NL-OMON53936尚未招募不适用
An open label pilot study of [18F]AlF-RESCA-IL2 (Interleukin-2 PET tracer) for positron emission tomography imaging in patients treated with immune checkpoint inhibitors - IL-2 PET imaging in advanced solid tumours
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational invasive
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Age >= 18 years at the time of signing informed consent.
- •2. Patients with histologically confirmed diagnosis of locally advanced or
- •metastatic solid cancer, eligible for ICI therapy as part of routine care.
- •3. At least 1 lesion that is accessible per investigator*s assessment and
- •eligible for biopsy according to standard clinical care procedures.
- •4. Measurable disease, as defined by standard RECIST v1.1. Previously
- •irradiated lesions should not be counted as target lesions except for lesions
- •that have progressed after radiotherapy.
- •5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •6. Life expectancy >= 12 weeks.
- •7. Signed informed consent.
- •8. Willingness and ability to comply with all protocol required procedures.
- •9. For female patients of childbearing potential and male patients with
- •partners of childbearing potential, agreement (by patient and/or partner) to
- •use a highly effective form(s) of contraception (i.e., one that results in a
- •low failure rate (< 1% per year) when used consistently and correctly)).
排除标准
- •1. Treatment with any other investigational agent or participation in another
- •clinical trial with therapeutic intent within 28 days prior to
- •[18F]AlF-RESCA-IL2 injection.
- •2. Evidence of an active infection that requires systemic antibiotics within 2
- •weeks prior to [18F]AlF-RESCA-IL2 injection.
- •3. Active HIV, Hepatitis-B or Hepatitis-C infection.
- •4. Any other diseases, metabolic dysfunction, physical examination finding, or
- •clinical laboratory finding giving reasonable suspicion of a disease or
- •condition that contraindicates the use of [18F]AlF-RESCA-IL2, or that may
- •affect the interpretation of the results or render the patient at high risk
- •from complications.
- •5. Altered mental status, or any psychiatric condition that would prohibit the
- •understanding or rendering of informed consent.
- •6. Sponsor employee/member of the clinical site study team and/or his or her
- •immediate family
- •7. Pregnant or lactating females.
- •8. Concurrent use of systemic corticosteroids > 10 mg daily prednisone
- •equivalent.
研究者
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