EUCTR2012-002029-31-GB进行中（未招募）1 期
A Cancer Research UK Phase I/II study to compare [124I]mIBG PET/CT to [123I]mIBG imaging in patients with metastatic neuroblastoma - A Phase I/II study of [124I]mIBG PET/CT in neuroblastoma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 33
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Histologically proven neuroblastoma with stage 4 disease as defined by the International Neuroblastoma Staging System (INSS).
- •2. Aged = 1 year at the time that written informed consent is given.
- •3. Planned to undergo conventional [123I]mIBG planar scintigraphy for routine clinical care of neuroblastoma.
- •4. Life expectancy of at least 12 weeks.
- •5. World Health Organisation (WHO) performance status of 0, 1 or 2 for patients aged >12 years old or Lansky play scale score of =50% for patients aged = 12 years old.
- •6. Written (signed and dated) informed consent from patient = 16 years old and/or parent or legal guardian for patients <16 years old and the patient be capable of co-operating with scanning requirements. (N.B. Written or verbal assent as appropriate should be sought from all patients who are under 16 years of age.)
- •Additional inclusion criteria for biokinetic sub-study
- •1. No requirement for general anaesthesia to undergo PET/CT scanning.
- •2. Written (signed and dated) informed consent for the sub-study from patients aged =16 years or from the patient’s parent or guardian for patients aged <16 years. Capable of co-operating with the additional study PET/CT scans. (N.B. Written or verbal assent as appropriate should be sought from all patients who are under 16 years old.)
- •Additional inclusion criteria for PET/MRI sub-study
- •1. No requirement for general anaesthesia to undergo hybrid PET/MRI scanning.
- •2. No previous experience of claustrophobia.
- •3. Written (signed and dated) informed consent for the sub-study from patients aged 16 years or from the patient’s parent or guardian for patients aged <16 years. Capable of co-operating with the additional study PET/MRI scans. (N.B. Written or verbal assent as appropriate should be sought from all patients who are under 16 years of age.)
- •Clinical Criteria for [124I]mIBG imaging:
- •The patient must fulfil the following clinical criteria prior to administration of [124I]mIBG Solution for Injection due to the limited clinical experience with this novel radiotracer. These criteria will be confirmed by the Clinical Study Manager or Clinical Research Associate at the CDD prior to the authorisation for use of [124I]mIBG Solution for Injection for each patient:
- •1. One or more metastatic disease foci observed on conventional [123I]mIBG planar scintigraphy. Disease foci will initially be identified by a Nuclear Medicine physician at the investigational site.
- •2. = 3kg at the time of the [124I]mIBG imaging to agree with the paediatric EANM guidelines.
- •3. Haematological and biochemical indices within the ranges shown below.
- •Values required for patients =16 years old
- •Laboratory Test Value required
- •Haemoglobin (Hb) = 7.0 g/dl (N.B. transfusions will be allowed)
- •Absolute neutrophil count (ANC) = 0.20 x 10^9/L (N.B. G-CSF support will be allowed)
- •Platelet count = 10 x 10^9/L (N.B. transfusions will be allowed)
- •Serum bilirubin = 2.5 x upper limit of normal (ULN)
- •ALT, AST, and/ or ALP = 5 x ULN
- •Calculated creatinine clearance using revised Schwartz formula = 60 mL/min/1.73m^2
- •Values required for patients >16 years old
- •Laboratory Test Value required
- •Haemoglobin (Hb) = 8.0 g/dl (N.B. transfusions will be allowed)
- •Absolute neutrophil count (ANC) = 0.50 x 10^9/L (N.B. G-CSF support will be allowed)
- •Platelet count = 50 x 10^9/L (N.B. transfusions will be allowed)
- •Serum bilirubin
排除标准
- •1. Treatment with any medications contra-indicated with mIBG scanning as listed in protocol. For example, decongestants containing pseudoephedrine, phenylpropalomine and phenylephrine, sympathomimetics, cocaine, antihypertensives, tricyclic antidepressants. These drugs should be stopped before administration as indicated in this list (usually for four biological half-lives to allow almost complete wash-out but refer to list). The Investigator should seek prospective approval of any planned variation from this list from the responsible Nuclear Medicine Consultant, CI and sponsor Medical Advisor.
- •2. Stage 4S neuroblastoma as defined by the INSS.
- •3. Any anti-cancer treatment planned between the routine [123I]mIBG imaging and the [124I]mIBG PET/CT scan on Day 2. Anti-cancer treatments can be started only after the Off-Study assessment on Day 3 to Day 7, see schedule of assessments in protocol. N.B. Patients should not be enrolled in the study if their participation will delay their subsequent treatment for neuroblastoma.
- •4. Female patients who are pregnant or lactating.
- •5. At high medical risk because of non-malignant systemic disease including active uncontrolled infection.
- •6. Known to be serologically positive for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV).
- •7. Patients with known hypersensitivity to mIBG.
- •8. Any other condition which in the Investigator’s opinion would not make the patient a good candidate for the clinical study.
研究者
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