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Disease Extent in Stage IV Lobular Carcinoma: the Aid of Imaging and Liquid Biopsy Analyses (DELILA)

3 giugno 2026 aggiornato da: Christine Desmedt, KU Leuven

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

43

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
  2. At least 18 years of age at the time of signing the Informed Consent Form (ICF)
  3. ECOG from 0 to 2
  4. 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.
  5. Confirmation of hormone receptor positive (HR+)/HER2- disease either on new biopsy or archival tissue (e.g. primary tumor)
  6. Multifocal or bilateral disease is allowed if all evaluated foci present with HR+/HER2- ILC
  7. Starting first line of treatment for metastatic ILC

Exclusion Criteria:

  1. Presence of a contraindication to perform WB-DWI/MRI
  2. Presence of severe claustrophobia
  3. 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
  4. Patients considered to have oligometastatic disease who are expected to undergo locoregional treatment
  5. Presence of other malignancies in recent medical history (<5 years)
  6. 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
  7. Adults who are the subject of a legal protection measure or who are unable to express their consent.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Diagnostico
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Standard-of-care Imaging + Whole-body diffusion-weighted MRI
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.
Test diagnostico: whole body diffusion weighted MRI
Frequency: at baseline, after 1 month and every 3 months until 30 months of follow-up or disease progression
Test diagnostico: ctDNA
Frequency: at baseline, after 1 month and every 3 months until 30 months of follow-up or disease progression

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
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
Lasso di tempo: At the time of progression
At the time of progression

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
ctDNA dynamics
Lasso di tempo: 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).
ctDNA levels will be assessed at baseline and every 3 months. Changes in levels will be correlated with findings on imaging.
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
Lasso di tempo: At baseline and every 3 months of treatment until disease progression or a maximum follow-up of 30 months (end of trial).
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
Lasso di tempo: At baseline and every 3 months of treatment until disease progression or a maximum follow-up of 30 months (end of trial).
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).
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
Lasso di tempo: 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 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).
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
Lasso di tempo: At baseline and after 1 month of treatment
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.
At baseline and after 1 month of treatment
Scores of psychological assessment questionnaires compared to baseline
Lasso di tempo: 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).
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.
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
Lasso di tempo: At baseline and every 3 months of treatment until disease progression or a maximum follow-up of 30 months (end of trial).
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.
At baseline and every 3 months of treatment until disease progression or a maximum follow-up of 30 months (end of trial).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

KU Leuven

Collaboratori

Jules Bordet Institute

Investigatori

  • Investigatore principale: Hans Wildiers, MD/PHD, UZ Leuven
  • Investigatore principale: Philippe Aftimos, MD, Jules Bordet Institute
  • Investigatore principale: Elia Biganzoli, PHD, University of Milan

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

30 giugno 2030

Completamento dello studio (Stimato)

30 giugno 2030

Date di iscrizione allo studio

Primo inviato

27 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 giugno 2026

Primo Inserito (Effettivo)

9 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • S71975

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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