Invasive Lobular Breast CarcinomaDELILANCT07635654
Disease Extent in Stage IV Lobular Carcinoma: the Aid of Imaging and Liquid Biopsy Analyses
A study testing whole body diffusion weighted MRI and ctDNA in people with Invasive Lobular Breast Carcinoma, run by KU Leuven.
Trial summary
Metastatic invasive lobular carcinoma (ILC) is a distinct breast cancer subtype characterized by loss of E-cadherin and a diffuse growth pattern that makes metastases difficult to detect with standard imaging such as computed tomography (CT) or 18F-Fluorodeoxyglucose Positron Emission Tomography (18F-FDG PET)/CT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Lobular Breast Carcinoma
- What is being tested?
- whole body diffusion weighted MRI and ctDNA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 30 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- At least 18 years of age at the time of signing the Informed Consent Form (ICF)
- ECOG from 0 to 2
- Patient with stage IV ILC, either de novo or after prior (curative) treatment for early ILC. Histological subtype confirmed on primary tumor or on metastatic tissue. Patients that are diagnosed with stage IV breast cancer that have a mixed ILC/IBC-NST histology of the primary tumor (mixed histology within the same primary lesion) will also be able to participate and will be analyzed in an exploratory cohort.
- Confirmation of hormone receptor positive (HR+)/HER2- disease either on new biopsy or archival tissue (e.g. primary tumor)
- Multifocal or bilateral disease is allowed if all evaluated foci present with HR+/HER2- ILC
- Starting first line of treatment for metastatic ILC
Who cannot join
- Presence of a contraindication to perform WB-DWI/MRI
- Presence of severe claustrophobia
- Presence of a contraindication to use IV contrast for CT or PET/CT (e.g. allergy, severe renal failure) in case a non-contrast PET/CT cannot be performed
- Patients considered to have oligometastatic disease who are expected to undergo locoregional treatment
- Presence of other malignancies in recent medical history (<5 years)
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive
- Adults who are the subject of a legal protection measure or who are unable to express their consent.
About this study
Metastatic invasive lobular carcinoma (ILC) is a distinct breast cancer subtype characterized by loss of E-cadherin and a diffuse growth pattern that makes metastases difficult to detect with standard imaging such as computed tomography (CT) or 18F-Fluorodeoxyglucose Positron Emission Tomography (18F-FDG PET)/CT. As a result, disease burden in patients with ILC is frequently underestimated, progression is identified later than clinically optimal, and many patients are excluded from clinical trials due to insufficiently measurable disease.
Whole-body diffusion-weighted magnetic resonance imaging (WB-DWI/MRI) is a radiation-free imaging technique that has demonstrated improved sensitivity for detecting metastases-including peritoneal, bone, and nodal disease-in ILC. Retrospective studies suggest that WB-DWI/MRI can identify clinically relevant progression not visible on standard imaging. However, prospective evidence in ILC is lacking. Circulating tumor DNA (ctDNA) has also shown promise as a minimally invasive biomarker for monitoring treatment response, with early molecular changes often preceding radiologic progression, but data specific to ILC remain limited.
Read more
The DELILA study is a prospective, multicenter clinical trial conducted at University Hospitals Leuven and Institut Jules Bordet. The study aims to enroll 43 patients starting first-line systemic therapy for metastatic hormone receptor positive human epidermal growth factor receptor 2 negative (HR+/HER2-) ILC. Participants undergo serial dual imaging-WB-DWI/MRI and standard-of-care imaging-at baseline, at 1 month, and approximately every 3 months for up to 30 months or until disease progression. At each imaging time point, blood samples are collected for ctDNA analysis and Ca15.3 tumor marker assessment. Patient-reported psychological burden related to repeated imaging and blood sampling is evaluated using validated questionnaires.
The primary objective is to assess the added value of WB-DWI/MRI in detecting disease progression that informs clinical decision-making compared to standard imaging. Secondary objectives include evaluating whether ctDNA or Ca15.3 dynamics reflect disease evolution, assessing measurability of lesions with Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and MRI-specific criteria, identifying early biomarkers of treatment response using Apparent Diffusion Coefficient (ADC) changes and ctDNA kinetics, and characterizing the psychological impact of trial procedures.
This study will provide the first adequately powered prospective evidence on the clinical utility of WB-DWI/MRI and liquid biopsy monitoring in metastatic ILC. Results may support implementation of WB-DWI/MRI as a routine imaging strategy, guide imaging frequency through biomarker-informed approaches, and improve patient experience and trial eligibility for individuals living with metastatic ILC.
- Conditions
- Invasive Lobular Breast Carcinoma
- Being tested
- whole body diffusion weighted MRI, ctDNA
- Keywords
- Invasive lobular carcinoma, Imaging, WB-DWI MRI, Liquid biopsy
- Medical subject headings
- Carcinoma, Lobular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole body diffusion weighted MRIDiagnostic test
Frequency: at baseline, after 1 month and every 3 months until 30 months of follow-up or disease progression
ctDNADiagnostic test
Frequency: at baseline, after 1 month and every 3 months until 30 months of follow-up or disease progression
| Study group | Role | What they receive |
|---|---|---|
| Standard-of-care Imaging + Whole-body diffusion-weighted MRI | Experimental | Participants will undergo dual imaging at baseline and then every three months during first-line treatment for metastatic ILC, continuing until either 30 months of follow-up or documented disease progression. At these same timepoints, ctDNA levels and Ca15.3 will also be assessed. Receives: Diagnostic Test: whole body diffusion weighted MRI; Diagnostic Test: ctDNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of cases where WB-DWI/MRI contributed solely to the decision of progression and/or treatment change assessed by questionnaires filled out by the treating oncologist at the time of progression
Measured: At the time of progression
Secondary outcomes (7)
ctDNA dynamics
ctDNA levels will be assessed at baseline and every 3 months. Changes in levels will be correlated with findings on imaging.
Measured: At baseline, after 1 month of treatment, and every 3 months of treatment until disease progression or a maximum follow-up of 30 months (end of trial).
Measurability according to RECISTv1.1 criteria
Measured: At baseline and every 3 months of treatment until disease progression or a maximum follow-up of 30 months (end of trial).
Measurability according to MRI-specific criteria
Measurability will be assessed on MRI by use of RECIST v1.1 criteria and RECISTv1.1 extended with MRI-specific criteria (similar to MY-RADS and MET-RADS-P).
Measured: At baseline and every 3 months of treatment until disease progression or a maximum follow-up of 30 months (end of trial).
Disease extent on WB-DWI/MRI compared to SOC imaging
Disease extent on whole-body DWI/MRI (WB-DWI/MRI) is analyzed and compared with standard-of-care (SOC) imaging (e.g., CT, PET/CT, bone scan) using a combination of lesion detection, segmentation, and quantitative scoring methods. First, all visible lesions are identified on WB-DWI/MRI and SOC images using predefined anatomical regions. Lesions are counted and, where feasible, segmented to estimate tumor burden (e.g., total tumor volume).
Measured: At baseline and every 3 months of treatment until disease progression or a maximum follow-up of 30 months (end of trial).
Lesion-level ADC dynamics
Quantitative assessment using ADC measurements will be incorporated to support treatment response evaluation. Diffusion-weighted images acquired at baseline and early follow-up are used to generate ADC maps; the lesion is segmented, and quantitative metrics (e.g., mean or percentile ADC) are extracted. The change in ADC (absolute or percentage) is then calculated, with a significant increase typically indicating response, while stable or decreased ADC suggests resistance.
Measured: At baseline and after 1 month of treatment
Scores of psychological assessment questionnaires compared to baseline
Anxiety related to the imaging modalities will be assessed using the STAI-6 and Likert-10 scales, including evaluation of potential stressors associated with each imaging technique. The EORTC QLQ-COMU26 questionnaire will be used to assess patients' perceptions of imaging-related communication.
Measured: At baseline, after 1 month of treatment, and every 3 months of treatment until disease progression or a maximum follow-up of 30 months (end of trial).
Scores of psychological assessment questionnaires compared between imaging modalities
Anxiety related to the imaging modalities will be assessed using the STAI-6 and Likert-10 scales, including evaluation of potential stressors associated with each imaging technique. The EORTC QLQ-COMU26 questionnaire will be used to assess patients' perceptions of imaging-related communication.
Measured: At baseline and every 3 months of treatment until disease progression or a maximum follow-up of 30 months (end of trial).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Lobular Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Jules Bordet Institute
- Responsible party
- Principal investigator, Christine Desmedt, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Hans Wildiers, MD/PHD, Principal investigator, UZ LeuvenPhilippe Aftimos, MD, Principal investigator, Jules Bordet InstituteElia Biganzoli, PHD, Principal investigator, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07635654
- Sponsor's protocol ID
- S71975
- Acronym
- DELILA
- Status last verified
- Jun 2026
- First submitted
- 27 May 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disease Extent in Stage IV Lobular Carcinoma: the Aid of Imaging and Liquid Biopsy Analyses
- ClinicalTrials.gov ID
- NCT07635654
- Acronym / sponsor ID
- DELILA / S71975
- Conditions
- Invasive Lobular Breast Carcinoma
- Keywords
- Invasive lobular carcinoma, Imaging, WB-DWI MRI, Liquid biopsy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Jules Bordet Institute
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 9 Jun 2026 (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.
Metastatic invasive lobular carcinoma (ILC) is a distinct breast cancer subtype characterized by loss of E-cadherin and a diffuse growth pattern that makes metastases difficult to detect with standard imaging such as computed tomography (CT) or 18F-Fluorodeoxyglucose Positron Emission Tomography (18F-FDG PET)/CT. As a result, disease burden in patients with ILC is frequently underestimated, progression is identified later than clinically optimal, and many patients are excluded from clinical trials due to insufficiently measurable disease.
Whole-body diffusion-weighted magnetic resonance imaging (WB-DWI/MRI) is a radiation-free imaging technique that has demonstrated improved sensitivity for detecting metastases-including peritoneal, bone, and nodal disease-in ILC. Retrospective studies suggest that WB-DWI/MRI can identify clinically relevant progression not visible on standard imaging. However, prospective evidence in ILC is lacking. Circulating tumor DNA (ctDNA) has also shown promise as a minimally invasive biomarker for monitoring treatment response, with early molecular changes often preceding radiologic progression, but data specific to ILC remain limited.
The DELILA study is a prospective, multicenter clinical trial conducted at University Hospitals Leuven and Institut Jules Bordet. The study aims to enroll 43 patients starting first-line systemic therapy for metastatic hormone receptor positive human epidermal growth factor receptor 2 negative (HR+/HER2-) ILC. Participants undergo serial dual imaging-WB-DWI/MRI and standard-of-care imaging-at baseline, at 1 month, and approximately every 3 months for up to 30 months or until disease progression. At each imaging time point, blood samples are collected for ctDNA analysis and Ca15.3 tumor marker assessment. Patient-reported psychological burden related to repeated imaging and blood sampling is evaluated using validated questionnaires.
The primary objective is to assess the added value of WB-DWI/MRI in detecting disease progression that informs clinical decision-making compared to standard imaging. Secondary objectives include evaluating whether ctDNA or Ca15.3 dynamics reflect disease evolution, assessing measurability of lesions with Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and MRI-specific criteria, identifying early biomarkers of treatment response using Apparent Diffusion Coefficient (ADC) changes and ctDNA kinetics, and characterizing the psychological impact of trial procedures.
This study will provide the first adequately powered prospective evidence on the clinical utility of WB-DWI/MRI and liquid biopsy monitoring in metastatic ILC. Results may support implementation of WB-DWI/MRI as a routine imaging strategy, guide imaging frequency through biomarker-informed approaches, and improve patient experience and trial eligibility for individuals living with metastatic ILC.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard-of-care Imaging + Whole-body diffusion-weighted MRI | Experimental | Diagnostic Test: whole body diffusion weighted MRI, Diagnostic Test: ctDNAParticipants will undergo dual imaging at baseline and then every three months during first-line treatment for metastatic ILC, continuing until either 30 months of follow-up or documented disease progression. At these same timepoints, ctDNA levels and Ca15.3 will also be assessed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- At least 18 years of age at the time of signing the Informed Consent Form (ICF)
- ECOG from 0 to 2
- Patient with stage IV ILC, either de novo or after prior (curative) treatment for early ILC. Histological subtype confirmed on primary tumor or on metastatic tissue. Patients that are diagnosed with stage IV breast cancer that have a mixed ILC/IBC-NST histology of the primary tumor (mixed histology within the same primary lesion) will also be able to participate and will be analyzed in an exploratory cohort.
- Confirmation of hormone receptor positive (HR+)/HER2- disease either on new biopsy or archival tissue (e.g. primary tumor)
Key exclusion criteria (7 listed)
- Presence of a contraindication to perform WB-DWI/MRI
- Presence of severe claustrophobia
- Presence of a contraindication to use IV contrast for CT or PET/CT (e.g. allergy, severe renal failure) in case a non-contrast PET/CT cannot be performed
- Patients considered to have oligometastatic disease who are expected to undergo locoregional treatment
- Presence of other malignancies in recent medical history (<5 years)
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 |
|---|---|---|
| whole body diffusion weighted MRIFrequency: at baseline, after 1 month and every 3 months until 30 months of follow-up or disease progression | Diagnostic test | Standard-of-care Imaging + Whole-body diffusion-weighted MRI |
| ctDNAFrequency: at baseline, after 1 month and every 3 months until 30 months of follow-up or disease progression | Diagnostic test | Standard-of-care Imaging + Whole-body diffusion-weighted MRI |
Primary outcome
Percentage of cases where WB-DWI/MRI contributed solely to the decision of progression and/or treatment change assessed by questionnaires filled out by the treating oncologist at the time of progression
Time frame: At the time of progression
7 secondary outcomes
ctDNA dynamics
Time frame: At baseline, after 1 month of treatment, and every 3 months of treatment until disease progression or a maximum follow-up of 30 months (end of trial).
Measurability according to RECISTv1.1 criteria
Time frame: At baseline and every 3 months of treatment until disease progression or a maximum follow-up of 30 months (end of trial).
Measurability according to MRI-specific criteria
Time frame: At baseline and every 3 months of treatment until disease progression or a maximum follow-up of 30 months (end of trial).
Disease extent on WB-DWI/MRI compared to SOC imaging
Time frame: At baseline and every 3 months of treatment until disease progression or a maximum follow-up of 30 months (end of trial).
Lesion-level ADC dynamics
Time frame: At baseline and after 1 month of treatment
Scores of psychological assessment questionnaires compared to baseline
Time frame: At baseline, after 1 month of treatment, and every 3 months of treatment until disease progression or a maximum follow-up of 30 months (end of trial).
Scores of psychological assessment questionnaires compared between imaging modalities
Time frame: At baseline and every 3 months of treatment until disease progression or a maximum follow-up of 30 months (end of trial).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Hans Wildiers, MD/PHD principal investigator
UZ Leuven
Philippe Aftimos, MD principal investigator
Jules Bordet Institute
Elia Biganzoli, PHD principal investigator
University of Milan
Questions about this trial
What is this clinical trial studying?
A study testing whole body diffusion weighted MRI and ctDNA in people with Invasive Lobular Breast Carcinoma, run by KU Leuven.
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 7 inclusion and 7 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: opening soon, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of cases where WB-DWI/MRI contributed solely to the decision of progression and/or treatment change assessed by questionnaires filled out by the treating oncologist at the time of progression (time frame: At the time of progression). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2026.