KCT0007035招募中未知
PET imaging of Non-Hodgkin’s Lymphoma using 64Cu-DOTA-Rituximab for pharmacokinetics study: Microdose PET clinical trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19?(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •# Non-Hodgkin lymphoma patients
- •1. Histologically diagnosed CD-20 positive B-cell non-Hodgkin's lymphoma
- •- At least one measurable lesion
- •2. Able to provide informed consent and have signed an approved consent form that conforms to institutional guidelines to ensure compliance
- •3, Subjects with age =/> 19 years
- •4. ECOG (Eastern Cooperative Oncology Group) Performance scale =2
- •5. The life expectancy of greater than or equal to 12 months.
- •6. Those who satisfy the following conditions in a blood test
- •- Absolute neutrophil count (ANC) = 1,500/µL
- •- Platelet count (PLT) = 100,000 / µL
- •- Blood Urea Nitrogen (BUN) and serum creatine < 1.5 x upper normal limit (ULN)
- •- AST (aspartate transaminase) and ALT (alanine aminotransferase) < 5 x upper normal limit (ULN)
- •7. In the case of patients who have recently received chemotherapy, radiation therapy, immunosuppressive drugs, or cytokine therapy, those who have passed 4 weeks or more from the date of last administration or irradiation
排除标准
- •1. A person who is judged to be difficult to perform a clinical trial due to a serious medical condition
- •2. The person who is determined to have a mental disorder that is difficult to perform PET (Positron Emission Tomography) scan
- •3. Pre-menopausal women who are pregnant or lactating at screening, or planning to become pregnant during the clinical trial period
- •4. Those who are participating in other clinical trials at screening and whose clinical trials may affect the acquisition of 18F-FDG or 64Cu-DOTA-Rituximab PET images during screening (e.g., simply follow-up not receiving investigational drugs at screening If you are participating in other cohort clinical trials, you can participate in the current clinical trial)
- •5. Those participating in other clinical trials at screening and participating in clinical trials should be able to influence the acquisition of 18F-FDG or 64Cu-DOTA-Rituximab PET (Positron Emission Tomography) images from the time of registration until the end of the study, or that may affect the safety assessment following intravenous injection of 18F-FDG or 64Cu-DOTA-Rituximab (For example, if you are participating in another cohort-based trial that is simply focused on monitoring that you do not receive medicines during screening, you can participate in the current clinical trials.)
- •6. Those who have the potential to influence the acquisition of 18F-FDG PET images due to unadjusted diabetes
- •7. Any other person who is deemed not to be eligible to participate in the trial
- •8. Vulnerable subjects (researchers or students who participated in the research, family members, researchers or students of researchers participating in research)
- •9. Subject with obstructive hydronephrosis
- •10. Subject with infections requiring intravenous antibiotic treatment
- •11. HAMA (Human Anti-murine Antibody) positive
研究者
相似试验
未知
不适用
64Cu-DOTA-nivolumab PET imaging in patients with malignant melanoma or non-small cell lung cancer.nresectable or metastatic malignant melanoma,unresectable or metastatic non small cell lung cancerJPRN-UMIN000026658ational Cancer Center Hospital, Tokyo, Japan50
招募中
不适用
PET imaging of breast cancer using 64Cu-NOTA-Trastuzumab for pharmacokinetics study: Microdose PET clinical trialKCT0002790Korea Cancer Center Hospital6
进行中（未招募）
1 期
Combined 64Cu-DOTATATE and 18F-FDG PET/CT Imaging in Patients with Neuroendocrine Tumorseuroendocrine neoplasmsMedDRA version: 21.0Level: LLTClassification code 10062476Term: Neuroendocrine tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10057270Term: Neuroendocrine carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: LLTClassification code 10068916Term: Pancreatic neuroendocrine tumor metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10071542Term: Neuroendocrine carcinoma metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10077560Term: Gastroenteropancreatic neuroendocrine tumor diseaseSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: LLTClassification code 10067518Term: Pancreatic neuroendocrine tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 24.1Level: LLTClassification code 10085846Term: Duodenal neuroendocrine tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 24.1Level: LLTClassification code 10085958Term: Small intestine neuroendocrine tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2021-005919-30-DKDepartment of Clinical Physiology and Nuclear Medicine, Rigshospitalet200
招募中
不适用
PET imaging of breast cancer using 64Cu-DOTA-Trastuzumab for evaluating HER2 expression: Investigator Initiated TrialsKCT0002791Korea Cancer Center Hospital30
招募中
不适用
Feasibility study of PET Imaging with 64Cu-DOTA-trastuzumab in HER2 positive breast cancer1. Patients with invasive ductal carcinoma of breast. 2. HER2 positive (IHC 3+>or FISH positive) breast cancer 3. Currently taking or about to commence treatment with trastuzumab or trastumab based chemotherapy 4. Age: >20 years, <75 years 5. ECOG Performance Score 0 or 1. 6. Good main organ function 7. Capability to be received PET scan. 8. Signed informed consentJPRN-UMIN000004170ational Cancer Center Hospital40