Improved Therapy Response Assessment in Metastatic Brain Tumors

Summary

TREATMENT is an observational study addressing the need for knowledge and adequate diagnostic biomarkers in the response assessment of patients with brain metastasis. Reliable response assessment will be highly relevant in the coming years given the introduction of next-generation cancer drugs, including immunotherapy. This project uses advanced Magnetic Resonance Imaging (MRI) and Vessel Architecture Imaging (VAI) to better understand the response to traditional stereotactic radiosurgery (SRS) and immunotherapy.

Secondary objectives include:

In patients with brain metastases, use advanced MRI and Vessel Architectural Imaging methods to reveal parameters of traditional, immunotherapeutic, and anti-angiogenic therapy response.

In patients with brain metastases, use advanced MRI and Vessel Architectural Imaging methods to compare results with traditional biomarkers.

Use existing infrastructure at Oslo University Hospital to standardize therapy monitoring.

In patients with brain metastases, use advanced MRI and Vessel Architectural Imaging methods to separate real tumor progression from treatment-induced pseudoprogression or radionecrosis

In patients with brain metastases, use advanced MRI and Vessel Architectural Imaging methods to assess whether anti-angiogenic drugs improve delivery of chemotherapy.

Conditions

• Brain Metastases

Interventions

DIAGNOSTIC_TEST

Magnetic Resonance Imaging

Vessel Architectural Imaging is an MRI-based tumor diagnostic framework providing a powerful tool for non-invasive, in vivo assessment of diagnostic biomarkers relevant for these new therapy forms; microvascular function and tumor oxygenation.

RADIATION

Stereotactic Radiosurgery

A non-surgical radiation therapy used to treat tumors of the brain. It can deliver precisely-targeted radiation in fewer high-dose treatments than traditional therapy, which can help preserve healthy tissue.

DRUG

Ipilimumab, nivolumab or pembrolizumab

A type of therapy that uses substances to stimulate the immune system to help the body fight cancer by blocking inhibitory receptors on lymphocytes to overcome immune tolerance.

Sponsors & Collaborators

• Hospital of Southern Norway Trust

  collaborator OTHER

• Ostfold Hospital Trust

  collaborator OTHER

• St. Olavs Hospital

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• Dana-Farber Cancer Institute

  collaborator OTHER

• University Medical Center Groningen

  collaborator OTHER

• University of Texas Southwestern Medical Center

  collaborator OTHER

• South-Eastern Norway Regional Health Authority

  collaborator OTHER

• Norwegian Cancer Society

  collaborator OTHER

• Oslo University Hospital

  lead OTHER

Principal Investigators

• Kyrre E Emblem, PhD · Oslo University Hospital

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-03-01

Primary Completion

2024-07-31

Completion

2024-12-31

FDA Drug

Yes

FDA Device

Yes

Countries

• Norway

Study Locations