ioMRI in the Surgery of Brain Metastases.

NCT07197632 | Recruiting

• 1 other identifier: 2024-452-S-KK Votum 12.12.2024
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to improve the surgical treatment of brain metastases through the use of advanced imaging techniques. The investigators are examining how intraoperative MRI (iMRI) can aid surgeons in precisely locating and removing tumors, with the potential to enhance surgical outcomes and reduce the need for additional procedures. While iMRI offers the promise of better tumor visualization during surgery, it is also associated with longer surgical times and may carry the risk of increased complications. This study seeks to carefully evaluate these aspects to determine the overall benefits and challenges of iMRI in brain metastasis surgeries. The ultimate aim is to enhance treatment effectiveness and improve recovery and health outcomes for participants dealing with brain metastases.

Conditions

Brain Metastases

Keywords

ioMRI; Brain metastases; Neurosurgical resection

Outcome Measures

Primary Outcomes (1)

• Rate for complete resection

  The postoperative MRI obtained within 72 hours after surgery will be analyzed to identify the rates of resection.

  immediately after the surgery

Secondary Outcomes (1)

• Complications

  Perioperatively

Other Outcomes (1)

• Overall survival

  Through study completion, an average of 2 years

Study Arms (2)

Surgery without intraoperative MRI

NO INTERVENTION

Surgery with intraoperative MRI

EXPERIMENTAL

Procedure: Surgery with intraoperative MRI

Interventions

Surgery with intraoperative MRI PROCEDURE

In this clinical study, we have the unique opportunity to utilize a 3 Tesla MRI intraoperatively during the surgical resection of brain metastases. This approach is distinctly different from standard procedures and offers several advantages. The use of a 3 Tesla MRI provides high-resolution imaging during surgery, offering unparalleled detail of brain structures and tumor boundaries. This level of imaging precision is typically not available in standard surgical procedures. Through real-time visualization, surgeons can better differentiate between tumor tissue and healthy brain tissue, potentially increasing the accuracy of tumor removal and minimizing damage to surrounding areas. Unlike conventional methods, this procedure allows for immediate intraoperative imaging feedback, enabling surgical teams to adjust their techniques dynamically

Surgery with intraoperative MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients for whom surgical resection of brain metastasis is indicated

You may not qualify if:

• age \< 18
• T MRI contraindications

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Department of Neurosurgery, München University Hospital rechts der Isar (MRI)

Munich, 81675, Germany

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Maria Goldberg

CONTACT

+498941402151; maria.goldberg@tum.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2025
• First Posted: September 29, 2025
• Study Start: January 17, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2030
• Last Updated: May 5, 2026

Record last verified: 2026-05

Locations

DE (1)