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 | 2024/12/20 15:52:28 |
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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
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
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
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
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
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
Completed
Date of protocol fixation
| 2011 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2014 | Year | 01 | Month | 08 | Day |
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Recruitment is now closed.
Management information
Registered date
| 2013 | Year | 09 | Month | 27 | Day |
Last modified on
| 2024 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007654
