NL-OMON52180尚未招募4 期
Prospective evaluation of potential effects of repeated gadoliniumbased contrast agent (GBCA) administrations of the same GBCA on motor and cognitive functions in neurologically normal adults in comparison to a non-GBCA exposed control group*ODYSSEY - Longterm study of GBCAs on motor, cognitive function after repeated CE-MRI
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- IQvia
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Participant must be an adult having reached legal majority age and less than
- •2. Participant must be neurologically normal, defined as free of unstable
- •neurologic and
- •psychiatric disease as confirmed by a normal neurologic examination at
- •3. Participant agrees to be tested as per protocol for 5 consecutive years
- •4. Participant (GBCA-exposed or controls) agrees to undergo UE-MRI of the brain
- •enrollment and at the end of the observation period (5 years).
- •5. Patient affiliated to national health insurance according to local regulatory
- •requirements, where applicable.
- •6. Participants should have at least 1 of the following indications:
- •Medium to high risk for breast cancer or with dense breasts undergoing breast
- •cancer screening with MRI
- •Elevated PSA under active diagnostic surveillance of prostate cancer
- •Chronic liver disease (eg. liver cirrhosis limited to Child Class A,
- •post-hepatitis
- •chronic hepatopathy, or primary sclerosing cholangitis) for surveillance of
- •hepatocellular carcinoma development
- •Low-grade colorectal cancer or neuroendocrine tumor undergoing surveillance
- •liver metastases
- •Branch-duct intraductal papillary mucinous neoplasm (IPMN) of the pancreas
- •(maximum size <= 2 cm) undergoing imaging surveillance.
排除标准
- •1. As evidenced by history or determined in the neurologic exam at screening,
- •neurological and/or psychiatric disease (or treatments) that could influence
- •the results
- •of the study*s motor and cognitive tests. Examples include but are not limited
- •Cerebrovascular disease.
- •Multiple sclerosis.
- •Neurodegenerative disease.
- •Malignant disease other than listed in indications.• Carcinoid tumors.
- •Epilepsy.
- •Prior neurosurgery.
- •Psychotic disorders or any prior psychotic episode not otherwise specified
- •(NOS)*any documented prior history of chronic schizophrenia.
- •Remittent or current medically confirmed major depressive disorder or bipolar
- •disorder. History of long-term major depression or bipolar affective disorder
- •an active episode in the past 2 to 5 years.
- •Neurodevelopmental disorders (eg, trisomy 21).
- •Uncontrolled severe migraine.
- •Uncontrolled or controlled anxiety or depression within 6 months before
- •enrollment.
- •Screening scores of <=24 on the MMSE and/or >=11 on the HADS.
- •2. Prior, planned, or ongoing chemotherapy or brain irradiation.
- •3. Use of concomitant medication(s) affecting neuro-cognitive or motor function
- •authorized exception is a single intake before the study MRI because of anxiety
- •administered after the motor and cognitive test evaluation):
- •Regular use of benzodiazepines or non-benzodiazepine hypnotics. Long-acting
- •benzodiazepines (eg, diazepam) should not be administered within 24 hours prior
- •to cognitive testing.
- •Short/medium-acting benzodiazepines (eg, alprazolam, lorazepam, oxazepam,
- •temazepam), except if used chronically for sleep and on a stable dose for 8
- •prior to Screening Visit 1 or 12 hours prior to cognitive testing.
- •Regular use of anticholinergic drugs (anticholinergics for bladder control
- •limited cognitive effects are permitted).
- •Long-term use of corticosteroids or methotrexate, cladribine.
- •Regular use of antidepressants (eg, anticholinergics, tricyclics, monoamine
- •inhibitors [MAOIs], norepinephrine-dopamine reuptake inhibitors [NDRIs],
- •selective serotonin reuptake inhibitors [SSRIs], serotonin and norepinephrine
- •reuptake inhibitors [SNRIs], or lithium, anti-epileptics, and/or antipsychotic
- •Use of antidepressants is allowed if at stable doses for 8 weeks prior to
- •Visit. Antipsychotics used on a regular basis, except for low doses of atypical
- •antipsychotics (e.g., risperidone, aripiprazole, or quetiapine),
- •anticonvulsants with
- •limited cognitive effects, such as lamotrigine, pregabalin, levetiracetam for
- •treatment of pain, and other non-epilepsy indications, are allowed as-needed
- •or if used at a stable dose for 8 weeks prior to Screening Visit
- •CNS stimulants (eg, for ADHD).
- •4. Substance or alcohol abuse as determined by the investigator.
- •5. Alcoholic cirrhosis.
- •6. Any history or presence of other relevant chronic disease that prevents
- •participation in
- •the study or that may confound neurofunction testing.
- 另有 4 项未显示
研究者
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