Karolinska University Hospital
Stockholm, 17176, Sweden
Location status: Recruiting
Location contact
Eva Onjukka, PhD
CONTACT
Mattias Hedman, MD/PhD
CONTACT
NCT Number: NCT06322329
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Stockholm, 17176, Sweden
Location status: Recruiting
Eva Onjukka, PhD
CONTACT
Mattias Hedman, MD/PhD
CONTACT
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Over 3-4 weeks: twice pre-treatment, and three times during treatment
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.
Time frame: Over 3-4 weeks: twice pre-treatment, and three times during treatment
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.
Time frame: Over 3-4 weeks: twice pre-treatment, and three times during treatment
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.
Time frame: Over 3-4 weeks: twice pre-treatment, and three times during treatment
Measured by a questionnaire
Time frame: Up to 10 years after treatment
Review of medical records
Time frame: Up to 10 years after treatment
Review of medical records
Time frame: Up to 10 years after treatment
Review of medical records
Contact information is provided by the study sponsor or research team.
Eva Onjukka, PhD
CONTACT
Mattias Hedman, MD PhD
CONTACT
Region Stockholm
Other Gov
Acronym: RealMove(lung)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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