Development of New Diagnostic Method of Sentinel Lymph Nodes and Surgical Margins Using 5-Aminolevulinic Acid in Breast Cancer Patients.

Development of New Diagnostic Method of Sentinel Lymph Nodes and Surgical Margins Using 5-Aminolevulinic Acid in Breast Cancer Patients. - Diagnosis of Sentinel Lymph Nodes and Surgical Margins Using 5-Aminolevulinic Acid in Breast Cancer Patients.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000018386

Enrollment

130

Registered

2015-07-22

Start date

2015-08-01

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

Breast cancer

Interventions

5-aminolevulinic acid

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Age older than 20 years 2 .Diagnosed with operable breast cancer 3. Informed consent is signed

Exclusion criteria

Exclusion criteria: 1. Porphyria 2. With history of hypersensitivity reaction for 5-aminolevulinic acid or porphyrin 3. For whom drugs that can cause photosensitivity disease is needed 4. Apparently or possibly pregnant or have desire to be come pregnant 5. Cases who physician judged improper to entry this trial

Design outcomes

Primary

Measure	Time frame
To confirm the safety of 5-ALA and the performance of the measuring instrument. To check the matching rate between 5-ALA method and rapid or permanent pathological diagnosis of SLNs.	—

Secondary

Measure	Time frame
To check the matching rate between 5-ALA method and rapid or permanent pathological diagnosis of surgical margins in breast conserving therapy.	—

Countries

Japan

Contacts

Public ContactKoichi Sakaguchi

Kyoto Prefectural University of Medicine Endocrine & Breast Surgery

ksak@koto.kpu-m.ac.jp+81-75-251-5534

Outcome results

None listed

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