Stereotactic Body Radiotherapy for Lung Lesions With Markerless Tracking (MLT) on the VERO® SBRT System (SBRT_LOV)

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.

Study Overview

• Status: Withdrawn
• Conditions: Lung Diseases; Lung Cancer; Lung Cancer Metastatic; Lung Cancer, Nonsmall Cell; Stereotactic Body Radiotherapy; Lung Cancer Stage IV
• Intervention / Treatment: Radiation: Standard radiotherapy treatment

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 Type: Observational

Contacts and Locations

Study Locations

• Belgium
  • Brussel, Belgium
    • Universitair Ziekenhuis Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with lung lesions or primary lung cancer

Description

Inclusion Criteria:

1. Primary NSCLC patients, stage T1-2bN0M0 (TNM 8th edition)
2. Oligometastatic patients with ≤ 3 lung metastases; SBRT as a primary treatment or as a consolidative treatment after induction chemotherapy;
3. >= 18 years

4. Patients will be recruited via the treating radiotherapist

   -

   Exclusion Criteria:

   -

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Radiation: 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
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	Radiation: 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
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	Radiation: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival	up to 5 years
Rate of patients treated with markerless and markerbased technique	Comparing patient characteristics between markerbased and marker less technique	1 week
Local tumor control	local control at 1 year	1 year
Number of patients with acute toxicity	according to Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0)	up to 6 months
Number of patients with late toxicity	according to Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0)	up to 5 years
Disease free survival	Disease free survival	up to 5 years

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Investigators: Study Chair: Mark De Ridder, MD, PhD, Universitair Ziekenhuis Brussel; Principal Investigator: Christine Collen, MD, Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2022
• Primary Completion (Estimated): April 30, 2022
• Study Completion (Estimated): April 30, 2022

Study Registration Dates

• First Submitted: May 14, 2019
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Estimated): December 9, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: radiotherapy; stereotactic body radiotherapy; implementation; markerless tracking; clinical feasibility
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Diseases; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: SBRT_LOV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No