Improved Therapy Response Assessment in Metastatic Brain Tumors
NCT ID: NCT03458455
Last Updated: 2023-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
200 participants
OBSERVATIONAL
2013-03-01
2024-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Brain Metastases in Norway - A Prospective Cohort Study
NCT03346655
Treatment Response Assessment Maps to Delineate Necrosis From Tumor After Stereotactic Radiation in Brain Metastases
NCT04033497
Response Prediction for Anti-angiogenic Treatment in Recurrent Glioblastoma
NCT04143425
Imaging Biomarkers of Tissue Microstructure and Vasculature as Predictors of Glioblastoma Multiforme
NCT01604590
MRI Study of Changes in Blood-Brain/Tumor-Barrier Permeability in Patients With Brain Metastases During and After Radiotherapy
NCT02031237
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A
Patients with brain metastases from non-small cell lung cancer receiving stereotactic radiosurgery to selected lesions
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.
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
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.
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
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.
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.
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.
D
Patients with brain metastases from malignant melanoma receiving stereotactic radiosurgery to selected lesions + ipilimumab, nivolumab or pembrolizumab
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.
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.
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.
E
Patients with brain metastases from non-small cell lung cancer receiving stereotactic radiosurgery to selected lesions + epidermal growth factor receptor (EGFR) inhibitors
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital of Southern Norway Trust
OTHER
Ostfold Hospital Trust
OTHER
St. Olavs Hospital
OTHER
Massachusetts General Hospital
OTHER
Dana-Farber Cancer Institute
OTHER
University Medical Center Groningen
OTHER
University of Texas Southwestern Medical Center
OTHER
South-Eastern Norway Regional Health Authority
OTHER
Norwegian Cancer Society
OTHER
Oslo University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Kyrre Eeg Emblem
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kyrre E Emblem, PhD
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Oslo University Hospital
Oslo, , Norway
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Gerstner ER, Emblem KE, Sorensen GA. Vascular Magnetic Resonance Imaging in Brain Tumors During Antiangiogenic Therapy--Are We There Yet? Cancer J. 2015 Jul-Aug;21(4):337-42. doi: 10.1097/PPO.0000000000000128.
Emblem KE, Farrar CT, Gerstner ER, Batchelor TT, Borra RJ, Rosen BR, Sorensen AG, Jain RK. Vessel caliber--a potential MRI biomarker of tumour response in clinical trials. Nat Rev Clin Oncol. 2014 Oct;11(10):566-84. doi: 10.1038/nrclinonc.2014.126. Epub 2014 Aug 12.
Emblem KE, Mouridsen K, Bjornerud A, Farrar CT, Jennings D, Borra RJ, Wen PY, Ivy P, Batchelor TT, Rosen BR, Jain RK, Sorensen AG. Vessel architectural imaging identifies cancer patient responders to anti-angiogenic therapy. Nat Med. 2013 Sep;19(9):1178-83. doi: 10.1038/nm.3289. Epub 2013 Aug 18.
Lin NU, Lee EQ, Aoyama H, Barani IJ, Barboriak DP, Baumert BG, Bendszus M, Brown PD, Camidge DR, Chang SM, Dancey J, de Vries EG, Gaspar LE, Harris GJ, Hodi FS, Kalkanis SN, Linskey ME, Macdonald DR, Margolin K, Mehta MP, Schiff D, Soffietti R, Suh JH, van den Bent MJ, Vogelbaum MA, Wen PY; Response Assessment in Neuro-Oncology (RANO) group. Response assessment criteria for brain metastases: proposal from the RANO group. Lancet Oncol. 2015 Jun;16(6):e270-8. doi: 10.1016/S1470-2045(15)70057-4. Epub 2015 May 27.
Lin NU, Wefel JS, Lee EQ, Schiff D, van den Bent MJ, Soffietti R, Suh JH, Vogelbaum MA, Mehta MP, Dancey J, Linskey ME, Camidge DR, Aoyama H, Brown PD, Chang SM, Kalkanis SN, Barani IJ, Baumert BG, Gaspar LE, Hodi FS, Macdonald DR, Wen PY; Response Assessment in Neuro-Oncology (RANO) group. Challenges relating to solid tumour brain metastases in clinical trials, part 2: neurocognitive, neurological, and quality-of-life outcomes. A report from the RANO group. Lancet Oncol. 2013 Sep;14(10):e407-16. doi: 10.1016/S1470-2045(13)70308-5.
Lin NU, Lee EQ, Aoyama H, Barani IJ, Baumert BG, Brown PD, Camidge DR, Chang SM, Dancey J, Gaspar LE, Harris GJ, Hodi FS, Kalkanis SN, Lamborn KR, Linskey ME, Macdonald DR, Margolin K, Mehta MP, Schiff D, Soffietti R, Suh JH, van den Bent MJ, Vogelbaum MA, Wefel JS, Wen PY; Response Assessment in Neuro-Oncology (RANO) group. Challenges relating to solid tumour brain metastases in clinical trials, part 1: patient population, response, and progression. A report from the RANO group. Lancet Oncol. 2013 Sep;14(10):e396-406. doi: 10.1016/S1470-2045(13)70311-5.
Digernes I, Bjornerud A, Vatnehol SAS, Lovland G, Courivaud F, Vik-Mo E, Meling TR, Emblem KE. A theoretical framework for determining cerebral vascular function and heterogeneity from dynamic susceptibility contrast MRI. J Cereb Blood Flow Metab. 2017 Jun;37(6):2237-2248. doi: 10.1177/0271678X17694187. Epub 2017 Jan 1.
Angeli S, Emblem KE, Due-Tonnessen P, Stylianopoulos T. Towards patient-specific modeling of brain tumor growth and formation of secondary nodes guided by DTI-MRI. Neuroimage Clin. 2018 Aug 31;20:664-673. doi: 10.1016/j.nicl.2018.08.032. eCollection 2018.
Nilsen LB, Digernes I, Grovik E, Saxhaug C, Latysheva A, Geier O, Breivik B, Saetre DO, Jacobsen KD, Helland A, Emblem KE. Responses in the diffusivity and vascular function of the irradiated normal brain are seen up until 18 months following SRS of brain metastases. Neurooncol Adv. 2020 Feb 28;2(1):vdaa028. doi: 10.1093/noajnl/vdaa028. eCollection 2020 Jan-Dec.
Seano G, Nia HT, Emblem KE, Datta M, Ren J, Krishnan S, Kloepper J, Pinho MC, Ho WW, Ghosh M, Askoxylakis V, Ferraro GB, Riedemann L, Gerstner ER, Batchelor TT, Wen PY, Lin NU, Grodzinsky AJ, Fukumura D, Huang P, Baish JW, Padera TP, Munn LL, Jain RK. Solid stress in brain tumours causes neuronal loss and neurological dysfunction and can be reversed by lithium. Nat Biomed Eng. 2019 Mar;3(3):230-245. doi: 10.1038/s41551-018-0334-7. Epub 2019 Jan 7.
Digernes I, Grovik E, Nilsen LB, Saxhaug C, Geier O, Reitan E, Saetre DO, Breivik B, Reese T, Jacobsen KD, Helland A, Emblem KE. Brain metastases with poor vascular function are susceptible to pseudoprogression after stereotactic radiation surgery. Adv Radiat Oncol. 2018 May 17;3(4):559-567. doi: 10.1016/j.adro.2018.05.005. eCollection 2018 Oct-Dec.
Related Links
Access external resources that provide additional context or updates about the study.
Brain metastases with poor vascular function are susceptible to pseudoprogression after stereotactic radiation surgery
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2013/1033 LOOPS
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.