NL-OMON41217尚未招募不适用
IDENTIFICATION OF NEUROENDOCRINE NEOPLASMS AND ASSESSMENT OF RESPONSE TO PEPTIDE RECEPTOR RADIONUCLIDE THERAPY (PRRT) WITH 177Lu-OCTREOTATE UTILIZING A MULTIGENE PCR-BASED BLOOD ANALYSIS - The LuGenIum PRRT tumor response study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 45
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 99（—）
入选标准
- •Patient is affected by an inoperable Neuroendocrine Tumor and eligible for treatment with PRRT based on the following criteria:;- The capacity to understand and willingness to sign an informed consent form, obtained prior to enrolment into the study;And meets the standard conditions for treatment with PRRT:
- •- Presence of histology proven GEP tumor(s), including bronchial carcinoids
- •- Presence of somatostatin-receptors on the known tumor lesions demonstrated by OctreoScan® within 6 months of the first dose of radiolabelled octreotate/octreotide. The uptake on the OctreoScan® should be at least as high as normal liver uptake on planar imaging
- •- Life expectancy greater than 12 weeks
- •- Serum creatinine <=150 µmol/liter or 1.7 mg/dL, and a measured creatinine clearance (or measured GFR using plasma clearance methods, not gamma-camera based) of >=50 mL/min
- •- Hemoglobin (HgB) concentration >=5.5 mmol/L (>=8.9 g/dL); WBC >=2.0*109/L (2000/mm3); platelets >=75*109/L (75*103/mm3)
- •- Total bilirubin <=3 x ULN
- •- Serum albumin >30 g/L, or serum albumin <=30 g/L but normal prothrombin time
- •- Karnofsky Performance Status >=60
- •- Presence of at least 1 measurable site of disease
排除标准
- •Patient is not eligible for PRRT or an alternative treatment is available:;A potential subject who meets any of the standard contraindications for treatment with PRRT will not be able to participate in this study:
- •- Possible surgery with curative intent
- •- Surgery, radiotherapy, chemotherapy or other investigational therapy within 3 months of
- •the start of therapy
- •- Patients with known brain metastases unless these metastases have been treated and
- •stabilized for at least six months prior to study start. Patients with a history of brain
- •metastases must have a head CT with contrast to document stable disease prior to study
- •- Uncontrolled congestive heart failure
- •- Any subject who is taking concomitant medications which decrease renal function
- •- Any subject receiving therapy with somatostatin analogues in whom these analogues cannot be interrupted for 12 hours before and 12 hours after the administration of the radiolabelled somatostatin analogues, or any subject receiving therapy with long-acting somatostatin analogues in whom these analogues cannot be interrupted for at least 6 weeks before the administration of the radiolabelled somatostatin analogues, unless the uptake on the OctreoScan® during continued somatostatin analogue medication is at least as high as normal liver uptake on planar imaging
- •- In patients with unusual haematological parameters, including an increased MCV
- •(>105fL), and especially in those who had previous chemotherapy, the advice of a hematologist should be seeked, for adequate further work up
- •- Subjects with another significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the study.
- •- Pregnancy
- •- Prior radiation therapy to more than 25% of the bone marrow
研究者
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