Breast Carcinoma; Magnetic Resonance Imaging; Diffusion Spectrum ImagingNCT05159323
Quantitative Assessment of Diffusion Spectrum Imaging in Breast Cancer
A study testing Diffusion Spectrum Imaging in people with Breast Carcinoma; Magnetic Resonance Imaging; Diffusion Spectrum Imaging, run by Xiang Zhang at 1 site in China.
Trial summary
This project intends to prospectively collect patients with suspected breast malignant tumors by ultrasound or mammography. After routine MRI scanning, all patients underwent diffusion spectrum imaging (DSI) sequence scanning. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Carcinoma; Magnetic Resonance Imaging; Diffusion Spectrum Imaging
- What is being tested?
- Diffusion Spectrum Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2021to 19 Aug 2022
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer was confirmed by surgery or biopsy.
- Pathologically diagnosis of estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor 2 (HER-2), Ki-67, and lymphatic vessel invasion (LVI) status in breast cancer.
- Routine MRI and DSI scans were performed within one week before the pathologic examination.
Who cannot join
- Patients who had received treatment before DSI scanning.
- Patients who underwent breast tumor biopsy within two weeks before DSI image acquisition.
- Pathology results of breast masses were other diseases besides breast cancer.
- Post-processing of DSI data cannot be performed due to poor image quality, such as motion artifacts.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Radiology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510120
Jun Shen, M.D., +86-20-81338253, shenjun@mail.sysu.edu.cn
About this study
Official title: Quantitative Parameters of Diffusion Spectrum Imaging: Correlation With Histopathologic Characteristics in Patients With Breast Cancer
This project intends to prospectively collect patients with suspected breast malignant tumors by ultrasound or mammography. After routine MRI scanning, all patients underwent diffusion spectrum imaging (DSI) sequence scanning. The inclusion criteria were as follows: (1) breast cancer was confirmed by surgery or biopsy. (2) pathologically diagnosis of estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor 2 (HER-2), Ki-67, and lymphatic vessel invasion (LVI) status in breast cancer. (3) routine MRI and DSI scans were performed within one week before the pathologic examination. The exclusion criteria were as follows: (1) patients who had received treatment before DSI scanning; (2) patients who underwent breast tumor biopsy within two weeks before DSI image acquisition; (3) pathology results of breast masses were other diseases besides breast cancer. (4) post-processing of DSI data cannot be performed due to poor image quality, such as motion artifacts.
Breast MRI data were collected on a 3T MR scanner (Magnetom skyra, Siemens Healthcare, Erlangen, Germany). All participants used standardized breast MRI scanning schemes, including T2 weighted imaging (T2WI), T1 weighted imaging (T1WI), diffusion-weighted imaging (DWI), DSI, and contrast dynamic enhancement (DCE). A total of 22 GSI quantitative parameters were derived from NeudiLab software that is based on the open-source platform DIPY (diffusion imaging in Python, http://nipy.org/dipy). The correlation between DSI quantitative parameters and pathological indexes (i.e., ER, PR, HER-2, Ki-67, and LVI) was evaluated by Spearman correlation analysis. The independent predictors of GSI quantitative parameters for different pathologic characteristics discrimination in breast cancer were determined by the logistic regression analysis. The predictive performance of DSI quantitative parameters for difference pathologic classifications was assessed by the receiver operating characteristic (ROC) curves and their respective area under the curves (AUCs).
- Being tested
- Diffusion Spectrum 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.
Diffusion Spectrum ImagingDiagnostic test
A novel diffusion-based magnetic resonance imaging method
| Study group | Role | What they receive |
|---|---|---|
| Diffusion Spectrum Imaging | Experimental | All participants accept diffusion spectrum imaging, the quantitative parameters of the diffusion spectrum imaging are obtained. The quantitative parameters are compared in different subgroups based on the pathologic examination results. Receives: Diagnostic Test: Diffusion Spectrum Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic characteristic
Estrogen receptor (ER) status of breast cancer
Measured: Up to 2 months
Secondary outcomes (1)
Pathologic characteristic
Progesterone receptor (PR) status of breast cancer
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start20 Aug 2021
- Primary completion19 Aug 2022 (estimated)
- Study completion19 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Carcinoma; Magnetic Resonance Imaging; Diffusion Spectrum ImagingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiang Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiang Zhang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Xiang Zhang, M.D., Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05159323
- Sponsor's protocol ID
- SYSEC-KY-KS-2021-182
- Status last verified
- Dec 2021
- First submitted
- 21 Nov 2021
- Last updated
- 16 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang X, Qiu Y, Jiang W, Yang Z, Wang M, Li Q, Liu Y, Yan X, Yang G, Shen J. Mean Apparent Propagator MRI: Quantitative Assessment of Tumor-Stroma Ratio in Invasive Ductal Breast Carcinoma. Radiol Imaging Cancer. 2024 Jul;6(4):e230165. doi: 10.1148/rycan.230165.
PubMed 38874529
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Parameters of Diffusion Spectrum Imaging: Correlation With Histopathologic Characteristics in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT05159323
- Acronym / sponsor ID
- SYSEC-KY-KS-2021-182
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Xiang ZhangUniversity, hospital or other
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 19 Aug 2022 (estimated)
- Study completion
- 19 Aug 2022 (estimated)
- First posted
- 16 Dec 2021 (actual)
- 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.
This project intends to prospectively collect patients with suspected breast malignant tumors by ultrasound or mammography. After routine MRI scanning, all patients underwent diffusion spectrum imaging (DSI) sequence scanning. The inclusion criteria were as follows: (1) breast cancer was confirmed by surgery or biopsy. (2) pathologically diagnosis of estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor 2 (HER-2), Ki-67, and lymphatic vessel invasion (LVI) status in breast cancer. (3) routine MRI and DSI scans were performed within one week before the pathologic examination. The exclusion criteria were as follows: (1) patients who had received treatment before DSI scanning; (2) patients who underwent breast tumor biopsy within two weeks before DSI image acquisition; (3) pathology results of breast masses were other diseases besides breast cancer. (4) post-processing of DSI data cannot be performed due to poor image quality, such as motion artifacts.
Breast MRI data were collected on a 3T MR scanner (Magnetom skyra, Siemens Healthcare, Erlangen, Germany). All participants used standardized breast MRI scanning schemes, including T2 weighted imaging (T2WI), T1 weighted imaging (T1WI), diffusion-weighted imaging (DWI), DSI, and contrast dynamic enhancement (DCE). A total of 22 GSI quantitative parameters were derived from NeudiLab software that is based on the open-source platform DIPY (diffusion imaging in Python, http://nipy.org/dipy). The correlation between DSI quantitative parameters and pathological indexes (i.e., ER, PR, HER-2, Ki-67, and LVI) was evaluated by Spearman correlation analysis. The independent predictors of GSI quantitative parameters for different pathologic characteristics discrimination in breast cancer were determined by the logistic regression analysis. The predictive performance of DSI quantitative parameters for difference pathologic classifications was assessed by the receiver operating characteristic (ROC) curves and their respective area under the curves (AUCs).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diffusion Spectrum Imaging | Experimental | Diagnostic Test: Diffusion Spectrum ImagingAll participants accept diffusion spectrum imaging, the quantitative parameters of the diffusion spectrum imaging are obtained. The quantitative parameters are compared in different subgroups based on the pathologic examination results. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Breast cancer was confirmed by surgery or biopsy.
- Pathologically diagnosis of estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor 2 (HER-2), Ki-67, and lymphatic vessel invasion (LVI) status in breast cancer.
- Routine MRI and DSI scans were performed within one week before the pathologic examination.
Key exclusion criteria (4 listed)
- Patients who had received treatment before DSI scanning.
- Patients who underwent breast tumor biopsy within two weeks before DSI image acquisition.
- Pathology results of breast masses were other diseases besides breast cancer.
- Post-processing of DSI data cannot be performed due to poor image quality, such as motion artifacts.
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 |
|---|---|---|
| Diffusion Spectrum ImagingA novel diffusion-based magnetic resonance imaging method | Diagnostic test | Diffusion Spectrum Imaging |
Primary outcome
Pathologic characteristic
Time frame: Up to 2 months
Estrogen receptor (ER) status of breast cancer
1 secondary outcome
Pathologic characteristic
Time frame: Up to 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- Derived from this study: PubMed 38874529Zhang X, Qiu Y, Jiang W, Yang Z, Wang M, Li Q, Liu Y, Yan X, Yang G, Shen J. Mean Apparent Propagator MRI: Quantitative Assessment of Tumor-Stroma Ratio in Invasive Ductal Breast Carcinoma. Radiol Imaging Cancer. 2024 Jul;6(4):e230165. doi: 10.1148/rycan.230165.
- Individual participant dataSharing planned: No
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.
Xiang Zhang, M.D. principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diffusion Spectrum Imaging in people with Breast Carcinoma; Magnetic Resonance Imaging; Diffusion Spectrum Imaging, run by Xiang Zhang 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 3 inclusion and 4 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 16 Dec 2021. 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 Li Ling, Ph.D. (+86-20-81336505, sys_iit@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic characteristic (time frame: Up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05159323, which also lists 1 linked publication.
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 16 Dec 2021.