Dose finding study for deciding the optimal dose of fluorescein during probe based confocal endomicroscopy

Dose finding study for deciding the optimal dose of fluorescein during probe based confocal endomicroscopy - Dose finding study of fluorescein for pCLE

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000027696

Enrollment

Registered

2017-06-12

Start date

2017-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastrointestinal cancer

Interventions

Single dose adminstration of fluorescein to perform pCLE

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who are scheduled to perform endoscopic resection or surgery for gastrointestinal tumors. Written informed consent is obtained. Laboratory data within 90 days before registration meet the criteria.

Exclusion criteria

Exclusion criteria: Contraindication to biopsy. Patients who can not stop anticoagulants. Allergy to fluorescein. Patients who have the history of pheochromocytoma, malignant hypertension, severe heart failure, myocardial infarction that has occured with in 3 months, uncontrolled diabetes, severe pulmonary fibrosis, active interstitial pneumonia, uncontrolled infection. Pregnant. Others who are judged as inappropriate by medical doctors.

Design outcomes

Primary

Measure	Time frame
Visibility of duodenal or colon mucosa that is examined by pCLE with using different dose of fluorescein.	—

Secondary

Measure	Time frame
Adverse event with different dose of fluorescein.	—

Countries

Japan

Contacts

Public ContactKazuya Inoki

National Cancer Center Hospital Endoscopy Division

kinoki@ncc.go.jp03-3542-2511

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026