UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011888
Receipt number R000007654
Scientific Title Clinical study of in vivo optic imaging of breast cancer using diffuse optic spectroscopy
Date of disclosure of the study information 2013/09/29
Last modified on 2015/08/20 11:43:42

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Basic information

Public title

Clinical study of in vivo optic imaging of breast cancer using diffuse optic spectroscopy

Acronym

Breast cancer imaging using diffuse optic spectroscopy

Scientific Title

Clinical study of in vivo optic imaging of breast cancer using diffuse optic spectroscopy

Scientific Title:Acronym

Breast cancer imaging using diffuse optic spectroscopy

Region

Japan


Condition

Condition

Breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate usefulness of diffuse optic spectroscopy in order to detect early-stage breast cancer and to monitor treatment response for tumors during chemotherapy. Saitama medical university and Hamamatsu medical university conducted the collaborative study. Recently, we established time-resolved (TR)-DOSI system (TRS10/TRS20, Hamamatsu Inc., Hamamatsu, Japan) for breast measurement and reported that elevated lesion total hemoglobin (tHb) concentration which contrasted by background normal tissue tHb concentration significantly correlated with cancer cell mitotic index and glucose accumulation of tumor measured by FDG-PET/CT, and then concluded the association could reflect metabolic coupling to angiogenesis. The aim of this prospective study was to evaluate diagnostic performance of sequential scans using TR-DOSI for monitoring early chemotherapy response. The primary objective was to determine whether changes in lesion tHb concentration measured after the 1st and 2nd courses of cytotoxic drugs could predict a pCR in patients with primary breast cancer. The secondary objective was to compare the diagnostic performance of TR-DOSI and FDG-PET/CT for predicting a pCR.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II


Assessment

Primary outcomes

(1)Rate of detection of early-stage breast cancer
(2)Rate of clinicopathologic response (pCR) in the setting of neoadjuvant chemotherapy

Key secondary outcomes

(3)Disease-free survival
(4)Overall survival


Base

Study type


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

To measure optical parameters of breast cancer using optical device as well as conventional imaging devices on treatment.
The aim of this prospective study was to evaluate diagnostic performance of sequential scans using TR-DOSI for monitoring early chemotherapy response. The primary objective was to determine whether changes in lesion tHb concentration measured after the 1st and 2nd courses of cytotoxic drugs could predict a pCR in patients with primary breast cancer. The secondary objective was to compare the diagnostic performance of TR-DOSI and FDG-PET/CT for predicting a pCR.

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

18 years-old <=

Age-upper limit

100 years-old >

Gender

Male and Female

Key inclusion criteria

Patients aged older than 18 years who had 1) newly diagnosed biopsy-proven breast cancer, 2) had clinical stage T1c-4, N0-2 primary breast cancer according to TNM classification 6th edition, 3) planned to undergo at least 4 cycles of chemotherapy were eligible for a prospective TR-DOSI chemotherapy monitoring study.

Key exclusion criteria

Exclusion criteria were the following; pregnancy, prior treatment of breast cancer, bilateral breast cancer, or ineligibility of surgery.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shigeto UEDA

Organization

International medical center, saitama medical university

Division name

Department of breast oncology

Zip code


Address

1397-1 Yamane, Hidaka, Saitama, Japan

TEL

81-42-984-4670

Email

syueda@saitma-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shigeto UEDA

Organization

International medical center, saitama medical university

Division name

Department of breast oncology

Zip code


Address

1397-1 Yamane, Hidaka, Saitama, Japan

TEL

81-42-984-4670

Homepage URL


Email

syueda@saitma-med.ac.jp


Sponsor or person

Institute

Department of breast oncology, international medical center, saitama medical university

Institute

Department

Personal name



Funding Source

Organization

Department of breast oncology, international medical center, saitama medical university

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Hamamatsu University, Medical school

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

埼玉医大国際医療センター(埼玉県)、浜松医科大学(静岡県)


Other administrative information

Date of disclosure of the study information

2013 Year 09 Month 29 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Trial entry of patients who were eligible for this study was completed. Dana analysis is underway.

Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2011 Year 08 Month 26 Day

Date of IRB


Anticipated trial start date

2011 Year 12 Month 01 Day

Last follow-up date


Date of closure to data entry

2015 Year 08 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 09 Month 27 Day

Last modified on

2015 Year 08 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007654


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name