Improved Therapy Response Assessment in Metastatic Brain Tumors

Sponsor
Oslo University Hospital
Study ID
NCT03458455
Status
Unknown

Conditions

  • Brain Metastases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Magnetic Resonance Imaging — DIAGNOSTIC_TEST
    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.
  • Stereotactic Radiosurgery — RADIATION
    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.
  • Ipilimumab, nivolumab or pembrolizumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Mar 1, 2013
Status verified
Oct 2023
Primary completion
Jul 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: A
    Patients with brain metastases from non-small cell lung cancer receiving stereotactic radiosurgery to selected lesions
  • Arm: B
    Patients with brain metastases from malignant melanoma receiving stereotactic radiosurgery to selected lesions
  • Arm: C
    Patients with brain metastases from non-small cell lung cancer receiving stereotactic radiosurgery to selected lesions + nivolumab or pembrolizumab
  • Arm: D
    Patients with brain metastases from malignant melanoma receiving stereotactic radiosurgery to selected lesions + ipilimumab, nivolumab or pembrolizumab
  • Arm: E
    Patients with brain metastases from non-small cell lung cancer receiving stereotactic radiosurgery to selected lesions + epidermal growth factor receptor (EGFR) inhibitors

Primary Outcome Measure

Treatment Response [ Time Frame: 18 months ]

Related Studies