A Phase III Study for Modification of Photodynamic Diagnosis of SPP-005

JRCT ID: jRCT2061210055

Registered date:03/12/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Non-muscle Invasive Bladder Cancer
• Date of first enrollment: 12/01/2022
• Target sample size: 106
• Study type: Interventional

Intervention(s)

Before TURBT, 20 mg/kg of aminolevulinic acid hydrochloride is dissolved in water and administered orally according to the assigned stratum dosing time.
-Stratum 1:Oral dose, 5 hours before TURBT(4 < t <= 6 hours)
-Stratum 2:Oral dose, 7 hours before TURBT(6 < t <= 8 hours)

Outcome(s)

• Primary Outcome: Proportion of biopsy samples diagnosed as positive under BL out of the biopsy samples confirmed pathologically positive those collected during TURBT when SPP-005 administrates 4-8 hours before inserting the cystoscope (sensitivity).

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 85age old
• Gender: Both

Include criteria

1)Patients who are eligible for TURBT
2)Patients who understand the informed consent document and can provide a written consent of their own free will
3)Patients who are between 20 and 85 years old (at the time of signing the informed consent document)
4)Patients with an ECOG Performance Status (ECOG PS) of 0 to 1 as determined at the time of enrollment
5)Patients whose clinical laboratory values meet the following criteria (laboratory tests within 28 days prior to IMP administration)
[Renal function]
Serum creatinine: Less than 1.5 times the upper limit of the institutional standard
[Hepatic function]
AST (GOT): Less than 1.5 times the upper limit of the institutional standard
ALT (GPT): Less than 1.5 times the upper limit of the institutional standard
Serum bilirubin: Less than 1.5 times the upper limit of the institutional standard
[Blood]
Platelet count:100,000/mm3 or more
6)Patients who are able to comply with the requirements of the study protocol, including the schedule of visit days
7)Patients suspected of having NMIBC, whether primary or recurrent, and in case of recurrence parents, at least 90 days have passed since the last day of the bladder cancer treatment.

Exclude criteria

1)Patients with a history of or complications from any of the following
-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 active multiple cancers
5)Patients with systolic blood pressure of 100 mmHg or less, or diastolic blood pressure of 60 mmHg or less on the screening examination
6)Patients with a history of hypotension during previous TURBT
7)Female patients who are pregnant, lactating, or may be pregnant
8)Patients who do not intend to use contraception*
9)Patients with hypersensitivity or a history of hypersensitivity to porphyrin analogs.
10)Patients who have received any investigational medical product (including study drugs in post-marketing clinical studies) within 90 days prior to the start of screening examination
11)Patients who are scheduled to participate in clinical trials, etc. during the clinical trial period
12)Other patients who are judged to be inappropriate by the principal or sub investigators.
* Examples of contraception methods: condom, intrauterine device (IUD) and oral contraceptives (if a female participant use an oral contraceptive, a barrier method must be used concurrently).

Related Information

• Primary Sponsor: Yamauchi Mitsugu