CClinicalTrials.gg
Active, not recruitingNCT07083648MACULAUpdated May 11, 2026

Magnetic Resonance Imaging-guided Online Adaptive Radiotherapy of Pelvic Lymph Node Metastases

An interventional study of Magnetic resonance Imaging-guided online adaptive radiotherapy in Pelvic and Para-aortic Lymph Node Metastases, sponsored by University of Zurich. Active, not recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-11.

Sponsored by University of Zurich · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

In this study, the investigators want to investigate whether online-adapted radiotherapy using a special magnetic resonance imaging (MRI) simulator and computed tomography (CT)-guided radiation therapy, is feasible and offers advantages for the treatment of pelvic lymph node metastases.

Read the detailed description

MR-guided online adaptive radiotherapy has been implemented recently using MR-linac technology, where MR-imaging is combined with linac technology in hybrid systems. These systems offer MR imaging for online adaptive radiotherapy (RT) within the treatment room and with the patient in treatment position. Despite results regarding technical and clinical feasibility being promising, the high costs of MR-linacs systems and the high demands for staffing resources of MR-linacs are limiting a boarder implementation of this technology. At the Department of Radiation Oncology, University Hospital Zurich, MRI-simulations for RT planning using a dedicated scanner have been performed since 2023. The investigators have developed and implemented an MRI-only RT planning workflow followed by RT delivered at a CBCT-guided, conventional linac. The aim to expand the MRI-only workflow to online adaptive RT. This study will investigate the feasibility of MRI-guided, online adaptive SBRT for pelvic and para-aortic lymph node metastases using a dedicated MR simulator and treatment delivery using conventional CBCT-linac technology.

02

Conditions studied

  • Pelvic and Para-aortic Lymph Node Metastases

Keywords

  • pelvic
  • lymph node
  • para-aortic
03

In context

Lead sponsor

University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Intra-pelvic and para-aortic lymph node metastases from a histologically confirmed malignancy;
  • Indication for SBRT based on a multidisciplinary tumor board recommendation and / or clinical practice guideline;
  • Intra-pelvic and para-aortic lymph node metastases confirmed by imaging and amenable for SBRT

Exclusion criteria

Exclusion Criteria:

  • Large body size that would not fit the MRI-simulator bore;
  • Contraindications for MRI including but not limited to

    • electronic devices such as pacemakers, defibrillators, deep brain stimulators, cochlear implants that are labeled as MR unsafe. Electronic devices labeled as MR safe or MR conditional are not a contraindication;
    • metallic foreign body in the eye or aneurysm clips in the brain;
    • severe claustrophobia;
    • hip prosthesis that are labeled as MR unsafe;
  • More than 5 pelvic lymph node metastasis
  • Previous radiation therapy directly overlapping with SBRT in this study and leading to exceeding tolerance of OARs;
  • History of Crohn's disease, ulcerative colitis
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    MR-guided online adaptive RT using a dedicated MR-simulator and cone-beam CT (CBCT)-based treatment

    Radiation: Magnetic resonance Imaging-guided online adaptive radiotherapy

Interventions

  • RadiationMagnetic resonance Imaging-guided online adaptive radiotherapy

    On each day of treatment, a new MRI scan in the treatment position will be acquired using the dedicated MR simulator, co-registered with the original one. The original target and organ at risk (OAR) contours will be propagated to the new image set using rigid and deformable image registration. The contours will be adapted to changes detected with MRI of the day. The original SBRT treatment plan will be adapted to the changed and hence adapted anatomy of targets and OARs by plan optimization. Dose calculation will be performed on the newly generated synthetic CT (preferred) or, if there is a contra-indication for synthetic CT, on the original image.

06

What researchers measure

Primary outcomes

  1. Rate of successfully delivered fractions

    Feasibility is measured as a successful delivery of an MRI-adapted plan using CBCT image-guidance in another room in 90% of the SBRT fractions.

    Time frame: during treatment, 1-2 weeks

Secondary outcomes

  1. Average improvement of coverage of planning target volume

    Dosimetric advantage is defined as \>5% improvement in coverage of the planning target volume (PTV) or \>5% better sparing of one of the organs at risk (bowel, sigma , rectum, bladder).

    Time frame: During treatment, 1-2 weeks

  2. Adverse Events

    Common Terminology Criteria for Adverse Events (CTCAE), version 5.0

    Time frame: during SBRT, 3 months and 24 months of follow-up

07

Study locations

1 site
  • Zurich University Hospital, Department of Radiation Oncology
    Zurich, Canton of Zurich 8091, Switzerland
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07083648
Lead sponsor
University of Zurich
Responsible party
Sponsor
First posted
Jul 24, 2025
Start date
Jul 16, 2025
Primary completion
Jan 26, 2026
Completion
Jan 26, 2028 (estimated)
Last update
May 11, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion