Improved Therapy Response Assessment in Metastatic Brain Tumors (TREATMENT)

October 31, 2023 updated by: Kyrre Eeg Emblem, Oslo University Hospital

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0424
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Both men and women of all races and ethnic groups are eligible for this trial.

Cohort A: Accrual of up to 55 patients with brain metastases from NSCLC may be required in order to achieve 50 evaluable patients.

Cohort B: Accrual of up to 33 patients with brain metastases from malignant melanomas may be required in order to achieve 30 evaluable patients.

Cohort C: Accrual of up to 55 patients with brain metastases from malignant melanomas may be required in order to achieve 50 evaluable patients.

Cohort D: Accrual of up to 33 patients with brain metastases from malignant melanomas may be required in order to achieve 30 evaluable patients.

Cohort E: Accrual of up to 22 patients with brain metastases from malignant melanomas may be required in order to achieve 20 evaluable patients.

Description

Inclusion Criteria:

  • Participants must have histologically - or - radiographically confirmed metastatic disease from a primary non-small-cell lung cancer - or - metastatic melanoma.
  • Participants must have measurable disease in the central nervous system (CNS), defined as at least one lesion that can be accurately measured in at least one dimension as ≥5 mm with MRI - or - compromise more than 30 image voxels on perfusion MRI to ensure adequate parametric statistical assessments. For a perfusion MRI resolution of 1.2x1.2x5mm, this equals a tumor volume of 0.2cubic centimeters (cc).
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1 (Karnofsky ≥60%)
  • Life expectancy of greater than 6 weeks
  • Eligible for stereotactic radiosurgery
  • Have normal organ functions per clinical guidelines
  • Ability to understand and the willingness to sign a written informed consent document.

  • Previously untreated asymptomatic brain metastases - or - progressive brain metastases after systemic therapy or prior local therapy such as radiation or surgery as defined by:

    1. Untreated measurable lesions in patients that have received surgery and/or SRS to one or more other lesions
    2. Residual or progressive lesions after surgery if asymptomatic
    3. Patients who have had prior whole-brain radiation therapy (WBRT) and/or SRS and then whose lesions have progressed are eligible. Lesions treated with SRS may be eligible if there is unequivocal evidence of progression
    4. Progression after prior systemic therapy.

Exclusion Criteria:

  • Participants who received major surgery must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
  • Has a diagnosis of immunodeficiency or hypersensitivity to ipilimumab or any of its excipients (Cohorts C and D).
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
  • Has a known additional malignancy that is progressing or requires active treatment.
  • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  • Unable to undergo brain MRI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
Patients with brain metastases from non-small cell lung cancer receiving stereotactic radiosurgery to selected lesions
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.
Other Names:
  • Vessel Architectural Imaging
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.
B
Patients with brain metastases from malignant melanoma receiving stereotactic radiosurgery to selected lesions
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.
Other Names:
  • Vessel Architectural Imaging
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.
C
Patients with brain metastases from non-small cell lung cancer receiving stereotactic radiosurgery to selected lesions + nivolumab or pembrolizumab
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.
Other Names:
  • Vessel Architectural Imaging
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.
Other Names:
  • Immunotherapy
D
Patients with brain metastases from malignant melanoma receiving stereotactic radiosurgery to selected lesions + ipilimumab, nivolumab or pembrolizumab
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.
Other Names:
  • Vessel Architectural Imaging
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.
Other Names:
  • Immunotherapy
E
Patients with brain metastases from non-small cell lung cancer receiving stereotactic radiosurgery to selected lesions + epidermal growth factor receptor (EGFR) inhibitors
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.
Other Names:
  • Vessel Architectural Imaging
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Response
Time Frame: 18 months
Radionecrosis, pseudoprogression or tumor progression by Response Assessment in Neuro-Oncology Criteria (RANO) or histology, or radiographic/clinical progression free survival
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 years
Overall survival
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

Massachusetts General Hospital
Dana-Farber Cancer Institute
University Medical Center Groningen
Ostfold Hospital Trust
University of Texas Southwestern Medical Center
St. Olavs Hospital
Norwegian Cancer Society
South-Eastern Norway Regional Health Authority
Hospital of Southern Norway Trust

Investigators

  • Principal Investigator: Kyrre E Emblem, PhD, Oslo University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2013

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

March 2, 2018

First Submitted That Met QC Criteria

March 2, 2018

First Posted (Actual)

March 8, 2018

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/1033 LOOPS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Within one year following study end, anonymized data will be uploaded to the appropriate online repositories to promote open access. This anonymized data includes general clinical information deemed non-identifiable (age, weight, gender, diagnosis and any prior treatments), imaging data (MRI with exam intervals only, no dates), corresponding results of any tissue analyses as well as study treatments (with treatment doses and intervals, no dates).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Brain Metastases

Clinical Trials on Magnetic Resonance Imaging

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe