EUCTR2014-003027-21-AT进行中（未招募）1 期
Open-label, multi center PET/CT (positron emission tomography/computed tomography) study for investigation of safety and diagnostic performance of the 68Ga labeled PET tracer [68Ga]RM2 following a single intravenous administration of 140 MBq (corresponding to = 40µg mass dose) in patients with primary prostate cancer - PET/CT imaging for safety and diagnostic performance of [68Ga]RM2 in patients with primary prostate
Piramal Imaging SA0 个研究点目标入组 80 人开始时间: 2015年2月18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
- 80
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
- Male
入选标准
- •1.Written informed consent.
- •2.Males = 45 years of age.
- •3.Patients with primary prostate cancer in which prostate cancer is histologically confirmed and results of histology are available.
- •4.Patient with planned prostatectomy (within 4 weeks following the [68Ga]RM2 scan).
- •5.Patient had a MRI, and [18F]-choline PET/CT (when available), for primary detection or staging and the images and the results are available (Note: [18F]-choline PET/CT is optional) or the MRI examination is already scheduled at the time of the screening visit for a date before prostatectomy.
- •6.The MRI and [18F]-choline PET/CT referred to in criterion 5 were performed preferably within not more than 5 days prior to the planned imaging with [68Ga]RM2. The maximum interval between MRI and [18F]-choline PET/CT and treatment with [68Ga]RM2 PET/CT is 6 weeks. However, if required, the MRI examination can also be performed after the [68Ga]RM2 PET/CT, but is already scheduled at the time of the screening visit for a date before prostatectomy.
- •7.No chemotherapy, radiotherapy, biopsy or immune/biologic therapy between MRI and [18F]-choline PET/CT (when performed) and [68Ga]RM2 PET/CT performed or scheduled. NOTE: If MRI is performed after the [68Ga]RM2 PET/CT, no chemotherapy, radiotherapy, biopsy or immune/biologic therapy between [68Ga]RM2 PET/CT and MRI examination is allowed.
- •8.Recovery (excluding alopecia) from previous surgery, radiation, and chemotherapy
- •9.ECOG (Eastern Cooperative Oncology Group) performance status of 0-2 (see Attachments).
- •10.Confirmation of adequate function of major organs and systems.
- •11.No clinically relevant deviations in renal function as determined by Cockcroft and Gault method using serum creatinine at screening.
- •12.No malfunction equivalent to CTC (Common toxicity criteria) toxicities grade > 2 of the liver (ALT; bilirubin).
- •13.Life expectancy of at least 3 months.
- •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 55
- •1.Written informed consent.
- •2.Males = 45 years of age.
- •3.Patients with primary prostate cancer in which prostate cancer is histologically confirmed and results of histology are available.
- •4.Patient with planned prostatectomy (within 4 weeks following the [68Ga]RM2 scan).
- •5.Patient had a MRI, and [18F]-choline PET/CT (when available), for primary detection or staging and the images and the results are available (Note: [18F]-choline PET/CT is optional) or the MRI examination is already scheduled at the time of the screening visit for a date before prostatectomy.
- •6.The MRI and [18F]-choline PET/CT referred to in criterion 5 were performed preferably within not more than 5 days prior to the planned imaging with [68Ga]RM2. The maximum interval between MRI and [18F]-choline PET/CT and treatment with [68Ga]RM2 PET/CT is 6 weeks. However, if required, the MRI examination can also be performed after the [68Ga]RM2 PET/CT, but is already scheduled at the time of the screening visit for a date before prostatectomy.
- •7.No chemotherapy, radiotherapy, biopsy or immune/biologic therapy between MRI and [18F]-choline PET/CT (when performed) and [68Ga]RM2 PET/CT performed or scheduled. NOTE: If MRI is performed after the [68Ga]RM2 PET/CT, no chemotherapy, radiotherapy, biopsy or immune/biologic therapy between [68Ga]RM2 PET/CT and MRI examination is allowed.
- •8.Recovery (excluding alopecia) from previous surgery, radiation, and chemotherapy
- •9.ECOG (Eastern Cooperative Oncology Group) performance status of 0-2 (see Attachments).
- •10.Confirmation of adequate function of major organs and systems.
- •11.No clinically relevant deviations in renal function as determined by Cockcroft and Gault method using serum creatinine at screening.
- •12.No malfunction equivalent to CTC (Common toxicity criteria) toxicities grade > 2 of the liver (ALT; bilirubin).
- •13.Life expectancy of at least 3 months.
- •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 55
- •1.Written informed consent.
- •2.Males = 45 years of age.
- •3.Patients with primary prostate cancer in which prostate cancer is histologically confirmed and results of histology are available.
- •4.Patient with planned prostatectomy (within 4 weeks following the [68Ga]RM2 scan).
- •5.Patient had a MRI, and [18F]-choline PET/CT (when available), for primary detection or staging and the images and the results are available (Note: [18F]-choline PET/CT is optional) or the MRI examination is already scheduled at the time of the screening visit for a date before prostatectomy.
- •6.The MRI and [18F]-choline PET/CT referred to in criterion 5 were performed preferably within not more than 5 days prior to the planned imaging with [68Ga]RM2. The maximum interval between MRI and [18F]-choline PET/CT and treatment with [68Ga]RM2 PET/CT is 6 weeks. However, if required, the MRI examination can also be performed after the [68Ga]RM2 PET/CT, but is already scheduled at the time of the screening visit for a date before prostatectomy.
- •7.No chemotherapy, radiotherapy, biopsy or immune/biologic therapy between MRI and [18F]-choline PET/CT (when performed) and [68Ga]RM2 PET/CT performed or scheduled. NOTE: If MRI is performed after the [68Ga]RM2 PET/CT, no chemotherapy, radiotherapy, biopsy or immune/biologic therapy between [68Ga]RM2 PET/CT and MRI examination is allowed.
- •8.Recovery (excluding alopecia) from previous surgery, radiation, and chemotherapy
- •9.ECOG (Eastern Cooperative Oncology Group) performance status of 0-2 (see Attachments).
- •10.Confirmation of adequate function of major organs and systems.
- •11.No clinically relevant deviations in renal function as determined by Cockcroft and Gault method using serum creatinine at screening.
- •12.No malfunction equivalent to CTC (Common toxicity criteria) toxicities grade > 2 of the liver (ALT; bilirubin).
- 另有 7 项未显示
排除标准
- •1.Concurrent severe and/or uncontrolled and/or unstable medical disease other than prostate cancer (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of [68Ga]RM2, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study.
- •2.Known sensitivity to the study drug or components of the preparation.
- •3.Patient is in custody by order of an authority or a court of law.
- •4.Patient is a relative of the investigator, student of the investigator or otherwise dependent.
- •5.Patient is participating in another clinical study involving administration of an investigational drug at the same time as well as in the preceding 4 weeks before radiotracer administration. Participation in another clinical study involving administration of an investigational drug has ended within the preceding 4 weeks before radiotracer administration.
- •6.Unwillingness or inability to comply with the protocol.
- •7.Patient fulfils criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the patient’s safety.
- •8.Hematological or biochemical parameters that are outside the normal range and are considered clinically significant by the investigator, i.e. CTC (Common toxicity criteria) toxicities grade > 2. Minor deviations in lab parameters that are considered by the evaluating physician to be not clinically significant with respect to safety or interpretation of study results are not considered an exclusion criterion.
- •9.History of significant occupational exposure to ionizing radiation or monitoring of occupational radiation exposure (according to recommendations from current guidelines).
- •10.Donation of blood within 12 weeks or plasmapheresis within 2 weeks before the radiotracer administration.
- •1.Concurrent severe and/or uncontrolled and/or unstable medical disease other than prostate cancer (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of [68Ga]RM2, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study.
- •2.Known sensitivity to the study drug or components of the preparation.
- •3.Patient is in custody by order of an authority or a court of law.
- •4.Patient is a relative of the investigator, student of the investigator or otherwise dependent.
- •5.Patient is participating in another clinical study involving administration of an investigational drug at the same time as well as in the preceding 4 weeks before radiotracer administration. Participation in another clinical study involving administration of an investigational drug has ended within the preceding 4 weeks before radiotracer administration.
- •6.Unwillingness or inability to comply with the protocol.
- •7.Patient fulfils criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the patient’s safety.
- •8.Hematological or biochemical parameters that are outside the normal range and are considered clinically significant by the investigator, i.e. CTC (Common toxicity criteria) toxicities grade > 2. Minor deviations in lab parameters that are considered by the evaluating physician to be not clinically significant with respect to safety or interpretation of study results are not considered an exclusion criterion.
- •9.History of significant occupational exposure to ionizing radiation or monitoring of occupational radiation exposure (according to recommendations from current guidelines).
- •10.Donation of blood within 12 weeks or plasmapheresis within 2 weeks before the radiotracer administration.
- •1.Concurrent severe and/or uncontrolled and/or unstable medical disease other than prostate cancer (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of [68Ga]RM2, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study.
- •2.Known sensitivity to the study drug or components of the preparation.
- •3.Patient is in custody by order of an authority or a court of law.
- •4.Patient is a relative of the investigator, student of the investigator or otherwise dependent.
- •5.Patient is participating in another clinical study involving administration of an investigational drug at the same time as well as in the preceding 4 weeks before radiotracer administration. Participation in another clinical study involving administration of an investigational drug has ended within the preceding 4 weeks before radiotracer administration.
- •6.Unwillingness or inability to comply with the protocol.
- •7.Patient fulfils criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the patient’s safety.
- •8.Hematological or biochemical parameters that are outside the normal range and are considered clinically significant by the investigator, i.e. CTC (Common toxicity criteria) toxicities grade > 2. Minor deviations in lab parameters that are considered by the evaluating physician to be not clinically significant with respect to safety or interpretation of study results are not considered an exclusion criterion.
- •9.History of significant occupational exposure to ionizing radiation or monitoring of occupational radiation exposure (according to recommendations from current guidelines).
- •10.Donation of blood within 12 weeks or plasmapheresis within 2 weeks before the radiotracer administration.
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