EUCTR2016-002164-13-BE进行中（未招募）1 期
Quantification of 68GaNOTA-Anti-HER2 VHH1 Uptake in metastasis of Breast carcinoma and cancer patients and Assessment of Repeatability – Pilot study - VUBAR
Z Brussel0 个研究点目标入组 55 人开始时间: 2016年10月11日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 55
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
- •Patients will only be included in the study if they meet all of the following criteria:
- •- Patient who has given informed consent
- •- Patient with age 18 years or older
- •- Patient with locally or distantly advanced breast carcinoma, with at least 1 lesion of at least 12 mm maximal diameter. For lymph node metastases, the largest diameter should be at least 15 mm and the short axis at least 12 mm.
- •Patients will only be included in the study if they meet all of the following criteria:
- •- Patient who has given informed consent
- •- Patient with age 18 years or older
- •- Patient with locally advanced, unresectable, or metastatic cancer disease , with at least 1 lesion of at least 10 mm maximal diameter (For lymph node metastases, short axis at least 10 mm.) of any of the following types:
- •breast carcinoma with low, intermediate or high HER2-expression, based on IHC 1+, or IHC 2+ or IHC 3+, as determined by local assessment on any of the available cancer tissues
- •salivary gland cancer
- •adenocarcinoma of the gastric body or gastro-esophageal junction
- •endometrial cancer
- •cancer of cervix uteri
- •Non-small cell lung cancer
- •biliary tract cancer including intra- or extrahepatic cholangiocarcinoma and tumors arising in the ampulla of Vater or gallbladder.
- •pancreatic cancer
- •colorectal cancer
- •urothelial carcinoma, including transitional cell or predominantly transitional cell carcinoma of the renal pelvis, ureter, urinary bladder or urethra
- •prostate cancer
- •Other solid tumors with intermediate or high HER2-expression, based on IHC 2+ or IHC 3+, as determined by local assessment on any of the available cancer tissues
- •-Patient who has progressed on or relapsed after a prior treatment regimen, according to the treating physician (based on all available data such as medical imaging, lab results, clinical examination, …), and who is considered for a next line of treatment
- •-Patients who already participated in the trial and who are diagnosed with progressive or recurrent disease can be re-included if all inclusion criteria and none of the exclusion criteria apply.
- •Patients will only be included in the study if they meet all of the following criteria:
- •- Patient who has given informed consent
- •- Patient with age 18 years or older
- •- Patient with local or locally advanced HER2-positive (either IHC 3+ and/or ISH positive) breast carcinoma, who is planned for neo-adjuvant treatment prior to surgery, and who is suspected for axillary lymph node invasion, based on clinical assessment, ultrasound, CT or MRI, or who has a confirmed lymph node invasion
- •- Patients who either had 18F-FDG- PET/CT in the last 4 weeks before inclusion, or for whom 18F-FDG- PET/CT is planned before start of neoadjuvant treatment.
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •All cohorts:
- •Patients will not be included in the study if one or more of the following criteria applies:
- •-Patient is pregnant
- •-Patient is breast feeding
- •-Patient with recent (< 1 week) gastrointestinal disorders with diarrhea as major symptom
- •-Patient with any serious active infection
- •-Patient who has any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the test radiopharmaceutical
- •-Patient who cannot communicate reliably with the investigator
- •-Patient who is unlikely to cooperate with the requirements of the study
- •-Patient who is unwilling and/or unable to give informed consent
- •-Patient at increased risk of death from a pre-existing concurrent illness
- •-Patient who participated already in this study. (cohort 1 and 3)
研究者
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已完成
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