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.
Condition or disease | Intervention/treatment |
---|---|
Brain Metastases | Diagnostic Test: Magnetic Resonance Imaging Radiation: Stereotactic Radiosurgery Drug: Ipilimumab, nivolumab or pembrolizumab |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 200 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 18 Months |
Official Title: | Improved Therapy Response Assessment in Metastatic Brain Tumors |
Actual Study Start Date : | March 1, 2013 |
Estimated Primary Completion Date : | June 30, 2021 |
Estimated Study Completion Date : | December 31, 2022 |
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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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.
|
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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.
Inclusion Criteria:
Previously untreated asymptomatic brain metastases - or - progressive brain metastases after systemic therapy or prior local therapy such as radiation or surgery as defined by:
Exclusion Criteria:
Contact: Kyrre E Emblem, PhD | 97080018 ext 0047 | Kyrre.Eeg.Emblem@rr-research.no | |
Contact: Endre Groevik, PhD | 97525211 ext 0047 | endre.grovik@mn.uio.no |
Norway | |
Oslo University Hospital | Recruiting |
Oslo, Norway, 0424 | |
Contact: Anne Catrine T Martinsen, PhD 99216566 ext 0047 uxneti@ous-hf.no | |
Contact: Atle Bjornerud, PhD 97539499 ext 0047 atle.bjornerud@fys.uio.no |
Principal Investigator: | Kyrre E Emblem, PhD | Oslo University Hospital |
Tracking Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
First Submitted Date | March 2, 2018 | ||||||||
First Posted Date | March 8, 2018 | ||||||||
Last Update Posted Date | February 26, 2021 | ||||||||
Actual Study Start Date | March 1, 2013 | ||||||||
Estimated Primary Completion Date | June 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures |
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
|
||||||||
Original Primary Outcome Measures | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures |
Overall survival [ Time Frame: 5 years ] Overall survival
|
||||||||
Original Secondary Outcome Measures | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title | Improved Therapy Response Assessment in Metastatic Brain Tumors | ||||||||
Official Title | Improved Therapy Response Assessment in Metastatic Brain Tumors | ||||||||
Brief 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 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. |
||||||||
Detailed Description | Not Provided | ||||||||
Study Type | Observational [Patient Registry] | ||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||||
Target Follow-Up Duration | 18 Months | ||||||||
Biospecimen | Not Provided | ||||||||
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. |
||||||||
Condition | Brain Metastases | ||||||||
Intervention |
|
||||||||
Study Groups/Cohorts |
|
||||||||
Publications * |
|
||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
Recruitment Information | |||||||||
Recruitment Status | Recruiting | ||||||||
Estimated Enrollment |
200 | ||||||||
Original Estimated Enrollment | Same as current | ||||||||
Estimated Study Completion Date | December 31, 2022 | ||||||||
Estimated Primary Completion Date | June 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||
Sex/Gender |
|
||||||||
Ages | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts |
|
||||||||
Listed Location Countries | Norway | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT03458455 | ||||||||
Other Study ID Numbers | 2013/1033 LOOPS | ||||||||
Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
|
||||||||
IPD Sharing Statement |
|
||||||||
Responsible Party | Kyrre Eeg Emblem, Oslo University Hospital | ||||||||
Study Sponsor | Oslo University Hospital | ||||||||
Collaborators |
|
||||||||
Investigators |
|
||||||||
PRS Account | Oslo University Hospital | ||||||||
Verification Date | February 2021 |