EUCTR2012-003666-41-BE进行中（未招募）1 期
The LuMEn study177Lu-octreotate treatment outcome prediction using Multimodality imaging in refractory neuroEndocrine tumours - LuMEn
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 52
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
- •Inclusion Criteria: Patient-based
- •1.Age above or equal to 18 years.
- •2.Histology-proven advanced GEP-NETs.
- •3.Disease progression defined as follows (at least one of the following):
- •-Radiological disease progression (according to RECIST 1.1) on an MRI or CT over the last 12 months
- •-Disease progression on a somatostatin receptor-imaging, PET/CT or SPECT/CT over the last 12 months [apparition of new lesion(s) or increase in the transaxial plane diameter of more than 30% on the same imaging modality]
- •-Both of the following criteria (a+b):
- •a. clinical progression:
- •- sustained (for more than 2 weeks) increase of NET-specific hormonal hypersecretion related symptom frequency by 50% or,
- •- sustained (for more than 2 weeks) increase of severity by 1 grade (according to NCI-CTCAE version 4.03).
- •b. biochemical progression: by increase of NET-specific tumor markers (plasma Chromogranin A, plasma NSE, urine 5-HIAA or other) in two successive measurements.
- •4.Disease refractory to SSA’s and/or standard systemic therapy available in Belgium at the time of inclusion criteria.
- •5.Long-acting SSAs should be discontinued at least 4 weeks before study treatment start date and, if needed, switched to short-acting analogues which should be stopped 48h before the treatment date.
- •6.Adequate renal function with GFR = 50 mL/min/1.73m2 (evaluated by 51Cr-EDTA test).
- •7.Adequate bone marrow function with hemoglobin = 9 g/dL; neutrophil = 1.5·103/µL; platelet count = 100·103/µL.
- •8.Adequate liver function with total bilirubin = 2 x ULN and transaminases = 5 x ULN, serum albumin > 3 g/dL with normal prothrombin time (> 70%).
- •9.ECOG Performance Status = 1.
- •10.Women of childbearing potential and men with partners of childbearing potential must agree to use a highly-effective form of contraception for the duration of study participation and up to six months after the end of the treatment. A pregnancy test (serum) must be performed within 4 weeks prior to inclusion for every female patient of childbearing potential and it must be negative.
- •11.Patient’s written informed consent obtained prior to any study procedure.
- •12.All necessary baseline procedures should be performed within 4 weeks prior to first 177Lu-octreotate injection (D0).
- •Inclusion Criteria: Lesion-based
- •13.The patient must have at least one target lesion fulfilling all of the below criteria:
- •On the 68Ga-octreotate PET/CT: tumor uptake higher than the physiological liver uptake (grade III or IV of the Rotterdam visual score30) in a lesion with longest transaxial plane diameter = 20mm (measured on the CT, part of the PET/CT);
- •At least one of these lesions morphologically measurable according to RECIST 1.1 and progressive on the MRI (or CT if MRI is not applicable);
- •Target lesion shall not have been previously irradiated.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 26
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 26
排除标准
- •1.Resectable tumor with curative intent.
- •2.Any major surgery within the last 6 weeks prior to inclusion in the study
- •3.Radiotherapy, chemotherapy, embolization, mammalian target of rapamycin (mTOR)-inhibitors, receptor tyrosine-kinase inhibitors, interferon, or other investigational therapy within the last 12 weeks prior to inclusion in the study.
- •4.Diffuse bone marrow infiltration on the baseline 68Ga-octreotate PET/CT confirmed by MRI.
- •5.Prior external beam radiotherapy on kidneys or on more than 25% of bone marrow.
- •6.Patients with known uncontrolled brain metastases.
- •7.Patients with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the investigator’s opinion, may interfere with completion of the study.
- •8.Pregnant or lactating patients.
- •9.Women of childbearing potential and men with partners of child-bearing potential refusing an adequate contraception.
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