Unique ID issued by UMIN | UMIN000018386 |
---|---|
Receipt number | R000021289 |
Scientific Title | Development of New Diagnostic Method of Sentinel Lymph Nodes and Surgical Margins Using 5-Aminolevulinic Acid in Breast Cancer Patients. |
Date of disclosure of the study information | 2015/07/22 |
Last modified on | 2018/10/10 12:57:29 |
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.
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.
Japan |
Breast cancer
Breast surgery |
Malignancy
NO
Sentinel lymph node (SLN) biopsy is a common diagnostic method in breast cancer surgery. To diagnose SLNs and surgical margins immediately, frozen pathological diagnosis is mandatory. In this study, we will develop a easier and more rapid diagnostic method using 5-aminolevulinic acid (5-ALA) in breast cancer surgery.
Safety,Efficacy
Confirmatory
Pragmatic
Phase I,II
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.
To check the matching rate between 5-ALA method and rapid or permanent pathological diagnosis of surgical margins in breast conserving therapy.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Diagnosis
Medicine |
5-aminolevulinic acid
20 | years-old | <= |
Not applicable |
Female
1. Age older than 20 years
2 .Diagnosed with operable breast cancer
3. Informed consent is signed
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
130
1st name | |
Middle name | |
Last name | Tetsuya Taguchi |
Kyoto Prefectural University of Medicine
Endocrine & Breast Surgery
465 Kajii-cho,Kawaramachi-Hirokoji,Kamigyo-ku,Kyoto
+81-75-251-5534
ksak@koto.kpu-m.ac.jp
1st name | |
Middle name | |
Last name | Koichi Sakaguchi |
Kyoto Prefectural University of Medicine
Endocrine & Breast Surgery
465 Kajii-cho,Kawaramachi-Hirokoji,Kamigyo-ku,Kyoto
+81-75-251-5534
ksak@koto.kpu-m.ac.jp
Kyoto Prefectural University of Medicine
MEXT KAKENHI Grant
Other
Ushio inc.
NO
京都府立医科大学附属病院
2015 | Year | 07 | Month | 22 | Day |
Published
Completed
2015 | Year | 06 | Month | 24 | Day |
2015 | Year | 08 | Month | 01 | Day |
2015 | Year | 07 | Month | 22 | Day |
2018 | Year | 10 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021289
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |