Brain MetastasesTREATMENTNCT03458455
Improved Therapy Response Assessment in Metastatic Brain Tumors
An observational study of Brain Metastases, run by Oslo University Hospital at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases
- What is being tested?
- Magnetic Resonance Imaging, Stereotactic Radiosurgery and Ipilimumab, nivolumab or pembrolizumab
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteNorway
- Study dates
- 1 Mar 2013to 31 Dec 2024
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 12Show fewer
- 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:
- Untreated measurable lesions in patients that have received surgery and/or SRS to one or more other lesions
- Residual or progressive lesions after surgery if asymptomatic
- 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
- Progression after prior systemic therapy.
Who cannot join
- 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.
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
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
- Being tested
- Magnetic Resonance Imaging, Stereotactic Radiosurgery, Ipilimumab, nivolumab or pembrolizumab
- Keywords
- TREATMENT, Vessel Architectural Imaging, Brain Metastases
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingDiagnostic test
Also called Vessel Architectural 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 RadiosurgeryRadiation
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 pembrolizumabDrug
Also called Immunotherapy
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 group | Role | What they receive |
|---|---|---|
| A | Patients with brain metastases from non-small cell lung cancer receiving stereotactic radiosurgery to selected lesions Receives: Diagnostic Test: Magnetic Resonance Imaging; Radiation: Stereotactic Radiosurgery | |
| B | Patients with brain metastases from malignant melanoma receiving stereotactic radiosurgery to selected lesions Receives: Diagnostic Test: Magnetic Resonance Imaging; Radiation: Stereotactic Radiosurgery | |
| C | Patients with brain metastases from non-small cell lung cancer receiving stereotactic radiosurgery to selected lesions + nivolumab or pembrolizumab Receives: Diagnostic Test: Magnetic Resonance Imaging; Radiation: Stereotactic Radiosurgery; Drug: Ipilimumab, nivolumab or pembrolizumab | |
| D | Patients with brain metastases from malignant melanoma receiving stereotactic radiosurgery to selected lesions + ipilimumab, nivolumab or pembrolizumab Receives: Diagnostic Test: Magnetic Resonance Imaging; Radiation: Stereotactic Radiosurgery; Drug: Ipilimumab, nivolumab or pembrolizumab | |
| E | Patients with brain metastases from non-small cell lung cancer receiving stereotactic radiosurgery to selected lesions + epidermal growth factor receptor (EGFR) inhibitors Receives: Diagnostic Test: Magnetic Resonance Imaging; Radiation: Stereotactic Radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Response
Radionecrosis, pseudoprogression or tumor progression by Response Assessment in Neuro-Oncology Criteria (RANO) or histology, or radiographic/clinical progression free survival
Measured: 18 months
Secondary outcomes (1)
Overall survival
Overall survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start1 Mar 2013
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital of Southern Norway Trust, Ostfold Hospital Trust, St. Olavs Hospital, Massachusetts General Hospital, Dana-Farber Cancer Institute, University Medical Center Groningen, University of Texas Southwestern Medical Center, South-Eastern Norway Regional Health Authority, Norwegian Cancer Society
- Responsible party
- Principal investigator, Kyrre Eeg Emblem, Oslo University Hospital
- Investigators
- Kyrre E Emblem, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03458455
- Sponsor's protocol ID
- 2013/1033 LOOPS
- Acronym
- TREATMENT
- Status last verified
- Oct 2023
- First submitted
- 2 Mar 2018
- Last updated
- 1 Nov 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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).
Publications
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.
PubMed 26222087Emblem 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.
PubMed 25113840Emblem 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.
PubMed 23955713Lin 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.
PubMed 26065612Lin 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.
PubMed 23993385Lin 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.
PubMed 23993384Digernes 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.
PubMed 28273722Angeli 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.
PubMed 30211003Nilsen 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.
PubMed 32642687Seano 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.
PubMed 30948807Digernes 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.
PubMed 30370356
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Therapy Response Assessment in Metastatic Brain Tumors
- ClinicalTrials.gov ID
- NCT03458455
- Acronym / sponsor ID
- TREATMENT / 2013/1033 LOOPS
- Conditions
- Brain Metastases
- Keywords
- TREATMENT, Vessel Architectural Imaging, Brain Metastases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Hospital of Southern Norway Trust, Ostfold Hospital Trust, St. Olavs Hospital, Massachusetts General Hospital, Dana-Farber Cancer Institute, University Medical Center Groningen, University of Texas Southwestern Medical Center, South-Eastern Norway Regional Health Authority, Norwegian Cancer Society
- Study start
- 1 Mar 2013 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| A | – | Diagnostic Test: Magnetic Resonance Imaging, Radiation: Stereotactic RadiosurgeryPatients with brain metastases from non-small cell lung cancer receiving stereotactic radiosurgery to selected lesions |
| B | – | Diagnostic Test: Magnetic Resonance Imaging, Radiation: Stereotactic RadiosurgeryPatients with brain metastases from malignant melanoma receiving stereotactic radiosurgery to selected lesions |
| C | – | Diagnostic Test: Magnetic Resonance Imaging, Radiation: Stereotactic Radiosurgery, Drug: Ipilimumab, nivolumab or pembrolizumabPatients with brain metastases from non-small cell lung cancer receiving stereotactic radiosurgery to selected lesions + nivolumab or pembrolizumab |
| D | – | Diagnostic Test: Magnetic Resonance Imaging, Radiation: Stereotactic Radiosurgery, Drug: Ipilimumab, nivolumab or pembrolizumabPatients with brain metastases from malignant melanoma receiving stereotactic radiosurgery to selected lesions + ipilimumab, nivolumab or pembrolizumab |
| E | – | Diagnostic Test: Magnetic Resonance Imaging, Radiation: Stereotactic RadiosurgeryPatients with brain metastases from non-small cell lung cancer receiving stereotactic radiosurgery to selected lesions + epidermal growth factor receptor (EGFR) inhibitors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance ImagingAlso: Vessel Architectural ImagingVessel 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. | Diagnostic test | A, B, C, D, E |
| Stereotactic RadiosurgeryA 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. | Radiation | A, B, C, D, E |
| Ipilimumab, nivolumab or pembrolizumabAlso: ImmunotherapyA 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. | Drug | C, D |
Primary outcome
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
1 secondary outcome
Overall survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Background: PubMed 26222087Gerstner 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.
- Background: PubMed 25113840Emblem 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.
- Background: PubMed 23955713Emblem 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.
- Background: PubMed 26065612Lin 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.
- Background: PubMed 23993385Lin 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.
- Background: PubMed 23993384Lin 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.
- Results publication: PubMed 28273722Digernes 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.
- Results publication: PubMed 30211003Angeli 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.
- Results publication: PubMed 32642687Nilsen 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.
- Results publication: PubMed 30948807Seano 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.
- Results publication: PubMed 30370356Digernes 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.
- Brain metastases with poor vascular function are susceptible to pseudoprogression after stereotactic radiation surgeryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyrre E Emblem, PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Metastases, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Response (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03458455, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.