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Liquid Biopsies and Imaging in Breast Cancer

NCT ID: NCT04223492

Last Updated: 2023-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-02

Study Completion Date

2022-05-16

Brief Summary

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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.

Detailed Description

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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)

Conditions

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Breast Cancer

Keywords

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Breast Cancer Neoadjuvant Response Prediction Liquid Biopsies Magnetic resonance imaging Circulating Tumor DNA

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Neoadjuvant systemic treatment

All patients undergo standard neoadjuvant treatment and additional multi-parametric MRI and liquid biopsies during neoadjuvant treatment.

Group Type OTHER

Liquid biopsy

Intervention Type DIAGNOSTIC_TEST

A blood sample containing circulating tumor DNA and circulating tumor cells.

Multi-parametric MRI

Intervention Type DIAGNOSTIC_TEST

Multi-parametric MRI combines different imaging protocols in one session to measure more functional items than perfusion alone, addressing different aspects of tumor biology.

Interventions

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Liquid biopsy

A blood sample containing circulating tumor DNA and circulating tumor cells.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Histologically proven invasive breast carcinoma
* Planned for neoadjuvant chemotherapy (and in case of a Her2-positive tumor: addition of trastuzumab and/or pertuzumab)

Exclusion Criteria

* Luminal A breast cancer (defined as: ER-positive and HER2-negative by immunohistochemistry and Bloom and Richardson grade 1 or 2)
* Inflammatory breast cancer
* Distant metastases on PET/CT
* Other active malignant disease in the past 5 years (excluded squamous cell or basal cell carcinoma of the skin)
* Pregnant or lactating women
* Contra-indications for MRI according to standard hospital guidelines
* Contra-indications for gadolinium-based contrast-agent, including known prior allergic reaction to any contrast-agent, and renal failure, defined by GFR \< 30 mL/min/1.73m2
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Horizon 2020 - European Commission

OTHER

Sponsor Role collaborator

Philips Electronics Nederland BV

INDUSTRY

Sponsor Role collaborator

Agena Bioscience GmbH

UNKNOWN

Sponsor Role collaborator

DiaDx

UNKNOWN

Sponsor Role collaborator

Stilla Technologies

UNKNOWN

Sponsor Role collaborator

ANGLE Europe Limited

UNKNOWN

Sponsor Role collaborator

ALS Automated Lab Solutions GmbH

UNKNOWN

Sponsor Role collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

Philips GmbH Innovate Technologies

UNKNOWN

Sponsor Role collaborator

Institut du Cancer de Montpellier - Val d'Aurelle

OTHER

Sponsor Role collaborator

UMC Utrecht

OTHER

Sponsor Role lead

Responsible Party

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Dr. Kenneth Gilhuijs

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kenneth GA Gilhuijs, PhD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Locations

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Universitair Medisch Centrum Utrecht

Utrecht, , Netherlands

Site Status

Countries

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Netherlands

References

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Janssen LM, Suelmann BBM, Elias SG, Janse MHA, van Diest PJ, van der Wall E, Gilhuijs KGA. Improving prediction of response to neoadjuvant treatment in patients with breast cancer by combining liquid biopsies with multiparametric MRI: protocol of the LIMA study - a multicentre prospective observational cohort study. BMJ Open. 2022 Sep 20;12(9):e061334. doi: 10.1136/bmjopen-2022-061334.

Reference Type DERIVED
PMID: 36127090 (View on PubMed)

Other Identifiers

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19-396

Identifier Type: -

Identifier Source: org_study_id