UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012251
Receipt number R000014323
Scientific Title An exploratory study to developing breast cancer diagnostic method using wide viewing angle photoacoustic mammography.
Date of disclosure of the study information 2013/11/08
Last modified on 2020/03/18 16:33:09

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Basic information

Public title

An exploratory study to developing breast cancer diagnostic method using wide viewing angle photoacoustic mammography.

Acronym

An exploratory study of photoacoustic mammography

Scientific Title

An exploratory study to developing breast cancer diagnostic method using wide viewing angle photoacoustic mammography.

Scientific Title:Acronym

An exploratory study of photoacoustic mammography

Region

Japan


Condition

Condition

Breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To study clinical usefulness of photoacoustic mammography in breast cancer diagnosis by evaluating photoacoustic images using wide viewing angle photoacoustic mammography.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Photoacoustic images using wide viewing angle photoacoustic mammography.

Key secondary outcomes

Frequency of adverse events of photoacoustic mammography


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Photoacoustic Mammography

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

1. Patients who have benign or malignant tumors within the breast
2. Patients whose performance status are 0 or 1
3. Female patients who can agree to participate in this study of their own will, and aged 20 years and older at the time of informed consent

Key exclusion criteria

1. Patients who have taken photosensitizer for photodynamic therapy
2. Patients with cardiac pacemakers
3. Patients who are in poor general status
4. Patients who are pregnancy, suspicion of pregnancy, or lactating
5. Patients who are judged ineligible to enroll into this clinical study due to any reasons by the doctor

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Masakazu
Middle name
Last name Toi

Organization

Graduate School of Medicine, Kyoto University

Division name

Breast Surgery

Zip code

606-8507

Address

54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Japan

TEL

075-751-3660

Email

toi@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name Masahiro
Middle name
Last name Takada

Organization

Kyoto University Hospital

Division name

Breast Surgery

Zip code

606-8507

Address

54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Japan

TEL

075-751-3660

Homepage URL


Email

masahiro@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Graduate School of Medicine, Kyoto University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Canon Inc.

Name of secondary funder(s)

Canon Inc.


IRB Contact (For public release)

Organization

Kyoto University Graduate School and Faculty of Medicine, Ethics Committee

Address

54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Japan

Tel

075-753-4680

Email

ethcom@kuhp.kyoto-u.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2013 Year 11 Month 08 Day


Related information

URL releasing protocol

https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014323

Publication of results

Published


Result

URL related to results and publications

https://www.nature.com/articles/srep41970

Number of participants that the trial has enrolled

30

Results

This clinical study indicated that photoacoustic imaging system appears to be a promising tool for noninvasive analysis of human blood vessels and may contribute to improve cancer diagnosis.

Results date posted

2020 Year 03 Month 18 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2017 Year 02 Month 07 Day

Baseline Characteristics

<Inclusion criteria>
1. Patients who have benign or malignant tumors within the breast
2. Patients whose performance status are 0 or 1
3. Female patients who can agree to participate in this study of their own will, and aged 20 years and older at the time of informed consent
<Exclusion criteria>
1. Patients who have taken photosensitizer for photodynamic therapy
2. Patients with cardiac pacemakers
3. Patients who are in poor general status
4. Patients who are pregnancy, suspicion of pregnancy, or lactating
5. Patients who are judged ineligible to enroll into this clinical study due to any reasons by the doctor

Participant flow

After written informed consent was obtained from all patients, photoacoustic image scan was performed.
They underwent routine radiological (MMG, US, and/or MRI) and/or histological diagnosis (core biopsy) prior to surgery.

Adverse events

none

Outcome measures

Photoacoustic images using wide viewing angle photoacoustic mammography.

Frequency of adverse events of photoacoustic mammography

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2013 Year 11 Month 08 Day

Date of IRB

2014 Year 02 Month 13 Day

Anticipated trial start date

2014 Year 04 Month 01 Day

Last follow-up date

2016 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 11 Month 08 Day

Last modified on

2020 Year 03 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014323


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name