Improved Therapy Response Assessment in Metastatic Brain Tumors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Treatment Response
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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.
排除标准
- •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
研究组 & 干预措施
A
Patients with brain metastases from non-small cell lung cancer receiving stereotactic radiosurgery to selected lesions
干预措施: Magnetic Resonance Imaging (Diagnostic Test)
A
Patients with brain metastases from non-small cell lung cancer receiving stereotactic radiosurgery to selected lesions
干预措施: Stereotactic Radiosurgery (Radiation)
B
Patients with brain metastases from malignant melanoma receiving stereotactic radiosurgery to selected lesions
干预措施: Magnetic Resonance Imaging (Diagnostic Test)
B
Patients with brain metastases from malignant melanoma receiving stereotactic radiosurgery to selected lesions
干预措施: Stereotactic Radiosurgery (Radiation)
C
Patients with brain metastases from non-small cell lung cancer receiving stereotactic radiosurgery to selected lesions + nivolumab or pembrolizumab
干预措施: Magnetic Resonance Imaging (Diagnostic Test)
C
Patients with brain metastases from non-small cell lung cancer receiving stereotactic radiosurgery to selected lesions + nivolumab or pembrolizumab
干预措施: Stereotactic Radiosurgery (Radiation)
C
Patients with brain metastases from non-small cell lung cancer receiving stereotactic radiosurgery to selected lesions + nivolumab or pembrolizumab
干预措施: Ipilimumab, nivolumab or pembrolizumab (Drug)
D
Patients with brain metastases from malignant melanoma receiving stereotactic radiosurgery to selected lesions + ipilimumab, nivolumab or pembrolizumab
干预措施: Magnetic Resonance Imaging (Diagnostic Test)
D
Patients with brain metastases from malignant melanoma receiving stereotactic radiosurgery to selected lesions + ipilimumab, nivolumab or pembrolizumab
干预措施: Stereotactic Radiosurgery (Radiation)
D
Patients with brain metastases from malignant melanoma receiving stereotactic radiosurgery to selected lesions + ipilimumab, nivolumab or pembrolizumab
干预措施: Ipilimumab, nivolumab or pembrolizumab (Drug)
E
Patients with brain metastases from non-small cell lung cancer receiving stereotactic radiosurgery to selected lesions + epidermal growth factor receptor (EGFR) inhibitors
干预措施: Magnetic Resonance Imaging (Diagnostic Test)
E
Patients with brain metastases from non-small cell lung cancer receiving stereotactic radiosurgery to selected lesions + epidermal growth factor receptor (EGFR) inhibitors
干预措施: Stereotactic Radiosurgery (Radiation)
结局指标
主要结局
Treatment Response
时间窗: 18 months
Radionecrosis, pseudoprogression or tumor progression by Response Assessment in Neuro-Oncology Criteria (RANO) or histology, or radiographic/clinical progression free survival
次要结局
- Overall survival(5 years)
研究者
Kyrre Eeg Emblem
Principal Investigator
Oslo University Hospital