Soft tissue sarcoma Soft tissue sarcoma
Conditions
Sponsors
Nakamura Tomoki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Soft tissue tumors at extrimities or trunk 2) Unknown pathological diagnosis 3) Patients who are 18 and older (at the time of signing the informed consent document) 4) Good general condition for receiving open biopsy 5) Patients who obtained informed consent
Exclusion criteria
Exclusion criteria: 1) Patients with a history of or complications from any of the following conditions: - Myocardial infarction - Congestive heart failure - Angina pectoris requiring treatment - Arrhythmia requiring treatment 2) Patients with serious complications (interstitial pneumonia, pulmonary fibrosis, poorly controlled hypertension, diabetes mellitus, etc.) 3) Patients with serious infectious diseases (including active tuberculosis) 4) Patients with multiple active malignancies 5) Patients whose clinical laboratory values meet the following criteria (laboratory tests within 28 days before tthe administration of aminolevulinic acid hydrochloride) [Renal function] Serum creatinine: Less than 3 times the upper limit of the institutional standard [Hepatic function] AST: Less than 3 times the upper limit of the institutional standard ALT: Less than 3 times the upper limit of the institutional standard Serum bilirubin: Less than 1.5 times the upper limit of the institutional standard 6) Patients with systolic blood pressure of 90 mmHg or less, or diastolic blood pressure of 50 mmHg or less on the screening examination 7) Patients with hypersensitivity or a history of hypersensitivity to porphyrin analogs 8) Female patients who are pregnant, lactating, or may be pregnant 9) Patients with hypersensitivity or a history of hypersensitivity to porphyrin analogs 10) Patients who have received unapproved or off-label drugs in other clinical trials, etc. within 90 days prior to administration of the investigational drug, and patients who are scheduled to participate in clinical trials, clinical research, etc. (including advanced medical care) during the trial period 11) Patients with porphyria 12) Patients who have received cancer chemotherapy within 21 days prior to administration of the study drug or who have undergone resection of cancer within 21 days prior to administration of the study drug 13) Other patients who are judged to be inappropriate by the principal or sub-investigators. 14) Tumor size less than 5 cm.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity of biopsy tissue specimens under blue light excitation in soft tissue sarcomas | — |
Secondary
| Measure | Time frame |
|---|---|
| Specificity of biopsy tissue specimens under blue light excitation in benign soft tissue tumors, Sensitivity depending on histology, Adverse events (Safety) | — |
Contacts
Public ContactTomoki Nakamura
Mie University Hospital
Outcome results
None listed