Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Respiratory motion causes significant geometric and dosimetric errors in the administration of lung stereotactic radiotherapy (SBRT). The purpose of this study is to create and validate patient-specific motion models of the thoracic anatomy with high spatial and temporal resolution. These models will be used to develop novel four-dimensional (4D=3D+time) techniques for radiotherapy treatment planning and real-time motion-adaptive dose delivery.

Amit Sawant, PhD

Real-time optical surface monitoring data will be acquired from 44 human patients with primary or metastatic lung lesions during and after their 4DCT scan (standard-of-care at our institution). A patient-specific 4D model will be developed using the raw 4DCT projections time-correlated with real-time surface monitoring. In addition, before delivering each dose fraction (3 - 5 for lung SBRT), we will acquire three 15s kV fluoroscopic image acquisitions, time-correlated with optical surface monitoring. The acquisitions will be distributed over three well-spaced beam angles, e.g., every 4th angle for a 12-field plan.

Surface monitoring procedure -The procedure is expected to last approximately 15 minutes after the end of the 4DCT scan, which is the standard-of-care for lung SBRT treatments at our institution. The procedure will consist of real-time surface tracking using the VisionRT system of the thoracic and/or abdominal region. Continuous audiovisual contact will be maintained with the subject during scanning. Each individual will be informed that they can stop the procedure at any point.

Fluoroscopic imaging procedure - Fluoroscopic imaging will be performed in the treatment room with the patient lying in treatment position. Three 15s acquisitions will be performed under free breathing conditions, each from a different beam angle, using the on-board kV imager. Audiovisual contact will be maintained at all times with the patient.

Data collection and management: An ID number will be assigned to each separate patient, and the correlation between ID number and patient name and medical record number will be kept in a password-protected file in Dr. Amit Sawant's office. The database of information extracted from the medical record and radiation treatment records for each patient will be stored in an Excel file on a computer with password protection. All image data will be de-identified by Dr. Sawant before his research team analyzes them.

Lung SBRT Motion Management (GCC 1619)

Modeling Respiration-induced Motion and Deformation of Tumors and Thoracic Organs for Personalized Motion Management in Lung SBRT

Develop novel Four-dimensional (4D=3D+time) techniques for radiotherapy treatment planning and real-time motion-adaptive dose delivery.

University of Maryland

University of Maryland, Baltimore

Principal Investigator

All subjects are included in the same arm.

Subjects receive a study-specific dynamic MRI scan. If the hypothesis of the study is confirmed, this examination can be used to inform future patients' treatment planning, replacing the use of 4D CT.

Dynamic MRI

Mattias Hedman, MD PhD

Eva Onjukka, PhD

Mattias Hedman, MD/PhD

The study aims to develop an improved method to tailor the geometric safety margin when treating with stereotactic body radiotherapy (SBRT), to avoid tumour cells being missed during irradiation and to limit the exposure of normal tissues as much as possible. Dynamic magnetic resonance imaging (MRI) is assumed to represent the tumour motion during the respiratory cycle more realistically, compared to 4-dimensional computed tomography (4D CT), thanks to its high temporal resolution and the possibility to image the motion over a longer period of time. Patients receiving SBRT for a pulmonary target located below the level of the carina are included in the study, and the hypothesis will be tested through a comparison of the tumour amplitude measured with each modality. Furthermore, the predictive value of the image series acquired at treatment planning, for the motion patterns observed at each treatment fraction, will be evaluated through repeated 4D CBCT acquisitions.

In the current study, a 2D-cine MRI examination will be performed, in addition to the 4D CT examination that is standard for patients receiving radiotherapy for tumours in the thorax or abdomen. A subgroup of the study participants (referred to as the 4D CBCT subcohort) will also be required to perform a 4D CBCT examination at three treatment sessions. The main cohort consists of 95 subjects and the 4D CBCT subcohort of 55 subjects. The study does not involve any change in the treatment routine; rather, the study images are collected for retrospective analysis. Following each imaging session, the subject should fill out an anxiety questionnaire and their pulse will be measured, to give an indication of any anxiety which might influence the breathing pattern of the current session.

Clinical follow-up will be performed retrospectively by reviewing the participants' medical records. Progress, health status and treatment-related toxicity will be evaluated, up to 10 years after completed treatment.

The study objectives are:

* To evaluate dynamic MRI for characterising the respiratory-related tumour motion, compared to the current standard modality of 4D CT.
* To evaluate the variation in breathing motion at different times points.
* To evaluate the clinical outcome.

RealMove (Lung): Assessing Tumour Motion With Dynamic MRI

The two dynamic scans represent the tumour motion through different techniques. If the amplitude indicated by 4D CT is smaller than that indicated by dynamic MRI, the hypothesis is confirmed.

4D CBCT images are acquired at each treatment session, in treatment position. These will assess the stability of the breathing patter through the treatment course.

The breathing pattern is represented by a probability density function, indicating the regularity of the motion. The stability of this pattern through the treatment course will be assessed.

Uppsala University Hospital

Region Stockholm

Digestive System Diseases

Liver Neoplasms

Dynamic MRI acquisition will be performed at two different time points with 10 healthy volunteers under non-invasive mechanically-assisted ventilation with a respirator. Different modes will be compared (spontaneous, physiologic, shallow, slow and jet ventilation).

Dynamic MRI acquisition will be performed at two different time points with 10 patients (intended for a radiation treatment of their thoracic or upper abdominal tumours) under non-invasive mechanically-assisted ventilation with a respirator. Different modes will be compared (spontaneous, physiologic, shallow, slow and jet ventilation).

Planning 4D-CT will be performed with 10 patients (intended for a radiation treatment of their thoracic or upper abdominal tumours) under non-invasive mechanically-assisted ventilation with a respirator. Different ventilation modes will be compared (spontaneous, physiologic, shallow, slow and jet ventilation).

Mechanically ventilation will be done through facial masks connected to a respirator. Volunteers/patients are fully conscious during the ventilation.

Non-invasive mechanically-assisted ventilation

Dynamic MRI acquisition are specific dynamic sequences intended to visualise the motion of internal structures (anatomical structures or tumour) under non-invasive mechanically-assisted ventilation

Dynamic MRI acquisition

In order to perform in-silico planning, 4D-CT will be acquired on patients under non-invasive mechanically-assisted ventilation

Planning 4D-CT

Xavier Geets, MD, PhD

Mechanical ventilation can be used to impose a completely regular pattern of breathing frequency and inflation volume on the patient for as long as required. This would considerably improve the reproducibility of the internal motion parameters, and thus facilitate the implementation of respiratory-synchronized techniques such as gating, tracking and four-digital optimization.

This will be a three-phase analysis :

First, different ventilation modes will be tested and compared on healthy volunteers. This phase will be analysed with a ventilator and with dynamic MRI in order to measure the movement of anatomical structures in each ventilation mode (intra-fraction analysis). Further, we will repeat these exams in order to compare them with the first ones, in order to analyse the reproducibility and baseline shifts (inter-fraction analysis).

Here are the different ventilation modes

* spontaneous breathing
* physiologic ventilation mode :
* shallow ventilation mode
* slow ventilation mode
* Jet Ventilation mode

Second phase will be done with patients that are intended to have a radiation treatment for thoracic or upper abdominal tumors. All the previous ventilation modes will be analysed during repeated MRI, again in order to perform intra- and inter-fraction analysis of the tumor motion.

Third phase also concerned patients intended to have a radiation treatment. It will be an in-silico-planning analysis in order to quantify dosimetric outcomes of these ventilation modes.

One group of patients with healthy volunteers and two groups with lung/upper abdomen cancer patients

Mechanically-assisted Ventilation in the Treatment of Moving Tumours With Photon and Proton Therapies

Added Value of Mechanically-assisted Ventilation in the Treatment of Moving Tumours (Thoracic/Upper Abdomen) With Photon and Proton Therapies.

This analysis will be based on dynamic MRI analysis made with healthy volunteers and also patients on non-invasive mechanically assisted ventilation. A well defined anatomical structure will be selected for the healthy volunteers while the tumor will be tracked in patients.

During all these acquisitions, the tolerance to the non-invasive mechanically assisted ventilation will be assessed by all the participants through a 5-steps scale.

This analysis will be done by comparing the motion of the internal structures/tumors at two different time points (MRI acquisition at two different time points). All these acquisitions will obviously be done in the same conditions on non-invasive mechanically assisted ventilation. Motion reproducibility will be analysed by comparing the baseline positions of anatomical structures/tumors on MRI images and the measures in millimeters of motion of the same anatomical structures/tumors.

This dosimetric comparison will be done in order to assess the impact of non-invasive mechanically-assisted ventilation on dose planning and delivery. Difference in dose (in Gy) to organ at risks will specially be compared through the DVH (dose-volume histogram) analysis.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Lung SBRT Motion Management (GCC 1619)	NCT02695680	Lung Cancer		18 Years -	University of Maryland, Baltimore
RealMove (Lung): Assessing Tumour Motion With Dynamic MRI	NCT06322329	Lung Tumor	Dynamic MRI	18 Years -	Region Stockholm
RealMove (Lung): Assessing Tumour Motion With Dynamic MRI	NCT06322329	Lung Tumor	Dynamic MRI	18 Years -	Region Stockholm
Lung SBRT Motion Management (GCC 1619)	NCT02695680	Lung Cancer		18 Years -	University of Maryland, Baltimore
Mechanically-assisted Ventilation in the Treatment of Moving Tumours With Photon and Proton Therapies	NCT03226925	Thoracic Neopla... Liver Cancer Ventilator Lung Radiotherapy; C...	Non-invasive me... Dynamic MRI acq... Planning 4D-CT	18 Years -	Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Spots Global Cancer Trial Database for motion management