about 30% of the patients and may be associated with complications such as pneumothorax and bleeding.
Therefore Brainlab® recently released an update of the VERO SBRT system that allows "Markerless Tracking" (MLT). This markerless technique is currently being implemented at the Radiotherapy Department of UZ Brussel for lung lesions. Within the Spearhead Strategic Research Program "Societal Benefit of Markerless Stereotactic Body Radiotherapy: a Statistical Support based on Quantitative Imaging", the investigators aim at evaluating the implementation of this technique focusing on patient outcomes and clinical feasibility. In order to do so they plan an observational study that will document the feasibility and outcome of patients with lung lesions treated with markerless tracking on the VERO SBRT system at the Radiotherapy Department in UZ Brussel.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Markerless tracking | – | Radiation: Standard radiotherapy treatment* Gross tumor volume for MLT (GTV_MLT): lesion delineated on stable exhale phase of the 4DCT. * Planning target volume for MLT (PTV_MLT): GTV + 8 mm isotropic expansion |
| ITV approach | – | Radiation: Standard radiotherapy treatment* Gross tumor volume (GTV): lesion delineated on the ten phases of the 4DCT. * Internal target volume (ITV): propagate all GTV on stable exhale phase of the 4DCT. * Planning target volume for ITV (PTV_ITV): ITV + 5 mm isotropic expansion |
| Markerbased tracking | – | Radiation: Standard radiotherapy treatment* Gross tumor volume for tracking (GTV_Track): lesion delineated on stable exhale phase of the 4DCT. * Planning target volume for tracking (PTV_Track): GTV + 5 mm isotropic expansion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with lung lesions or primary lung cancer
Key inclusion criteria (5 listed)
- Primary NSCLC patients, stage T1-2bN0M0 (TNM 8th edition)
- Oligometastatic patients with ≤ 3 lung metastases; SBRT as a primary treatment or as a consolidative treatment after induction chemotherapy;
- >= 18 years
- Patients will be recruited via the treating radiotherapist
- -
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard radiotherapy treatment* 3 x 17 Gy for peripheral NSCLC * 4 x 12 Gy in centrally located NSCLC or at < 1cm from the thoracic wall * 8 x 7,5 Gy if with the predefined dose for NSCLC, the constraints of the organs at risk cannot be met * 5 x 8,5 Gy in case of oligometastases | Radiation | ITV approach, Markerbased tracking, Markerless tracking |
Primary outcome
Rate of patients treated with markerless and markerbased technique
Time frame: 1 week
Comparing patient characteristics between markerbased and marker less technique
Local tumor control
Time frame: 1 year
local control at 1 year
Number of patients with acute toxicity
Time frame: up to 6 months
according to Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0)
Number of patients with late toxicity
Time frame: up to 5 years
according to Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0)
Disease free survival
Time frame: up to 5 years
Disease free survival
Overall survival
Time frame: up to 5 years
Overall survival
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark De Ridder, MD, PhD study chair
Universitair Ziekenhuis Brussel
Christine Collen, MD principal investigator
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Stereotactic Body Radiotherapy, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients treated with markerless and markerbased technique (time frame: 1 week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.