NIPH Clinical Trials Search

5-ALA PDD STS

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Soft tissue sarcoma
Date of first enrollment	01/05/2026
Target sample size	28
Countries of recruitment
Study type	Interventional
Intervention(s)	Administer 20 mg/kg of aminolevulinic acid hydrochloride orally, dissolved in water 2-8 hours prior to induction of anesthesia.

Outcome(s)

Primary Outcome	Sensitivity of biopsy tissue specimens under blue light excitation in soft tissue sarcomas
Secondary Outcome	Specificity of biopsy tissue specimens under blue light excitation in benign soft tissue tumors, Sensitivity depending on histology, Adverse events (Safety)

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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
Exclude 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.