malignant renal tumor
Conditions
Interventions
A radiofrequency needle is inserted into the renal tumor percutaneously, and then, radiofrequency tumor ablation is performed.
Sponsors
Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or imaging confirmed malignant renal tumor. 2) Having at least one target lesion with maximum diameter on CT image between 1.0cm and 3.cm. 3) Target lesion shows the increase of HU more than 20 on CT by contrast enhacement. 4) Surgical treatment is out of indication or refused. ous loco-regional therapy for the tumor. 5) Adequate cardiac, hepatic, renal, respiratory, coagulation, and bone marrow functions. 6) Age less than 20 at informed consent. 7) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 8) Expected survival more than 2 months. 9) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Cardiac pacemaker. 2) Artery, nerve or ureter exists on the puncture route. 3) Target lesion adjacent to renal pelvis, or a RFA needle can not be inserted without passing through renal pelvis or alimentary tract. 4) Non-mesurable target lesion on CT. 5) Colinically significant bleeding tendency or abnormal coagulation. 6) Tentative stop of anti-platelet or anti-coagulant medication is not allowed. 7) Drug allergy 8) With active infection 9) With active inflammation 10) Fever above 38 degrees Celsius. 11) If having multiple lesions, no treatment of tumors except a target lesion for 4 weeks after the treatment for a target lesion is not allowed. 12) Stop of chemotherapy or immunotherapy for 4 weeks after the treatment for a target lesion is not allowed. 13) Previous reginal therapy for the target lesion. 14) Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate of tumor shrinkage on RECIST | — |
Countries
Japan
Contacts
Public ContactYasuaki Arai
JIVROSG, Coordinating Office Division of Diagnostic Radiology, National Cancer Center Hospital
Outcome results
None listed