UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012023 |
|---|---|
| Receipt number | R000014047 |
| Scientific Title | Influence of menstrual cycle and aging on breast MR imaging |
| Date of disclosure of the study information | 2013/10/11 |
| Last modified on | 2023/04/19 17:37:39 |
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Basic information
Public title
Influence of menstrual cycle and aging on breast MR imaging
Acronym
Influence of menstrual cycle and aging on breast MR imaging
Scientific Title
Influence of menstrual cycle and aging on breast MR imaging
Scientific Title:Acronym
Influence of menstrual cycle and aging on breast MR imaging
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between background parenchymal enhancement (BPE) and menstrual cycle/ age on breast MRI in Japanese women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between background parenchymal enhancement (BPE) and menstrual cycle/ age.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 70 | years-old | > |
Gender
Female
Key inclusion criteria
Women scheduled to undergo contrast-enhanced dynamic MRI of breasts.
Key exclusion criteria
Patients with known hypersensitivity to the gadolinium-based contrast agents.
Patients with the past history of breast cancer
Patients who are under drug therapy for breast cancer.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Honda |
Organization
Kyusyu University
Division name
Department of Clinical Radiology
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Hukuoka ,812-8582, JAPAN
TEL
092-642-5695
honda@radiol.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Hidetake |
| Middle name | |
| Last name | Yabuuchi |
Organization
Kyusyu University
Division name
Department of Health Sciences
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Hukuoka ,812-8582, JAPAN
TEL
092-642-6727
Homepage URL
h-yabu@med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyusyu University
Institute
Department
Personal name
Funding Source
Organization
Bayer Yakuhin
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NA
Address
NA
Tel
NA
NA
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 | 10 | Month | 11 | Day |
Related information
URL releasing protocol
10.1016/j.ejrad.2018.11.025
Publication of results
Published
Result
URL related to results and publications
10.1016/j.ejrad.2018.11.025
Number of participants that the trial has enrolled
962
Results
The average C/B ratio was 20.1, 15.7, and 9.1 at the menstrual, proliferative, and secretory phases (p < 0.001). BPE was determined as moderate or marked in 0% and 5.4% at the menstrual phase, 10.3% and 11.0% at the proliferative phase, and 17.5% and 21.7% at the secretory phase by the two observers, respectively
(p = 0.01, p = 0.01).
The menstrual phase and the proliferative phase seem to be suitable for breast MRI of Asian women.
Results date posted
| 2023 | Year | 04 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We conducted a multicenter prospective study involving 24 hospitals in Japan. The study was approved by the Ethical Review Board on Clinical Studies at each institution. Written informed consent for participation was obtained from all patients. The inclusion criteria were as follows:1, female patients who underwent dynamic contrast-enhanced breast MRI for a close examination; 2, age 20-69 years; 3, the patients' menstrual cycle information was obtained by interview.
Participant flow
Written informed consent for participation was obtained from all patients. The inclusion criteria were as follows:1, female patients who underwent dynamic contrast-enhanced breast MRI for a close examination; 2, age 20-69 years; 3, the patient's menstrual cycle information was obtained by interview.
Adverse events
No
Outcome measures
Evaluation 1: BPE of breast tissue on the unaffected side
For a quantitative assessment, a region of interest (ROI) was set manually to include all of the fibroglandular breast tissue on the unaffected side.
Evaluation 2: cancer detectability
For the quantitative assessment, we measured the SIs of fibroglandular breast tissue on the affected side on a pre-contrast image and an early-phase image (SI4), and the SIs of breast cancer on a pre-contrast image (SI5) and those on an early-phase image. We then calculated the cancer/background enhancement (C/B) ratio for each patient.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 06 | Month | 16 | Day |
Date of IRB
| 2013 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2015 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Patients are registered non-selectively.
Patient background and MR imaging information are recorded, and statistical analysis of the data is carried out.
Management information
Registered date
| 2013 | Year | 10 | Month | 11 | Day |
Last modified on
| 2023 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014047
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