UMIN-CTR Clinical Trial

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

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

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

Primary outcomes

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

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

CESM society

Institute

Department

Personal name

Organization

NA

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

01

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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