An observational study in Brain Metastases, sponsored by Oslo University Hospital. Active, not recruiting at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-01.
Sponsored by Oslo University Hospital · Observational
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Among 21 studies in Brain Neoplasms with a site in Norway — 5 open to participants now, 10 under way, 3 of them phase 3. Brain Neoplasms · Norway.
Among the 21 studies in Brain Neoplasms with a site in Norway, this one is the only one that started in 2013, is one of 7 observational ones, and was the 15th registered.
2,441 studies on the registry are indexed under Brain Neoplasms; 541 are open to participants now.
Browse Brain Neoplasms studies →5 of the 21 studies in Brain Neoplasms with a site in Norway are open now. Recruiting first, the newest first:
Bristol-Myers Squibb · Sites in Norway, United States, Belgium and 10 more countries
Ages 18+
St. Olavs Hospital · Sites in Norway
Ages 18+
Norwegian University of Science and Technology · Sites in Norway
Ages 18+
Melanoma Institute Australia · Sites in Norway, Australia
Ages 18–120
Kyrre Eeg Emblem · Sites in Norway
Ages 18+
A study can be open while its sites in Norway have not opened yet or have stopped. Only those recruiting at a site in Norway →
Of the 424 Brain Neoplasms studies recruiting now, 285 (67%) set no upper age limit and 82 (19%) stop at 75 or younger; 80 take children under 18; 36 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
21 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 5 · Phase 3 7
First in 1999; this study’s year is marked. 1 started in 2013.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 200 is above the median of 99 across 433 observational studies indexed under Brain Neoplasms.
Median enrollment 221 across the 14 interventional studies, 142 across the 7 observational. Of the 10 that completed or were terminated, 2 (20%) have results posted.
This tab as a report to print or save as PDF → With an account.
4 of 21 have an industry lead sponsor. The 10 most frequent:
Oslo University Hospital is the lead sponsor of 834 studies on the registry; 149 are open to participants now.
Oslo University Hospital has 4 studies filed under Brain Neoplasms — fewer than ten, so there is no comparison to draw.
3 of the studies in Brain Neoplasms with a site in Norway that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02066220Phase 3Universitätsklinikum Hamburg-EppendorfInternational Society of Paediatric Oncology (SIOP) PNET 5 Medulloblastoma | 2026-12 |
| NCT03340129Melanoma Institute AustraliaAnti-PD 1 Brain Collaboration + Radiotherapy Extension (ABC-X Study) | 2026-12 |
| NCT05416567St. Olavs HospitalEmbolization for Meningioma | 2027-08 |
Add all 3 to your calendar (.ics) → With an account.
Among the 21 studies in Brain Neoplasms with a site in Norway, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Previously untreated asymptomatic - or - progressive brain metastases after systemic therapy or prior local therapy such as radiation or surgery as defined by:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with brain metastases from non-small cell lung cancer receiving stereotactic radiosurgery to selected lesions
Diagnostic Test: Magnetic Resonance Imaging · Radiation: Stereotactic Radiosurgery
Patients with brain metastases from malignant melanoma receiving stereotactic radiosurgery to selected lesions
Diagnostic Test: Magnetic Resonance Imaging · Radiation: Stereotactic Radiosurgery
Patients with brain metastases from non-small cell lung cancer receiving stereotactic radiosurgery to selected lesions + nivolumab or pembrolizumab
Diagnostic Test: Magnetic Resonance Imaging · Radiation: Stereotactic Radiosurgery · Drug: Ipilimumab, nivolumab or pembrolizumab
Patients with brain metastases from malignant melanoma receiving stereotactic radiosurgery to selected lesions + ipilimumab, nivolumab or pembrolizumab
Diagnostic Test: Magnetic Resonance Imaging · Radiation: Stereotactic Radiosurgery · Drug: Ipilimumab, nivolumab or pembrolizumab
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 · Radiation: Stereotactic Radiosurgery
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.
Also known as: Vessel Architectural Imaging
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.
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.
Also known as: Immunotherapy
This study also gives Pembrolizumab, Nivolumab, Ipilimumab. No intervention listed here names it: that was found by reading the record.
Treatment Response
Radionecrosis, pseudoprogression or tumor progression by Response Assessment in Neuro-Oncology Criteria (RANO) or histology, or radiographic/clinical progression free survival
Time frame: 18 months
Overall survival
Overall survival
Time frame: 5 years
Plan to share: 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).
Started Mar 2013 (actual). Primary completion is estimated for Jul 2024, 136 months after the start.
Of 181 non-industry observational studies under Brain Neoplasms, half reached primary completion within 82 months of starting (the median), counting those still running; a quarter within 42 and three quarters within 269. This study's planned 136 months is above that.
Counting every sponsor, half of 199 studies reached it within 82 months; a quarter within 41 and three quarters within 269.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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