NL-OMON53583尚未招募不适用
Multispectral and bimodal fluorescent guided surgery (FGS) of high-grade glioma for refining margin assessment: A phase 1 dose finding study using Cetuximab-IRDye800CW- combined with 5-ALA. (*MIRROR study*) - MIRROR-study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 21
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Willing to adhere to the prohibitions and restrictions specified in this
- •- Capable of giving signed informed consent (voluntarily), indicating that the
- •patient understands the purpose and procedures required for the study and is
- •willing to comply with the requirements and restrictions listed in the informed
- •consent form and in this protocol.
- •- Patients aged >= 18 years inclusive at moment signing informed consent form.
- •- Established High-grade glioma (astrocytoma grade 4 according to the WHO
- •classification) and scheduled for surgical intervention.
- •- Life expectancy of > 12 weeks.
- •- Karnofsky performance status of at least 70%.
- •- No clinically significant laboratory abnormalities as determined by the
- •investigator
- •o Note: one retest of lab tests is allowed within the screening window
- •- Female patients should fulfil one of the following criteria:
- •o At least 1 year post-menopausal (amenorrhea >12 months) at screening
- •o Surgically sterile (bilateral oophorectomy, hysterectomy, or tubal ligation)
- •o Women >18 years of age who are fertile, need to agree to use an adequate form
- •of contraceptives during and till 3 months after the study. Before study
- •enrollment, a pregnancy test in blood or urine will be performed to rule out a
- •pregnancy. In the case of an unlikely pregnancy during the study, they accept
- •the possible maternal/ fetal risk of participation in the study.
排除标准
- •- Behavioral or cognitive impairment or psychiatric disease that in the opinion
- •of the investigator affects the ability of the patient to understand and
- •cooperate with the study protocol
- •- Deprived of freedom by an administrative or court order or in an emergency
- •- Insufficient venous access for the study procedures.
- •- Close affiliation with the investigator; e.g. a close relative of the
- •investigator,
- •dependent person (e.g. employee or student), employee of the department of
- •Neurosurgery of the UMCG, or affiliates
- •- Any finding in the medical examinations or medical history giving, that in
- •the opinion of the investigator, leads to a reasonable suspicion of a disease
- •or condition that makes treatment with the investigational drug unadvisable, or
- •that might affect interpretation of the results of the study or render the
- •patient at high risk for treatment complications
- •- Participation in an interventional clinical study within 30 days prior to
- •tracer administration that involved treatment with any drug (excluding vitamins
- •and minerals) or medical device
- •Medical conditions
- •- Concomitant malignancies, including metastasized colon-, rectal-, breast
- •carcinoma, non-small cellular lung carcinoma (NSCLC); primary epithelial
- •ovarian-, fallopian tube-, primary peritoneal- or cervical carcinoma.
- •- Any abnormalities in the vital signs of the patient, as judged by the
- •investigator, as a result of which the patient cannot participate
- •- eGFR (based on plasma-creatinine) outside of normal range at screening or
- •known renal impairment (<=40 mL/min).
- •- Current evidence or history of bacterial, viral or fungal infections within 7
- •days before Cetuximab-IRDye800CW administration, as judged by the Investigator.
- •o T > = 38.0°C or lab confirmed viral/bacterial/fungal infection (PCR)) or
- •symptoms suggestive of an infection)
- •- Any laboratory test which is abnormal, and which is deemed by the
- •Investigator(s) to be clinically significant
- •- A history of anaphylaxis, history of allergic reaction(s), known allergy to
- •one of the drugs or excipients administered as part of this study. Mild
- •allergies without angio-edema or treatment need can be acceptable if deemed not
- •to be of clinical significance (including but not limited to allergy to animals
- •or mild seasonal hay fever)
研究者
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