Pelvic and Para-aortic Lymph Node MetastasesMACULANCT07083648
Magnetic Resonance Imaging-guided Online Adaptive Radiotherapy of Pelvic Lymph Node Metastases
A study testing Magnetic resonance Imaging-guided online adaptive radiotherapy in people with Pelvic and Para-aortic Lymph Node Metastases, run by University of Zurich at 1 site in Switzerland.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pelvic and Para-aortic Lymph Node Metastases
- What is being tested?
- Magnetic resonance Imaging-guided online adaptive radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Jul 2025to 26 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Zurich University Hospital, Department of Radiation Oncology
Zurich, Canton of Zurich, 8091
About this study
Official title: Magnetic Resonance Imaging-guided Online Adaptive Radiotherapy Using a Dedicated MR-simulator and a Cone Beam CT Based Treatment Delivery for Stereotactic Body Radiation Therapy of Pelvic Lymph Node Metastases (MACULA-Trial)
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.
- Being tested
- Magnetic resonance Imaging-guided online adaptive radiotherapy
- Keywords
- pelvic, lymph node, para-aortic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance Imaging-guided online adaptive radiotherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| MR-guided online adaptive RT using a dedicated MR-simulator and cone-beam CT (CBCT)-based treatment | Experimental | Not described Receives: Radiation: Magnetic resonance Imaging-guided online adaptive radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during treatment, 1-2 weeks
Secondary outcomes (2)
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).
Measured: During treatment, 1-2 weeks
Adverse Events
Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
Measured: during SBRT, 3 months and 24 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start16 Jul 2025
- Primary completion26 Jan 2026
- Study completion26 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic and Para-aortic Lymph Node MetastasesStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083648
- Sponsor's protocol ID
- RAO-24-017
- Acronym
- MACULA
- Status last verified
- May 2026
- First submitted
- 3 Jul 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging-guided Online Adaptive Radiotherapy Using a Dedicated MR-simulator and a Cone Beam CT Based Treatment Delivery for Stereotactic Body Radiation Therapy of Pelvic Lymph Node Metastases (MACULA-Trial)
- ClinicalTrials.gov ID
- NCT07083648
- Acronym / sponsor ID
- MACULA / RAO-24-017
- Keywords
- pelvic, lymph node, para-aortic
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- 26 Jan 2026 (actual)
- Study completion
- 26 Jan 2028 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MR-guided online adaptive RT using a dedicated MR-simulator and cone-beam CT (CBCT)-based treatment | Experimental | Radiation: Magnetic resonance Imaging-guided online adaptive radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- Large body size that would not fit the MRI-simulator bore;
- Contraindications for MRI including but not limited to
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic resonance Imaging-guided online adaptive radiotherapyOn 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. | Radiation | MR-guided online adaptive RT using a dedicated MR-simulator and cone-beam CT (CBCT)-based treatment |
Primary outcome
Rate of successfully delivered fractions
Time frame: during treatment, 1-2 weeks
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.
2 secondary outcomes
Average improvement of coverage of planning target volume
Time frame: During treatment, 1-2 weeks
Adverse Events
Time frame: during SBRT, 3 months and 24 months of follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic resonance Imaging-guided online adaptive radiotherapy in people with Pelvic and Para-aortic Lymph Node Metastases, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of successfully delivered fractions (time frame: during treatment, 1-2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.