Breast NeoplasmsNCT02529384
Multiple B-value Diffusion-weighted Imaging(DWI) in Evaluation of Breast Lesions
An observational study of Breast Neoplasms and DWI, run by Tang-Du Hospital at 1 site in China.
Trial summary
Breast cancer is the most commonly diagnosed cancer in women and its definite diagnose is still challenge for radiologist. This study is going to evaluate multi-b value diffusion weighted imaging in discrimination of breast benign and malignant lesions and explore the diagnostic effect of the combination of… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Neoplasms, DWI
- What is being tested?
- Breast magnetic resonance scanning
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with brest lesions.
Who may be able to join
- Female patient with breast lesion (Breast Imaging Reporting and Data System 2,3,4,5)
- Operation is take in Tang-du hospital
Who cannot join
- Postoperative patient
- Suffer radiotherapy,chemotherapy and endocrine treatment
- Serious image artifacts
- Lesion with diameter less than 3mm
- Scan during menstrual period
- Other magnetic resonance imaging contraindications
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tang-Du Hospital
Xi’an, Shanxi
Xie Zhuo, MM, 18706798191
About this study
Official title: Multiple B-value Diffusion-weighted Imaging in Evaluation of Breast Lesions：Compare Biexponential Model, Stretched Exponential Model, Conventional Monoexponential DWI and Pathological Specimens.
Breast cancer is the most commonly diagnosed cancer in women and its definite diagnose is still challenge for radiologist. This study is going to evaluate multi-b value diffusion weighted imaging in discrimination of breast benign and malignant lesions and explore the diagnostic effect of the combination of multi-parameter. At the same time, pathological specimens of patients will be collected. The relationship between magnetic resonance(MR) parameters and pathology biomarkers will be evaluated. Hope multi-b value diffusion weighted imaging can improve diagnosis for breast lesion and provide the basis for clinical treatment. The fundamental of pathology on MR signal change will be further expounded.
Read the detailed description
Breast cancer is the most commonly diagnosed cancer in women and its definite diagnose is still challenge for radiologist. This study is going to evaluate multi-b values diffusion weighted imaging in discrimination of breast benign and malignant lesions and explore the diagnostic effect of the combination of multi-parameters. At the same time, pathological specimens of patients will be collected. The relationship between MR parameters and pathology biomarkers will be evaluated. By pre-contrast and post-contrast multi-b values diffusion weighted imaging series, patient's Apparent diffusion coefficient(ADC),tissue diffusivity (D), pseudo-diffusion coefficient (D*), perfusion fraction (f), distributed diffusion coefficient(DDC) and alpha will be evaluated. Parameters of benign , malignant breast lesions and ipsilateral or contralateral normal breast parenchyma as a control group will be measured. Receiver operating characteristic (ROC) curve analysis is used to test the ability of different parameters in differentiating malignant from begin lesions. After Surgical operation, specimen of lesion will be collected(Not every patient's specimen will be collected. The investigators should be approved by patient themselves). The biomarkers of specimen will be detected by pathological and molecular-biological methods.Then analyze the relation between parameters of the MR imaging and pathological/molecular-biological biomarkers.
- Conditions
- Breast Neoplasms, DWI
- Being tested
- Breast magnetic resonance scanning
- Keywords
- Breast magnetic resonance imaging, Diffusion-weighted imaging, Multiple b-value diffusion weighted imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast magnetic resonance scanningOther
Just a muti-b value series in breast MRI
| Study group | Role | What they receive |
|---|---|---|
| malignant group | The lesion which is malignant tumors in breast Receives: Other: Breast magnetic resonance scanning | |
| begin group | The lesion which is begin lesion in breast Receives: Other: Breast magnetic resonance scanning | |
| The control group | Patient's ipsilateral or contralateral normal breast parenchyma were collected as a control group Receives: Other: Breast magnetic resonance scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
The values of Apparent diffusion coefficient (ADC, mm^2/s), tissue diffusivity (D, mm^2/s), pseudo-diffusion coefficient (D*, mm^ 2/s) measured from the DWI image
Parameters of multiple b-value and conventional DWI: ADC (mm^2/s), D (mm^2/s), D* (mm^2/s), distributed diffusion coefficient (DDC, mm^2/s).
Measured: From first week to 92 week
The positive rates of molecular markers from the immunohistochemistry sections
Immunohistochemistry index (immunopositive rate, calculated with the numbers of positively labeled cells [2 fold increase vs the background] divided by the number of total cells) for estrogen receptor (ER), progesterone receptor(PR), Ki-67 (KI-67), Her 2 and Aquaporins.
Measured: From first week to 92 week
The density measurement of microvessel density (MVD) and microlymphatic density (MLD)
MVD: the number of microvessels divided by the observing area; MLD: the number of lymphocytes divided by the observing area.
Measured: From first week to 92 week
Secondary outcomes (3)
Value of intraclass correlation coefficient (ICC) within inter-observe and intra-observe
The intraclass correlation coefficient(ICC) of inter-observe and intra-observe.
Measured: From 92 week to 120 week.
The true-positive and true-negative rates for each parameter
The true-positive, false-positve,true-negative and false negative rates for each paramter are first calculated. Then the diagonistic sensitivity and specificity of each parameter are decided.
Measured: From 92 week to 120 week.
The values of R and P for Pearson Correlation analyses between DWI parameters and molecular/morphological markers
Correlation coefficient of each MR and pathological/molecular-biological biomarkers.
Measured: From 120 week to 130 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study startJan 2015
- Primary completionOct 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bao Ying Chen, M . D ., Study director, Radiology department of Tang-Du hosipital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529384
- Sponsor's protocol ID
- TDLL-2015128
- Status last verified
- Aug 2015
- First submitted
- 16 Jun 2015
- Last updated
- 20 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple B-value Diffusion-weighted Imaging in Evaluation of Breast Lesions：Compare Biexponential Model, Stretched Exponential Model, Conventional Monoexponential DWI and Pathological Specimens.
- ClinicalTrials.gov ID
- NCT02529384
- Acronym / sponsor ID
- TDLL-2015128
- Conditions
- Breast Neoplasms, DWI
- Keywords
- Breast magnetic resonance imaging, Diffusion-weighted imaging, Multiple b-value diffusion weighted imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 20 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breast cancer is the most commonly diagnosed cancer in women and its definite diagnose is still challenge for radiologist. This study is going to evaluate multi-b value diffusion weighted imaging in discrimination of breast benign and malignant lesions and explore the diagnostic effect of the combination of multi-parameter. At the same time, pathological specimens of patients will be collected. The relationship between magnetic resonance(MR) parameters and pathology biomarkers will be evaluated. Hope multi-b value diffusion weighted imaging can improve diagnosis for breast lesion and provide the basis for clinical treatment. The fundamental of pathology on MR signal change will be further expounded.
Detailed description
Breast cancer is the most commonly diagnosed cancer in women and its definite diagnose is still challenge for radiologist. This study is going to evaluate multi-b values diffusion weighted imaging in discrimination of breast benign and malignant lesions and explore the diagnostic effect of the combination of multi-parameters. At the same time, pathological specimens of patients will be collected. The relationship between MR parameters and pathology biomarkers will be evaluated. By pre-contrast and post-contrast multi-b values diffusion weighted imaging series, patient's Apparent diffusion coefficient(ADC),tissue diffusivity (D), pseudo-diffusion coefficient (D*), perfusion fraction (f), distributed diffusion coefficient(DDC) and alpha will be evaluated. Parameters of benign , malignant breast lesions and ipsilateral or contralateral normal breast parenchyma as a control group will be measured. Receiver operating characteristic (ROC) curve analysis is used to test the ability of different parameters in differentiating malignant from begin lesions. After Surgical operation, specimen of lesion will be collected(Not every patient's specimen will be collected. The investigators should be approved by patient themselves). The biomarkers of specimen will be detected by pathological and molecular-biological methods.Then analyze the relation between parameters of the MR imaging and pathological/molecular-biological biomarkers.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| malignant group | – | Other: Breast magnetic resonance scanningThe lesion which is malignant tumors in breast |
| begin group | – | Other: Breast magnetic resonance scanningThe lesion which is begin lesion in breast |
| The control group | – | Other: Breast magnetic resonance scanningPatient's ipsilateral or contralateral normal breast parenchyma were collected as a control group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with brest lesions.
Key inclusion criteria (2 listed)
- Female patient with breast lesion (Breast Imaging Reporting and Data System 2,3,4,5)
- Operation is take in Tang-du hospital
Key exclusion criteria (6 listed)
- Postoperative patient
- Suffer radiotherapy,chemotherapy and endocrine treatment
- Serious image artifacts
- Lesion with diameter less than 3mm
- Scan during menstrual period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast magnetic resonance scanningJust a muti-b value series in breast MRI | Other | The control group, begin group, malignant group |
Primary outcome
The values of Apparent diffusion coefficient (ADC, mm^2/s), tissue diffusivity (D, mm^2/s), pseudo-diffusion coefficient (D*, mm^ 2/s) measured from the DWI image
Time frame: From first week to 92 week
Parameters of multiple b-value and conventional DWI: ADC (mm^2/s), D (mm^2/s), D* (mm^2/s), distributed diffusion coefficient (DDC, mm^2/s).
The positive rates of molecular markers from the immunohistochemistry sections
Time frame: From first week to 92 week
Immunohistochemistry index (immunopositive rate, calculated with the numbers of positively labeled cells [2 fold increase vs the background] divided by the number of total cells) for estrogen receptor (ER), progesterone receptor(PR), Ki-67 (KI-67), Her 2 and Aquaporins.
The density measurement of microvessel density (MVD) and microlymphatic density (MLD)
Time frame: From first week to 92 week
MVD: the number of microvessels divided by the observing area; MLD: the number of lymphocytes divided by the observing area.
3 secondary outcomes
Value of intraclass correlation coefficient (ICC) within inter-observe and intra-observe
Time frame: From 92 week to 120 week.
The true-positive and true-negative rates for each parameter
Time frame: From 92 week to 120 week.
The values of R and P for Pearson Correlation analyses between DWI parameters and molecular/morphological markers
Time frame: From 120 week to 130 week.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2015.
Related trials for Breast Neoplasms
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
Low-Dose Apatinib Plus Chemotherapy in ADC-Pretreated HER2-Positive and HER2-Low Advanced Breast Cancer
Breast Neoplasms, Advanced Breast Cancer
RecruitingPhase 3
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
Breast Neoplasms
Active, not recruitingPhase 2
Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases
Breast Cancer Stage IV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bao Ying Chen, M . D . study director
Radiology department of Tang-Du hosipital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms and DWI, run by Tang-Du Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bao Ying Chen, M . D . (18629527901, chenby128@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The values of Apparent diffusion coefficient (ADC, mm^2/s), tissue diffusivity (D, mm^2/s), pseudo-diffusion coefficient (D*, mm^ 2/s) measured from the DWI image (time frame: From first week to 92 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2015.