ALA-CPM

JRCT ID: jRCTs031200038

Registered date:28/05/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: peritoneal metastasis from colorectal cancer
• Date of first enrollment: 28/05/2020
• Target sample size: 20
• Study type: Interventional
• Intervention(s): 3-4 hours before the operation, 1.5 g (20 mg / kg) of araglio granules was dissolved in 50 ml of water and orally administered. Under general anesthesia and insufflation of carbon dioxide gas, the inside of the abdominal cavity is observed using a white and fluorescent light source device. The presence or absence of fluorescence is evaluated using normal light (white light) and blue light.

Outcome(s)

• Primary Outcome: ALA-PDD increases the accuracy of peritoneal metastasis (Comparison of sensitivity between white light and blue light)
• Secondary Outcome: Safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

1) Patient diagnosed or suspiciously as peritoneal metastasis from colorectal cancer
2) Patient aged from 20 to 75 years
3) Patient with ECOG performance status of 0 or 1

Exclude criteria

1) Porphyria. Patients with a history of sun or photosensitivity.
2) Patients with a history of hypersensitivity to porphyrins.
3) Patients taking drugs that may induce photosensitivity.
4) In addition, patients whose physician judged that participation in this study was inappropriate.

Related Information

• Primary Sponsor: Gohda Yoshimasa
• Source(s) of Monetary Support: National Center for Global Health and Medicine