Breast CancerNCT03592004
Radiomics of Mp-MRI Assessing NAC Outcome in Breast Cancer
An observational study of Breast Cancer and Radiomics, run by Chinese Academy of Sciences at 1 site in China.
Trial summary
This is a single-arm, multicentre study that aims to assess whether Radiomics combining multiparametric MRI and clinical data could be a good predictor of the responses to neoadjuvant chemotherapy in Breast Cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer, Radiomics, Neoadjuvant Chemotherapy
- What is being tested?
- neoadjuvant chemotherapy
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 18 Jul 2018to 1 Jun 2022
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Chinese
Who may be able to join
- biopsy-proven invasive breast cancer;
- received complete neoadjuvant chemotherapy and no treatment has been done before;
- surgery was performed after completion of neoadjuvant chemotherapy, after which pCR was confirmed by postoperative pathological examination;
- pretreatment MRI data within a month before the start of the treatment was eligible, including T2WI, DWI and DCE-MRI.
Who cannot join
- not completing neoadjuvant chemoradiotherapy;
- not undergoing surgery at our hospital, or pCR was not assessed;
- lack of T2WI, or DWI or DCE-MRI data;
- insufficient MRI quality to obtain measurements (e.g., owing to motion artifacts);
- had unilateral multifocal cancers, and the correlation between the tumor in MR images and postoperative pathological examination was uncertain.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhenyu Liu
Beijing, 100190
Zhenyu Liu, Doctor, 8613466358609
About this study
Official title: Radiomics of Multiparametric MRI for Neoadjuvant Chemotherapy Outcomes Assessment in Breast Cancer
This is a single-arm, multicentre study that aims to assess whether Radiomics combining multiparametric MRI and clinical data could be a good predictor of the responses to neoadjuvant chemotherapy in Breast Cancer.
Read the detailed description
Patients undergo multiparametric MRI (including T2WI, DWI and DCE-MRI) at baseline, after 2 courses of neoadjuvant chemotherapy, and prior to the surgery at least 8 weeks after the treatment procedure. Patients undergo biopsy test in one week after the baseline MRI scan to detect the biomarkers including ER, PR, Her-2 and Ki-67, which can be used to select the treatment plan referring to the NCCN clinical guidelines. After the surgery, responses to neoadjuvant chemotherapy are determined according to the histopathologically examination of the surgically resected specimens.
After completion of treatment procedure, patients are followed up for 5 years.
- Being tested
- neoadjuvant chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoadjuvant chemotherapyOther
neoadjuvant chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Guangdong General Hospital | Not described Receives: Other: neoadjuvant chemotherapy | |
| Cancer Hospital Chinese Academy Of Medical Sciences | Not described Receives: Other: neoadjuvant chemotherapy | |
| Beijing Friendship Hospital | Not described Receives: Other: neoadjuvant chemotherapy | |
| Yunnan Cancer Hospital | Not described Receives: Other: neoadjuvant chemotherapy | |
| Liaoning Cancer Hospital | Not described Receives: Other: neoadjuvant chemotherapy | |
| The First Hospital Of China Medical University | Not described Receives: Other: neoadjuvant chemotherapy | |
| Affiliated Hospital Of Hebei University | Not described Receives: Other: neoadjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
predicting pathological complete response (pCR) or no response (NR)
The value of Radiomics of multiparametric MRI in predicting responses to neoadjuvant chemotherapy, including pathological complete response (pCR) and no response (NR).
Measured: 20 weeks
5 years for Disease free survival
The association between Radiomics of multiparametric MRI and disease free survival (DFS), which defined as the time from the beginning of neoadjuvant chemotherapy to the confirmed time of recurrence or metastatic disease, or death due to any other cause.
Measured: 5 years
5 years for Overall survival
The association between Radiomics of multiparametric MRI and overall survival (OS), which defined as the time from the beginning of neoadjuvant chemotherapy to the death with any causes.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start18 Jul 2018 (estimated)
- Primary completion1 Jun 2019 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Sciences
- Sponsor type
- Other government
- Collaborators
- Guangdong Provincial People's Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing Friendship Hospital, Yunnan Cancer Hospital, Liaoning Cancer Hospital & Institute, First Hospital of China Medical University, Affiliated Hospital of Hebei University
- Responsible party
- Principal investigator, Zhenyu Liu, Chinese Academy of Sciences
- Investigators
- Jie Tian, Doctor, Principal investigator, Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592004
- Sponsor's protocol ID
- ZLiu
- Status last verified
- Jul 2018
- First submitted
- 26 Jun 2018
- Last updated
- 19 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiomics of Multiparametric MRI for Neoadjuvant Chemotherapy Outcomes Assessment in Breast Cancer
- ClinicalTrials.gov ID
- NCT03592004
- Acronym / sponsor ID
- ZLiu
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Chinese Academy of SciencesOther government
- Collaborators
- Guangdong Provincial People's Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing Friendship Hospital, Yunnan Cancer Hospital, Liaoning Cancer Hospital & Institute, First Hospital of China Medical University, Affiliated Hospital of Hebei University
- Study start
- 18 Jul 2018 (estimated)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 19 Jul 2018 (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 is a single-arm, multicentre study that aims to assess whether Radiomics combining multiparametric MRI and clinical data could be a good predictor of the responses to neoadjuvant chemotherapy in Breast Cancer.
Detailed description
Patients undergo multiparametric MRI (including T2WI, DWI and DCE-MRI) at baseline, after 2 courses of neoadjuvant chemotherapy, and prior to the surgery at least 8 weeks after the treatment procedure. Patients undergo biopsy test in one week after the baseline MRI scan to detect the biomarkers including ER, PR, Her-2 and Ki-67, which can be used to select the treatment plan referring to the NCCN clinical guidelines. After the surgery, responses to neoadjuvant chemotherapy are determined according to the histopathologically examination of the surgically resected specimens.
After completion of treatment procedure, patients are followed up for 5 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Guangdong General Hospital | – | Other: neoadjuvant chemotherapy |
| Cancer Hospital Chinese Academy Of Medical Sciences | – | Other: neoadjuvant chemotherapy |
| Beijing Friendship Hospital | – | Other: neoadjuvant chemotherapy |
| Yunnan Cancer Hospital | – | Other: neoadjuvant chemotherapy |
| Liaoning Cancer Hospital | – | Other: neoadjuvant chemotherapy |
| The First Hospital Of China Medical University | – | Other: neoadjuvant chemotherapy |
| Affiliated Hospital Of Hebei University | – | Other: neoadjuvant chemotherapy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Chinese
Key inclusion criteria (4 listed)
- biopsy-proven invasive breast cancer;
- received complete neoadjuvant chemotherapy and no treatment has been done before;
- surgery was performed after completion of neoadjuvant chemotherapy, after which pCR was confirmed by postoperative pathological examination;
- pretreatment MRI data within a month before the start of the treatment was eligible, including T2WI, DWI and DCE-MRI.
Key exclusion criteria (5 listed)
- not completing neoadjuvant chemoradiotherapy;
- not undergoing surgery at our hospital, or pCR was not assessed;
- lack of T2WI, or DWI or DCE-MRI data;
- insufficient MRI quality to obtain measurements (e.g., owing to motion artifacts);
- had unilateral multifocal cancers, and the correlation between the tumor in MR images and postoperative pathological examination was uncertain.
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 |
|---|---|---|
| neoadjuvant chemotherapyneoadjuvant chemotherapy | Other | Affiliated Hospital Of Hebei University, Beijing Friendship Hospital, Cancer Hospital Chinese Academy Of Medical Sciences, Guangdong General Hospital, Liaoning Cancer Hospital, The First Hospital Of China Medical University, Yunnan Cancer Hospital |
Primary outcome
predicting pathological complete response (pCR) or no response (NR)
Time frame: 20 weeks
The value of Radiomics of multiparametric MRI in predicting responses to neoadjuvant chemotherapy, including pathological complete response (pCR) and no response (NR).
5 years for Disease free survival
Time frame: 5 years
The association between Radiomics of multiparametric MRI and disease free survival (DFS), which defined as the time from the beginning of neoadjuvant chemotherapy to the confirmed time of recurrence or metastatic disease, or death due to any other cause.
5 years for Overall survival
Time frame: 5 years
The association between Radiomics of multiparametric MRI and overall survival (OS), which defined as the time from the beginning of neoadjuvant chemotherapy to the death with any causes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Jie Tian, Doctor principal investigator
Chinese Academy of Sciences
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 Cancer and Radiomics, run by Chinese Academy of Sciences 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 4 inclusion and 5 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 19 Jul 2018. 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 Zhenyu Liu, Doctor (8613466358609, zhenyu.liu@ia.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
predicting pathological complete response (pCR) or no response (NR) (time frame: 20 weeks). 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 19 Jul 2018.