NCT06322329

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
120mo left

Started Mar 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Mar 2024Mar 2036

First Submitted

Initial submission to the registry

March 8, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

March 15, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 21, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2026

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2036

Expected
Last Updated

September 2, 2025

Status Verified

April 1, 2025

Enrollment Period

2 years

First QC Date

March 8, 2024

Last Update Submit

August 25, 2025

Conditions

Lung Tumor

Keywords

RadiotherapyMotion managementDynamic MRI

Outcome Measures

Primary Outcomes (3)

  • Difference in amplitude of the tumour motion, as assessed by dynamic MRI and 4D CT, respectively

    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.

    Over 3-4 weeks: twice pre-treatment, and three times during treatment

  • Difference in amplitude of the tumour motion, assessed at different times (using dynamic MRI and 4D CBCT)

    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.

    Over 3-4 weeks: twice pre-treatment, and three times during treatment

  • Difference in the structure of the probability density function, assessed at different times

    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.

    Over 3-4 weeks: twice pre-treatment, and three times during treatment

Secondary Outcomes (4)

  • Anxiety during examinations of tumour motion

    Over 3-4 weeks: twice pre-treatment, and three times during treatment

  • Overall survival

    Up to 10 years after treatment

  • Progression-free survival

    Up to 10 years after treatment

  • Grade ≥2 toxicity assessed by CTCAE v.5.0

    Up to 10 years after treatment

Study Arms (1)

Full cohort

EXPERIMENTAL

All subjects are included in the same arm.

Other: Dynamic MRI

Interventions

Dynamic MRIOTHER

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.

Full cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Accepted for SBRT treatment of one or more caudally situated lung targets (NSCLC or metastases), i.e. below the carina.
  • Age ≥ 18 years
  • Adequate clinical condition to maintain immobilised position for at least 30 minutes
  • Adequate Swedish skills and cognitive function to understand study information and to fill in the questionnaire

You may not qualify if:

  • Pregnancy or breastfeeding, or planned pregnancy or breastfeeding, during treatment
  • Contraindication for MRI examination
  • Otherwise incapable of participating in study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Eva Onjukka, PhD

    Karolinska University Hospital/Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mattias Hedman, MD PhD

CONTACT

+46812370000mattias.hedman@regionstockholm.se

Eva Onjukka, PhD

CONTACT

eva.onjukka@ki.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2024

First Posted

March 21, 2024

Study Start

March 15, 2024

Primary Completion

March 17, 2026

Study Completion (Estimated)

March 17, 2036

Last Updated

September 2, 2025

Record last verified: 2025-04

Locations

SE(1)