Clear cell renal cell carcinoma
Conditions
Interventions
Single intravenous administration of 148 MBq of 64Cu-PD-32766
Sponsors
Inaki Anri
Peptidream Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) proven clear cell renal cell carcinoma. 2) The presence of any of the following lesions can be confirmed by imaging examinations (CT, MRI): Distant metastatic lesions (including distant metastatic recurrence) Local recurrence lesions from the site of removal after total nephrectomy of the diseased kidney 3) satisfying the following within 28 days before registration: 3)-1 hematopoietic function neutrophil >= 1,500 /microL (G-CSF independent) platelets >= 100,000 /microL (transfusion independent) Hb >= 8.0 g/dL (transfusion independent) 3)-2 renal function eGFR >= 30 mL/min/1.73m2 3)-3 hepatic function ALT = 96% (at room air) 4) ECOG PS 0 or 1 within 28 days before registration. 5) 18-year-old and more person. 6) written informed consent to participate in the current clinical trial.
Exclusion criteria
Exclusion criteria: 1) current malignancies other than clear cell renal cell carcinoma. 2) HBV (or carrier), HCV, HIV, or any other active infections which need to be treated during the current trial. 3) any of the following conditions / diseases of poor control. symptomatic congestive heart failure, unstable angina, myocardial infarction, arrythmia, any valvular diseases, any aortic disorders, respiratory disorders (which need to medications or physical treatment such as oxygen administration, continuous positive pressure breathing therapy), interstitial pulmonary disorder, pleural effusion, ascites, hemorrhagic diathesis (e.g., hemophilia, idiopathic thrombocytopenic purpura, antiplatelet therapy, anticoagulant therapy), diabetes mellitus (HbA1c >=8.0%) 4) current poorly-controlled psychiatric disorder. 5) pregnant, potentially pregnant, or breastfeeding woman. 6) difficulty in complying with the instructions of the investigator in the radiation-controlled area. 7) possibility of administration of radiopharmaceuticals other than the study drug. 8) history of administration of 64Cu-PD-32766 9) any other reasons that the patient cannot participate in the current clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| per-patient PET sensitivity | — |
Secondary
| Measure | Time frame |
|---|---|
| per-lesion PET sensitivity, safety, pharmacokinetics, estimated irradiation dose | — |
Contacts
Public ContactAnri Inaki
National Cancer Center Hospital East
Outcome results
None listed