EUCTR2020-003932-26-AT进行中（未招募）1 期
Phase I/IIa study to evaluate the safety, tolerability, whole-body distribution, and preliminary diagnostic performance of a novel 68Ga-labelled minigastrin analogue in patients with advanced neuroendocrine tumours
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 12
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
- •- =18 years, men and women
- •- Understanding and provision of signed and dated written informed consent by the patient or legally acceptable representative prior to any study-specific procedures
- •- Karnofsky performance status >70
- •- Histopathologically diagnosed locally advanced or metastatic MTC with calcitonin level >100 pg/mL after total thyroidectomy or other histologically
- •diagnosed gastroenteropancreatic and bronchopulmonary NET with known metastases
- •- Patients with an advanced stage of disease as documented by local or distant metastasis in alternative imaging procedure such as 68Ga-SSTR-PET/CT or 18FDOPA-PET/CT, including a contrast enhanced CT performed up to six months before study inclusion
- •- Male subjects must-agree to use condoms throughout the study period and for 1 month after study termination if their partner is of childbearing potential and is using no contraception. They agree not to donate semen during the study period and for 1 month after study termination.
- •- Women of childbearing potential (WOCBP) must have a negative urine/serum pregnancy test. WOCBP who are sexually active, agree to use highly-effective means of contraception during the study period and for at least 6 months poststudy treatment. Allowed are accepted and effective non-hormonal methods of contraception and sexual abstinence or vasectomised partners (>3 months previously). Vasectomy has to be confirmed by two negative semen analyses.
- •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 6
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •- Other known co-existing malignancies except patients with a history of malignant tumours in complete remission >3 years, with no evidence of recurrence <5 years
- •- Participation in any other investigational trial within 3 months of study entry
- •- Treatment with tyrosine kinase inhibitors within 1 month before study entry
- •- Organ allograft requiring immunosuppressive therapy
- •- Renal insufficiency with an eGFR <30 mL/min/1.72m2
- •- Higher than grade 2 hematotoxicity (CTC >2)
- •- Clinically abnormal ECG (signs of ischemia, high grade ventricular arrhythmia, high grade supraventricular arrhythmia)
- •- Pregnancy, breast-feeding
- •- Patients with concurrent illnesses or severe infectious diseases that might preclude study completion
- •- Patients with bladder outflow obstruction or unmanageable urinary incontinence
- •- Known hypersensitivity to Gallium-68 or to any of the excipients of DOTA-MGS5
- •- Any condition that precludes raised arms position for prolonged imaging purposes
- •- Prior administration of a radiopharmaceutical within a period corresponding to 8 half-lives of the radionuclide used on such radiopharmaceutical
- •- Clinically significant illness or clinically relevant trauma within 3 weeks before the administration of the investigational product
- •- Persons with any kind of dependency on the investigator or employed by the sponsor or investigator
- •- Persons held in an institution by legal or official or
研究者
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