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

NCT ID: NCT06722885

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-04-30

Brief Summary

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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

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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

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Lung Cancer Stereotactic Body Radiotherapy Lung Diseases Lung Cancer Metastatic Lung Cancer Stage IV Lung Cancer, Nonsmall Cell

Keywords

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radiotherapy stereotactic body radiotherapy markerless tracking clinical feasibility implementation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Standard radiotherapy treatment

Intervention Type RADIATION

* 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

Standard radiotherapy treatment

Intervention Type RADIATION

* 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

Standard radiotherapy treatment

Intervention Type RADIATION

* 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

Interventions

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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

Intervention Type RADIATION

Eligibility Criteria

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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

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Exclusion Criteria

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Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Mark De Ridder

Prof Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mark De Ridder, MD, PhD

Role: STUDY_CHAIR

Universitair Ziekenhuis Brussel

Christine Collen, MD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Locations

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Universitair Ziekenhuis Brussel

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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SBRT_LOV

Identifier Type: -

Identifier Source: org_study_id