An interventional study of Liquid biopsy and Multi-parametric MRI in Breast Cancer, sponsored by UMC Utrecht. Completed at 1 site in Netherlands. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-28.
Sponsored by UMC Utrecht · Not applicable, Interventional, and Other
The aim of the study is to show proof of concept for combining multi-parametric MRI with liquid biopsies in addition to conventional clinical and pathologic information, to accurately predict response to neoadjuvant treatment for patients with primary breast cancer.
The response to neoadjuvant chemotherapy (NAC) in early stage breast cancer has important prognostic implications. Early, dynamic prediction of response allows for adaption of the treatment plan before completion, or even before the start of treatment. This strategy can help prevent overtreatment and related toxicity and correct for undertreatment with an ineffective regimen. The hypothesis of this study is that accurate dynamic response prediction may be reached by combining multi-parametric MRI with liquid biopsies prior to, during and after NAC, in addition to conventional clinical and pathological information. Magnetic resonance imaging (MRI) is non-invasive and is typically used for response evaluation in current clinical practice. It shows the size and perfusion of the tumor as they change during treatment. However, tumor size on MRI has limited predictive value for response to therapy. Multi-parametric MRI uses different imaging protocols in one session to measure more functional items than perfusion alone, addressing different aspects of tumor biology, and possibly improving predictive value. With this improvement, imaging still only visualizes macroscopic disease. Therefore, in the LIMA study, MRI will be combined with liquid biopsies containing circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA), which have both shown prognostic and predictive values in early stage breast cancer. Since the ctDNA may originate from cells in every part of the tumor, it may capture tumor heterogeneity. Liquid biopsies are minimally invasive and provide insight into microscopic tumor load and the tumor's genetic picture.
The aim of the study is to show proof of concept for combining multi-parametric MRI with liquid biopsies in addition to conventional clinical and pathologic information, to accurately predict response to neoadjuvant treatment for patients with primary breast cancer.
The LIMA is a multicenter prospective observational cohort study. Multi-parametric MRI will we performed prior to NAC, halfway and after completion of NAC. Liquid biopsies will be obtained before start of treatment, every 2 weeks during treatment and after completion of NAC. 100 patients will be enrolled in different hospitals.
Funding from the European Union Horizon 2020 research and innovation program under grant agreement no. 755333 (LIMA)
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 61 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →UMC Utrecht is the lead sponsor of 350 studies on the registry; 80 are open to participants now.
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Exclusion Criteria:
All patients undergo standard neoadjuvant treatment and additional multi-parametric MRI and liquid biopsies during neoadjuvant treatment.
Diagnostic Test: Liquid biopsy · Diagnostic Test: Multi-parametric MRI
A blood sample containing circulating tumor DNA and circulating tumor cells.
Multi-parametric MRI combines different imaging protocols in one session to measure more functional items than perfusion alone, addressing different aspects of tumor biology.
Residual Cancer Burden index in surgical resection specimen
The following parameters are required from pathologic examination in order to calculate Residual Cancer Burden (RCB) after neoadjuvant treatment: Primary tumor bed area, overall cancer cellularity (as percentage of area), percentage of cancer that is in situ disease, number of positive lymph nodes and diameter of largest metastasis. These parameters are filled in in the calculator that is available online to calculate the Residual Cancer Burden index: http://www3.mdanderson.org/app/medcalc/index.cfm?pagename=jsconvert3
Time frame: After neoadjuvant treatment and surgery (approx. 6 months from diagnosis)
Radiological lesion volume on DCE MRI after NAC
Measured in three dimensions as described in ACR BI-RADS Atlas® 5th Edition
Time frame: After neoadjuvant treatment (approx. 6 months from diagnosis)
pathological complete response, defined as ypT0/ypN0
Pathological complete response, defined as ypT0/ypN0
Time frame: After neoadjuvant treatment and surgery (approx. 6 months from diagnosis)
Plan to share: Yes — Meta-data will be made publicly available. A steering committee will assess any request for reuse of the data.
Supporting information: Study protocol, Sap
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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UMC Utrecht