Photodynamic diagnosis using 5-ALA for biliary pancreatic cancer

JRCT ID: jRCTs061210042

Registered date:13/10/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Biliary pancreatic cancer
• Date of first enrollment: 28/03/2022
• Target sample size: 62
• Study type: Interventional
• Intervention(s): Aminolevulinic acid hydrochloride administration

Outcome(s)

• Primary Outcome: Detection sensitivity, specificity, positive predictive rate and negative predictive rate of biliary tract cancer and pancreatic cancer evaluated by a high-resolution liquid crystal LCTF microscope with biopsy tissue

Secondary Outcome

1) Detection sensitivity, specificity, positive predictive rate and negative predictive rate of biliary tract cancer and pancreatic cancer evaluated by a high-resolution liquid crystal LCTF microscope with biopsy tissue, bile and pancreatic juice
2) Detection rate and wavelength of biliary pancreatic mass evaluated by high-resolution liquid crystal LCTF microscope with biopsy tissue
3) Porphyrin metabolite concentration in bile and pancreatic juice
4) Changes in porphyrin metabolite concentration in blood and urine
5) Adverse event

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

[5ALA group]
1) 20 or above years old male or female
2) Patients who require endoscopic pathological diagnosis in usual care as a detailed examination of biliary pancreatic cancer
3) Patients who agreed to administer 5-ALA as a study drug
4) Patients with preserved heart, lung, liver and kidney function
5) Patients who received written consent from the study subject

[Non 5ALA group]
1) 20 or above years old male or female
2) Patients who require endoscopic pathological diagnosis in usual care as a detailed examination of biliary pancreatic cancer
3) Patients with preserved heart, lung, liver and kidney function
4) Patients who received written consent from the study subject

Exclude criteria

[5ALA group]
1) Patients with a history of hypersensitivity to 5-ALA or porphyrin
2) Porphyria patients
3) Patients who need to take medicines or foods known to cause photosensitivity within 48 hours after administration of study drug from admission.
4) Patients with absolute contraindications to endoscopy
5) Pregnant women or patients who may be pregnant
6) Patients who cannot ingest
7) Patients who cannot be properly shielded 48 hours postdose
8) Patients who received drug treatment for malignant tumor within 1 month before obtaining consent
9) Patients who received study drug within 3 months before study drug administration

[Non 5ALA group]
1) Patients with absolute contraindications to endoscopy
2) Pregnant women or patients who may be pregnant
3) Patients who received drug treatment for malignant tumor within 1 month before obtaining consent
4) Patients who received study drug within 3 months before study drug administration

Related Information

• Primary Sponsor: Isomoto Hajime