ClinicalTrials.gg
Status unknownNCT05550090DreaminLMBCUpdated Sep 27, 2022

Dynamic Contrast-enhanced MRI Combined With IVIM-DWI for Early Prediction of Chemosensitivity in Liver MBC

An observational study in Metastatic Breast Cancer in the Liver, sponsored by Zhejiang Cancer Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-27.

Sponsored by Zhejiang Cancer Hospital · Observational

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Metastatic Breast Cancer in the Liver

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Keywords

  • Liver metastasis
  • Breast cancer
  • Efficacy prediction
03

In context

Breast Neoplasms

12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.

This study's planned enrollment of 40 is below the median of 184 across 2,711 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Zhejiang Cancer Hospital is the lead sponsor of 281 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with liver metastasis from breast cancer requiring at least 2 cycles of systemic chemotherapy

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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;
  2. No second primary malignant tumor;
  3. ECOG score, 0-2 ;
  4. The organ function is normal and can tolerate chemotherapy and other anti-tumor treatments;
  5. 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;
  6. Contraception during the study period and within 6 months after treatment, non lactation period.

Exclusion criteria

Exclusion Criteria:

  1. For patients contraindicated to MR examination, such as built-in metal instruments and allergy to contrast agents;
  2. The patient had diffuse liver metastasis or the number of liver metastatic tumors was more than 5;
  3. Patients who cannot complete 2 cycles of chemotherapy or systemic anti-tumor treatment;
  4. Unable to cooperate with follow-up;
  5. Patients who are not suitable for the study according to the investigator.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with liver metastasis from breast cancer requiring antitumor therapy

    Patients with liver metastasis from breast cancer requiring antitumor therapy

    Drug: Chemotherapy

Interventions

  • DrugChemotherapy

    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.

    Also known as: Chemotherapy can be combined with targeted or immunotherapy or endocrine therapy.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: September 2025

  2. 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

    Time frame: September 2025

Secondary outcomes

  1. 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.

    Time frame: September 2025

  2. 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.

    Time frame: September 2025

07

Study locations

1 of 1 sites recruiting
  • Zhejiang Cancer Hospital
    Hangzhou, Zhejiang 310022, China
    • Ping Huang · Contact · zlyyhp@163.com · +86-13685766632
    • Ping Huang · Principal investigator
    Recruiting
08

References and documents

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 29464535 ↗
  • Holm 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 26628467 ↗
  • Kennecke 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 20498394 ↗
  • Golse 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 28196771 ↗
  • Varoquaux 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 23436068 ↗
  • Koh 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 17515386 ↗
  • Pieper 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 27402526 ↗
  • Mungai 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 24408046 ↗
  • Doudou 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 31293432 ↗
  • Pieper 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 27462163 ↗
  • Bai 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 30961445 ↗
  • Cho 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 24738612 ↗
  • Jun 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 31267907 ↗
  • Kannan 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 29959141 ↗
  • De 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 ↗
  • Yu J, Xu Q, Huang DY, Song JC, Li Y, Xu LL, Shi HB. Prognostic aspects of dynamic contrast-enhanced magnetic resonance imaging in synchronous distant metastatic rectal cancer. Eur Radiol. 2017 May;27(5):1840-1847. doi: 10.1007/s00330-016-4532-y. Epub 2016 Sep 5. PubMed 27595835 ↗
  • Allarakha A, Gao Y, Jiang H, Wang GL, Wang PJ. Predictive ability of DWI/ADC and DCE-MRI kinetic parameters in differentiating benign from malignant breast lesions and in building a prediction model. Discov Med. 2019 Mar;27(148):139-152. PubMed 31095923 ↗
  • Allarakha A, Gao Y, Jiang H, Wang PJ. Prediction and prognosis of biologically aggressive breast cancers by the combination of DWI/DCE-MRI and immunohistochemical tumor markers. Discov Med. 2019 Jan;27(146):7-15. PubMed 30695671 ↗

Individual participant data

Plan to share: Undecided — Decide whether to share individual participant data after clinical research reaches a certain stage

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2022; primary completion for Sep 2025, 36 months later.

Of 1,012 non-industry observational studies under Breast Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 141. This study's planned 36 months is below that.

Counting every sponsor, half of 1,165 studies reached it within 58 months; a quarter within 26 and three quarters within 125.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 18, 2022
First posted
Sep 22, 2022
StartEst.
Sep 16, 2022
Primary completionEst.
Sep 16, 2025
CompletionEst.
Dec 30, 2025
Last update
Sep 27, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05550090
Responsible party
Huang Ping (Clinical Professor, Zhejiang Cancer Hospital) — Principal investigator
First posted
Sep 22, 2022
Start date
Sep 16, 2022 (estimated)
Primary completion
Sep 16, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Sep 27, 2022

Study contacts

Ping Huang
Contact
zlyyhp@163.com
+8613685766632
Xiaojia Wang
Contact
wxiaojia0803@163.com
+8613906500190
Ping Huang
principal investigator · Zhejiang Cancer Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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