Liquid Biopsies and Imaging in Breast Cancer (LIMA)
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|ClinicalTrials.gov Identifier: NCT04223492|
Recruitment Status : Recruiting
First Posted : January 10, 2020
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Diagnostic Test: Liquid biopsy Diagnostic Test: Multi-parametric MRI||Not Applicable|
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)
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Liquid Biopsies and Imaging in Breast Cancer|
|Actual Study Start Date :||January 2, 2019|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Neoadjuvant systemic treatment
All patients undergo standard neoadjuvant treatment and additional multi-parametric MRI and liquid biopsies during neoadjuvant treatment.
Diagnostic Test: Liquid biopsy
A blood sample containing circulating tumor DNA and circulating tumor cells.
Diagnostic Test: Multi-parametric MRI
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 [ Time Frame: After neoadjuvant treatment and surgery (approx. 6 months from diagnosis) ]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
- Radiological lesion volume on DCE MRI after NAC [ Time Frame: After neoadjuvant treatment (approx. 6 months from diagnosis) ]Measured in three dimensions as described in ACR BI-RADS Atlas® 5th Edition
- pathological complete response, defined as ypT0/ypN0 [ Time Frame: After neoadjuvant treatment and surgery (approx. 6 months from diagnosis) ]Pathological complete response, defined as ypT0/ypN0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04223492
|Contact: Liselore M Janssen, MD||+31 (0) 6 25 77 71 email@example.com|
|Contact: Britt BM Suelmann, MD||B.B.M.Suelmann@umcutrecht.nl|
|Universitair Medisch Centrum Utrecht||Recruiting|
|Utrecht, Netherlands, 3584 CX|
|Contact: Liselore M Janssen, MD +31 (0) 6 25 77 71 94 firstname.lastname@example.org|
|Principal Investigator:||Kenneth GA Gilhuijs, PhD||UMC Utrecht|