Metastatic Breast Cancer in the LiverDreaminLMBCNCT05550090
Dynamic Contrast-enhanced MRI Combined With IVIM-DWI for Early Prediction of Chemosensitivity in Liver MBC
An observational study of Metastatic Breast Cancer in the Liver, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
The purpose of this study is to further use DCE-MRI and ivim-dwi to predict the chemotherapy sensitivity of liver metastasis of breast cancer at an early stage, and to predict the treatment response of tumor at an early stage by using the changes of their functional parameters, and to compare the efficacy and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer in the Liver
- What is being tested?
- Chemotherapy
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 16 Sep 2022to 30 Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with liver metastasis from breast cancer requiring at least 2 cycles of systemic chemotherapy
Who may be able to join
- The primary lesion was pathologically confirmed to be breast cancer, and the patients diagnosed by two imaging methods or pathologically confirmed to be liver metastasis of breast cancer had at least one liver metastasis with the longest diameter ≥ 10mm;
- No second primary malignant tumor;
- ECOG score, 0-2 ;
- The organ function is normal and can tolerate chemotherapy and other anti-tumor treatments;
- The patient plans to receive systemic chemotherapy or systemic anti-tumor treatment, and the whole process of cooperative treatment. The patient has good compliance with the planned treatment and follow-up, can understand the research process of this study and sign a written informed consent；
- Contraception during the study period and within 6 months after treatment, non lactation period.
Who cannot join
- For patients contraindicated to MR examination, such as built-in metal instruments and allergy to contrast agents;
- The patient had diffuse liver metastasis or the number of liver metastatic tumors was more than 5;
- Patients who cannot complete 2 cycles of chemotherapy or systemic anti-tumor treatment;
- Unable to cooperate with follow-up；
- Patients who are not suitable for the study according to the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Ping Huang, +86-13685766632, zlyyhp@163.com
Ping Huang
About this study
Official title: Clinical Study of Dynamic Contrast-enhanced Magnetic Resonance Imaging Combined With IVIM-DWI for Early Prediction of Chemosensitivity in Liver Metastasis of Breast Cance
The purpose of this study is to further use DCE-MRI and ivim-dwi to predict the chemotherapy sensitivity of liver metastasis of breast cancer at an early stage, and to predict the treatment response of tumor at an early stage by using the changes of their functional parameters, and to compare the efficacy and advantages of IVIM functional parameters and DCE-MRI parameters in predicting the efficacy.To explore the efficacy of "perfusion" and "diffusion" parameters of magnetic resonance imaging as "biomarkers" for early prediction of chemotherapy response and prognosis of breast cancer patients with liver metastasis. And to provide guidance for optimizing the clinical treatment scheme of breast cancer patients with liver metastasis.
At the same time, this study will use the method of artificial intelligence to deeply mine the images, and further find out the indicators for early prediction of the therapeutic effect of liver metastasis of breast cancer.
Read the detailed description
The first MR examination was arranged within 7 days before treatment (baseline). The MRI scanning sequence included conventional T1, T2 weighted imaging, T1+dynamic contrast enhanced imaging, and IVIM-DWI imaging.The second and third MR examinations were arranged within 7 days after the first chemotherapy and the second chemotherapy. The examination steps and parameters were the same as those of the first examination.
- Conditions
- Metastatic Breast Cancer in the Liver
- Being tested
- Chemotherapy
- Keywords
- Liver metastasis, Breast cancer, Efficacy prediction
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
Also called Chemotherapy can be combined with targeted or immunotherapy or endocrine therapy.
All patients were given 2 cycles of chemotherapy, including the chemotherapy recommended by the clinical treatment guidelines for advanced metastatic breast cancer, which can be combined with targeted or immune or endocrine therapy.
| Study group | Role | What they receive |
|---|---|---|
| Patients with liver metastasis from breast cancer requiring antitumor therapy | Patients with liver metastasis from breast cancer requiring antitumor therapy Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between DCE-MRI parameters combined with IVIM parameters and short-term efficacy of chemotherapy in patients with liver metastasis of breast cancer
Correlation between DCE-MRI parameters (Ktrans, Ve, Kep) combined with IVIM parameters (D*, D, f) and short-term efficacy of chemotherapy in patients with liver metastasis of breast cancer
Measured: September 2025
Correlation between DCE-MRI parameters combined with IVIM parameters and long-term efficacy of chemotherapy in patients with liver metastasis of breast cancer
Correlation between DCE-MRI parameters (Ktrans, Ve, Kep) combined with IVIM parameters (D*, D, f) and long-term efficacy of chemotherapy in patients with liver metastasis of breast cancer
Measured: September 2025
Secondary outcomes (2)
The consistency of DCE-MRI parameters and IVIM parameters between different observers and the same observer.
The consistency of DCE-MRI parameters and IVIM parameters between different observers and the same observer.
Measured: September 2025
Using artificial intelligence method to deeply mine images, find out new indicators to predict the curative effect of liver metastasis treatment of breast cancer in early stage.
Using artificial intelligence method to deeply mine images, find out new indicators to predict the curative effect of liver metastasis treatment of breast cancer in early stage.
Measured: September 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start16 Sep 2022 (estimated)
- Primary completion16 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast Cancer in the LiverStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huang Ping, Zhejiang Cancer Hospital
- Investigators
- Ping Huang, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05550090
- Sponsor's protocol ID
- ZCHBC022
- Acronym
- DreaminLMBC
- Status last verified
- Sep 2022
- First submitted
- 18 Sep 2022
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Decide whether to share individual participant data after clinical research reaches a certain stage
Publications
Ruiz A, Sebagh M, Wicherts DA, Castro-Benitez C, van Hillegersberg R, Paule B, Castaing D, Vibert E, Cunha AS, Cherqui D, Morere JF, Adam R. Long-term survival and cure model following liver resection for breast cancer metastases. Breast Cancer Res Treat. 2018 Jul;170(1):89-100. doi: 10.1007/s10549-018-4714-1. Epub 2018 Feb 20.
PubMed 29464535Holm J, Li J, Darabi H, Eklund M, Eriksson M, Humphreys K, Hall P, Czene K. Associations of Breast Cancer Risk Prediction Tools With Tumor Characteristics and Metastasis. J Clin Oncol. 2016 Jan 20;34(3):251-8. doi: 10.1200/JCO.2015.63.0624. Epub 2015 Nov 30.
PubMed 26628467Kennecke H, Yerushalmi R, Woods R, Cheang MC, Voduc D, Speers CH, Nielsen TO, Gelmon K. Metastatic behavior of breast cancer subtypes. J Clin Oncol. 2010 Jul 10;28(20):3271-7. doi: 10.1200/JCO.2009.25.9820. Epub 2010 May 24.
PubMed 20498394Golse N, Adam R. Liver Metastases From Breast Cancer: What Role for Surgery? Indications and Results. Clin Breast Cancer. 2017 Jul;17(4):256-265. doi: 10.1016/j.clbc.2016.12.012. Epub 2017 Jan 9.
PubMed 28196771Varoquaux A, Rager O, Lovblad KO, Masterson K, Dulguerov P, Ratib O, Becker CD, Becker M. Functional imaging of head and neck squamous cell carcinoma with diffusion-weighted MRI and FDG PET/CT: quantitative analysis of ADC and SUV. Eur J Nucl Med Mol Imaging. 2013 Jun;40(6):842-52. doi: 10.1007/s00259-013-2351-9. Epub 2013 Feb 22.
PubMed 23436068Koh DM, Collins DJ. Diffusion-weighted MRI in the body: applications and challenges in oncology. AJR Am J Roentgenol. 2007 Jun;188(6):1622-35. doi: 10.2214/AJR.06.1403.
PubMed 17515386Pieper CC, Willinek WA, Meyer C, Ahmadzadehfar H, Kukuk GM, Sprinkart AM, Block W, Schild HH, Murtz P. Intravoxel Incoherent Motion Diffusion-Weighted MR Imaging for Prediction of Early Arterial Blood Flow Stasis in Radioembolization of Breast Cancer Liver Metastases. J Vasc Interv Radiol. 2016 Sep;27(9):1320-1328. doi: 10.1016/j.jvir.2016.04.018. Epub 2016 Jul 9.
PubMed 27402526Mungai F, Pasquinelli F, Mazzoni LN, Virgili G, Ragozzino A, Quaia E, Morana G, Giovagnoni A, Grazioli L, Colagrande S. Diffusion-weighted magnetic resonance imaging in the prediction and assessment of chemotherapy outcome in liver metastases. Radiol Med. 2014 Aug;119(8):625-33. doi: 10.1007/s11547-013-0379-3. Epub 2014 Jan 10.
PubMed 24408046Doudou NR, Kampo S, Liu Y, Ahmmed B, Zeng D, Zheng M, Mohamadou A, Wen QP, Wang S. Monitoring the Early Antiproliferative Effect of the Analgesic-Antitumor Peptide, BmK AGAP on Breast Cancer Using Intravoxel Incoherent Motion With a Reduced Distribution of Four b-Values. Front Physiol. 2019 Jun 21;10:708. doi: 10.3389/fphys.2019.00708. eCollection 2019.
PubMed 31293432Pieper CC, Meyer C, Sprinkart AM, Block W, Ahmadzadehfar H, Schild HH, Murtz P, Kukuk GM. The value of intravoxel incoherent motion model-based diffusion-weighted imaging for outcome prediction in resin-based radioembolization of breast cancer liver metastases. Onco Targets Ther. 2016 Jul 5;9:4089-98. doi: 10.2147/OTT.S104770. eCollection 2016.
PubMed 27462163Bai G, Wang Y, Zhu Y, Guo L. Prediction of Early Response to Chemotherapy in Breast Cancer Liver Metastases by Diffusion-Weighted MR Imaging. Technol Cancer Res Treat. 2019 Jan 1;18:1533033819842944. doi: 10.1177/1533033819842944.
PubMed 30961445Cho N, Im SA, Park IA, Lee KH, Li M, Han W, Noh DY, Moon WK. Breast cancer: early prediction of response to neoadjuvant chemotherapy using parametric response maps for MR imaging. Radiology. 2014 Aug;272(2):385-96. doi: 10.1148/radiol.14131332. Epub 2014 Apr 13.
PubMed 24738612Jun W, Cong W, Xianxin X, Daqing J. Meta-Analysis of Quantitative Dynamic Contrast-Enhanced MRI for the Assessment of Neoadjuvant Chemotherapy in Breast Cancer. Am Surg. 2019 Jun 1;85(6):645-653.
PubMed 31267907Kannan P, Kretzschmar WW, Winter H, Warren D, Bates R, Allen PD, Syed N, Irving B, Papiez BW, Kaeppler J, Markelc B, Kinchesh P, Gilchrist S, Smart S, Schnabel JA, Maughan T, Harris AL, Muschel RJ, Partridge M, Sharma RA, Kersemans V. Functional Parameters Derived from Magnetic Resonance Imaging Reflect Vascular Morphology in Preclinical Tumors and in Human Liver Metastases. Clin Cancer Res. 2018 Oct 1;24(19):4694-4704. doi: 10.1158/1078-0432.CCR-18-0033. Epub 2018 Jun 29.
PubMed 29959141De Bruyne S, Van Damme N, Smeets P, Ferdinande L, Ceelen W, Mertens J, Van de Wiele C, Troisi R, Libbrecht L, Laurent S, Geboes K, Peeters M. Value of DCE-MRI and FDG-PET/CT in the prediction of response to preoperative chemotherapy with bevacizumab for colorectal liver metastases. Br J Cancer. 2012 Jun 5;106(12):1926-33. doi: 10.1038/bjc.2012.184. Epub 2012 May 17.
PubMed 22596235
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Dynamic Contrast-enhanced Magnetic Resonance Imaging Combined With IVIM-DWI for Early Prediction of Chemosensitivity in Liver Metastasis of Breast Cance
- ClinicalTrials.gov ID
- NCT05550090
- Acronym / sponsor ID
- DreaminLMBC / ZCHBC022
- Conditions
- Metastatic Breast Cancer in the Liver
- Keywords
- Liver metastasis, Breast cancer, Efficacy prediction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 16 Sep 2022 (estimated)
- Primary completion
- 16 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 22 Sep 2022 (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.
The purpose of this study is to further use DCE-MRI and ivim-dwi to predict the chemotherapy sensitivity of liver metastasis of breast cancer at an early stage, and to predict the treatment response of tumor at an early stage by using the changes of their functional parameters, and to compare the efficacy and advantages of IVIM functional parameters and DCE-MRI parameters in predicting the efficacy.To explore the efficacy of "perfusion" and "diffusion" parameters of magnetic resonance imaging as "biomarkers" for early prediction of chemotherapy response and prognosis of breast cancer patients with liver metastasis. And to provide guidance for optimizing the clinical treatment scheme of breast cancer patients with liver metastasis.
At the same time, this study will use the method of artificial intelligence to deeply mine the images, and further find out the indicators for early prediction of the therapeutic effect of liver metastasis of breast cancer.
Detailed description
The first MR examination was arranged within 7 days before treatment (baseline). The MRI scanning sequence included conventional T1, T2 weighted imaging, T1+dynamic contrast enhanced imaging, and IVIM-DWI imaging.The second and third MR examinations were arranged within 7 days after the first chemotherapy and the second chemotherapy. The examination steps and parameters were the same as those of the first examination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with liver metastasis from breast cancer requiring antitumor therapy | – | Drug: ChemotherapyPatients with liver metastasis from breast cancer requiring antitumor therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with liver metastasis from breast cancer requiring at least 2 cycles of systemic chemotherapy
Key inclusion criteria (6 listed)
- The primary lesion was pathologically confirmed to be breast cancer, and the patients diagnosed by two imaging methods or pathologically confirmed to be liver metastasis of breast cancer had at least one liver metastasis with the longest diameter ≥ 10mm;
- No second primary malignant tumor;
- ECOG score, 0-2 ;
- The organ function is normal and can tolerate chemotherapy and other anti-tumor treatments;
- The patient plans to receive systemic chemotherapy or systemic anti-tumor treatment, and the whole process of cooperative treatment. The patient has good compliance with the planned treatment and follow-up, can understand the research process of this study and sign a written informed consent；
Key exclusion criteria (5 listed)
- For patients contraindicated to MR examination, such as built-in metal instruments and allergy to contrast agents;
- The patient had diffuse liver metastasis or the number of liver metastatic tumors was more than 5;
- Patients who cannot complete 2 cycles of chemotherapy or systemic anti-tumor treatment;
- Unable to cooperate with follow-up；
- Patients who are not suitable for the study according to the investigator.
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 |
|---|---|---|
| ChemotherapyAlso: Chemotherapy can be combined with targeted or immunotherapy or endocrine therapy.All patients were given 2 cycles of chemotherapy, including the chemotherapy recommended by the clinical treatment guidelines for advanced metastatic breast cancer, which can be combined with targeted or immune or endocrine therapy. | Drug | Patients with liver metastasis from breast cancer requiring antitumor therapy |
Primary outcome
Correlation between DCE-MRI parameters combined with IVIM parameters and short-term efficacy of chemotherapy in patients with liver metastasis of breast cancer
Time frame: September 2025
Correlation between DCE-MRI parameters (Ktrans, Ve, Kep) combined with IVIM parameters (D*, D, f) and short-term efficacy of chemotherapy in patients with liver metastasis of breast cancer
Correlation between DCE-MRI parameters combined with IVIM parameters and long-term efficacy of chemotherapy in patients with liver metastasis of breast cancer
Time frame: September 2025
Correlation between DCE-MRI parameters (Ktrans, Ve, Kep) combined with IVIM parameters (D*, D, f) and long-term efficacy of chemotherapy in patients with liver metastasis of breast cancer
2 secondary outcomes
The consistency of DCE-MRI parameters and IVIM parameters between different observers and the same observer.
Time frame: September 2025
Using artificial intelligence method to deeply mine images, find out new indicators to predict the curative effect of liver metastasis treatment of breast cancer in early stage.
Time frame: September 2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Results publication: PubMed 29464535Ruiz A, Sebagh M, Wicherts DA, Castro-Benitez C, van Hillegersberg R, Paule B, Castaing D, Vibert E, Cunha AS, Cherqui D, Morere JF, Adam R. Long-term survival and cure model following liver resection for breast cancer metastases. Breast Cancer Res Treat. 2018 Jul;170(1):89-100. doi: 10.1007/s10549-018-4714-1. Epub 2018 Feb 20.
- Results publication: PubMed 26628467Holm J, Li J, Darabi H, Eklund M, Eriksson M, Humphreys K, Hall P, Czene K. Associations of Breast Cancer Risk Prediction Tools With Tumor Characteristics and Metastasis. J Clin Oncol. 2016 Jan 20;34(3):251-8. doi: 10.1200/JCO.2015.63.0624. Epub 2015 Nov 30.
- Results publication: PubMed 20498394Kennecke H, Yerushalmi R, Woods R, Cheang MC, Voduc D, Speers CH, Nielsen TO, Gelmon K. Metastatic behavior of breast cancer subtypes. J Clin Oncol. 2010 Jul 10;28(20):3271-7. doi: 10.1200/JCO.2009.25.9820. Epub 2010 May 24.
- Results publication: PubMed 28196771Golse N, Adam R. Liver Metastases From Breast Cancer: What Role for Surgery? Indications and Results. Clin Breast Cancer. 2017 Jul;17(4):256-265. doi: 10.1016/j.clbc.2016.12.012. Epub 2017 Jan 9.
- Results publication: PubMed 23436068Varoquaux A, Rager O, Lovblad KO, Masterson K, Dulguerov P, Ratib O, Becker CD, Becker M. Functional imaging of head and neck squamous cell carcinoma with diffusion-weighted MRI and FDG PET/CT: quantitative analysis of ADC and SUV. Eur J Nucl Med Mol Imaging. 2013 Jun;40(6):842-52. doi: 10.1007/s00259-013-2351-9. Epub 2013 Feb 22.
- Results publication: PubMed 17515386Koh DM, Collins DJ. Diffusion-weighted MRI in the body: applications and challenges in oncology. AJR Am J Roentgenol. 2007 Jun;188(6):1622-35. doi: 10.2214/AJR.06.1403.
- Results publication: PubMed 27402526Pieper CC, Willinek WA, Meyer C, Ahmadzadehfar H, Kukuk GM, Sprinkart AM, Block W, Schild HH, Murtz P. Intravoxel Incoherent Motion Diffusion-Weighted MR Imaging for Prediction of Early Arterial Blood Flow Stasis in Radioembolization of Breast Cancer Liver Metastases. J Vasc Interv Radiol. 2016 Sep;27(9):1320-1328. doi: 10.1016/j.jvir.2016.04.018. Epub 2016 Jul 9.
- Results publication: PubMed 24408046Mungai F, Pasquinelli F, Mazzoni LN, Virgili G, Ragozzino A, Quaia E, Morana G, Giovagnoni A, Grazioli L, Colagrande S. Diffusion-weighted magnetic resonance imaging in the prediction and assessment of chemotherapy outcome in liver metastases. Radiol Med. 2014 Aug;119(8):625-33. doi: 10.1007/s11547-013-0379-3. Epub 2014 Jan 10.
- Results publication: PubMed 31293432Doudou NR, Kampo S, Liu Y, Ahmmed B, Zeng D, Zheng M, Mohamadou A, Wen QP, Wang S. Monitoring the Early Antiproliferative Effect of the Analgesic-Antitumor Peptide, BmK AGAP on Breast Cancer Using Intravoxel Incoherent Motion With a Reduced Distribution of Four b-Values. Front Physiol. 2019 Jun 21;10:708. doi: 10.3389/fphys.2019.00708. eCollection 2019.
- Results publication: PubMed 27462163Pieper CC, Meyer C, Sprinkart AM, Block W, Ahmadzadehfar H, Schild HH, Murtz P, Kukuk GM. The value of intravoxel incoherent motion model-based diffusion-weighted imaging for outcome prediction in resin-based radioembolization of breast cancer liver metastases. Onco Targets Ther. 2016 Jul 5;9:4089-98. doi: 10.2147/OTT.S104770. eCollection 2016.
- Results publication: PubMed 30961445Bai G, Wang Y, Zhu Y, Guo L. Prediction of Early Response to Chemotherapy in Breast Cancer Liver Metastases by Diffusion-Weighted MR Imaging. Technol Cancer Res Treat. 2019 Jan 1;18:1533033819842944. doi: 10.1177/1533033819842944.
- Results publication: PubMed 24738612Cho N, Im SA, Park IA, Lee KH, Li M, Han W, Noh DY, Moon WK. Breast cancer: early prediction of response to neoadjuvant chemotherapy using parametric response maps for MR imaging. Radiology. 2014 Aug;272(2):385-96. doi: 10.1148/radiol.14131332. Epub 2014 Apr 13.
- Individual participant dataSharing planned: Undecided. Decide whether to share individual participant data after clinical research reaches a certain stage
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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.
Ping Huang principal investigator
Zhejiang Cancer Hospital
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 Metastatic Breast Cancer in the Liver, run by Zhejiang Cancer 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 6 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 27 Sep 2022. 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 Ping Huang (+8613685766632, zlyyhp@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between DCE-MRI parameters combined with IVIM parameters and short-term efficacy of chemotherapy in patients with liver metastasis of breast cancer (time frame: September 2025). The study lists 2 primary outcomes in all. 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 NCT05550090, which also lists 18 linked publications.
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 27 Sep 2022.