UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004912
Receipt number R000005849
Scientific Title Comparison of the diagnostic accuracy of Contrast Enhanced Spectral Mammography (CESM) and conventional imaging of Breast Carcinoma.
Date of disclosure of the study information 2011/01/22
Last modified on 2011/01/20 14:38:16

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Basic information

Public title

Comparison of the diagnostic accuracy of Contrast Enhanced Spectral Mammography (CESM) and conventional imaging of Breast Carcinoma.

Acronym

Evaluation of Contrast Enhanced Spectral Mammography

Scientific Title

Comparison of the diagnostic accuracy of Contrast Enhanced Spectral Mammography (CESM) and conventional imaging of Breast Carcinoma.

Scientific Title:Acronym

Evaluation of Contrast Enhanced Spectral Mammography

Region

Japan


Condition

Condition

Participants in this study will be adult female who fulfills the following four criteria:
1. Examined by mammography or ultrasound this past year, and was diagnosed as ACR category 3.
2. Diagnosed as CESM applicant by research investigator or sub investigator, having interview, clinical breast examination, and other examinations.
3. Adult female over 20 years old
4. Signed a consent form to participate this clinical study

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

These women had lesions that were initially depicted at plain mammography (PM) or ultrasound (US) and that were suspected of being malignant . The patients are separated into two categories.
Group A: Depicted at US
Group B: only by PM. The purpose study is to investigate the following:
1. To investigate the potential of CESM and compare with PM for A) Category
1.1 Sensitivity
Sensitivity CESM vs. PM
1.2 Characterization
Classified as BI-RADS categories defined by ACR both for PM, CESM images. Then make a definitive diagnosis by Pathology assessment. Finally evaluate the efficiency for CESM by ROC.
2. To investigate the potential of CESM compare with PM for B) Category
2.1 Sensitivity
Equivalence trial PM and CESM
2.2 Characterization
Evaluate the accuracy for CESM by ROC.
3. Confirm the adverse event for CESM

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1.Primary Endpoint
Evaluate the sensitivity of CESM
2. Secondary endpoint
Evaluate characteristics and adverse events of CESM

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine Device,equipment

Interventions/Control_1

30 cases for both group A
Duration of study:
January 2011 to June 30
Contrast agent:
Nonionic solution containing
350 mg of iodine per milliliter
X-ray: radiology exposure less than 0.2mSv

Interventions/Control_2

30 cases for both group B
Duration of study:
January 2011 to June 30
Contrast agent:
Nonionic solution containing
350 mg of iodine per milliliter
X-ray: radiology exposure less than 0.2mSv

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

Objective of participant selection is to satisfy following selection criteria and not conflict with exclusion criteria.

Criteria for selecting participants: Adult female who visit research laboratories to be diagnosed breast cancer
using diagnostic imaging, and fulfill following criteria;
1.Conducted PM and/or US this past year and diagnosed as ACR category 3
2.Diagnosed as CESM applicant by research investigator or sub investigator's interview, clinical breast examination, and other examinations.
3.Adult female over 20 years old.
Signed a consent form to participate this clinical study

Key exclusion criteria

Exclude patients who meet the following criteria
1 Complications and/or preexisting disorders of respiratory disease, such as asthma,chronic obstructive pulmonary disease, pulmonary cancer, and interstitial pneumonia.
2 Preexisting disorders of being allergic to iodinated contrast material and iodine-containing drug medicine, complications and/or preexisiting disorders of allergists, such as drug allegy and alimentary allergy.
3 Complications and/or preexisting disorders of the thyroid gland
4 Diabetes drug (metformin) and is not able to take sufficient drug holidays brfore and affer the study (Over 48 hours for bot before and after the study)

5 Patient whose general condition is significantly disordered or has complocations and/or preexisiting disorders of critical cerebropathy, such as hematencephalon and stroke, liver disease, such as hepatic cirrhosis and hpatic failure, kidney disease, such as glomerulonephritis and patient who requiring dialysis.

6 Complications of acute pancreatitis, Waldenstorm's macroglobulinemia multiple myeloma, tetany, and pheochromocytoma.

7 Patinet who performed breast enlargement sturgery including saline-filled and silicone-gel-filled implants.
8 Patient who is diagnosed as mental disorders including moderate or severe dementia and identified by attending physician that she neither fully comprehend nor cooperate.
9 Pregnant women or breast-feeding women.
10.Who is participating or has participanter clinical research study and/or past marketing surveillance for last three months period.
11 Others;attending physician has cancers for a patient to join this clinical study and/or for a patient to be a hinder of evaluation the result.

Reasons of creating exclusion criteria are as follows
1,2,3,4,5,6; contraindicated disease of iodinated contrast materials
7;affecting the risk for interpretation of radiogram
8,9,10,11;general considerations of clinical study

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mitsuhiro Mizutani

Organization

Mikawa Breast cancer clinic

Division name

Breast surgeon, director

Zip code


Address

39-6,hida,shinome-cho,anjyou-shi,Aichi-ken

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

CESM society

Division name

secretariat

Zip code


Address

39-6,hida,shinome-cho,anjyo-shi,Aichi-ken

TEL

+81-566-77-5211

Homepage URL


Email



Sponsor or person

Institute

CESM society

Institute

Department

Personal name



Funding Source

Organization

NA

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


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



Other administrative information

Date of disclosure of the study information

2011 Year 01 Month 22 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


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 01 Month 20 Day

Date of IRB


Anticipated trial start date

2011 Year 01 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 01 Month 20 Day

Last modified on

2011 Year 01 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005849


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name