Development of Photodynamic diagnosis for oral cancer and the navigation system during surgery.

Development of Photodynamic diagnosis using 5-ALA for oral cancer and the navigation system during surgery. - Photodynamic diagnosis using 5-ALA for detection of oral cancer.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000041592

Enrollment

Registered

2020-08-28

Start date

2014-06-01

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

Oral cancer, Oral precancerous lesion

Interventions

After the topical application of 1% aminolevurinic acid solution for 1-1.5 hour, oral lesions are observed by the novel PDD system, judged whether oral lesions emit red fluorescence and then compared

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients have suspicious oral cancer and receive a biopsy and resection of oral lesion. 2)Patients sign informed conscent.

Exclusion criteria

Exclusion criteria: 1)Patients with Porphria and photosensitivity 2)Patients with serious medical history(renal insufficiency, hepatic insufficiency) 3)Patients with serious mental disorder 4)Pregnant women or nursing mother. 5)Patients judged to be inappropriate to participate this study by the examiners.

Design outcomes

Primary

Measure	Time frame
Sensitivity, specificity, positive predictive value, and negative predictive value for detection of oral cancer and precancerous lesion by comparing the results of ALA-PDD with histopathological diagnosis.	—

Secondary

Measure	Time frame
incidence rate of adverse events	—

Countries

Japan

Contacts

Public ContactSeiko Tatehara

Tsurumi University Dental Hospital. Department of Oral Medicine

tatehara-s@tsurumi-u.ac.jp045-580-8389

Outcome results

None listed

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