Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

What Factors Affect Breast Cancer Neoadjuvant Chemotherapy Efficacy?

2 maggio 2018 aggiornato da: University of Aberdeen

What Are the Factors Affecting Neoadjuvant Chemotherapy Efficacy in Breast Cancer? A Non-invasive in Vivo Study Using Specialist Magnetic Resonance (MR) Methods

Breast cancer is the most prevalent cancer affecting women. To treat locally advanced breast cancers, neoadjuvant chemotherapy (NACT) is often carried out before surgery to reduce the tumour size to allow breast conservation surgery. However, treatment response for individual patients varies, where the tumour may not respond to treatment and the quality of patient care is compromised if the NACT treatment plan is not optimised. Therefore, the assessment of NACT efficacy is beneficial for the early identification of these patients and appropriate management of treatment.

Breast tumours have unique features compared to healthy tissue, including abnormal tissue structure and biochemical composition. With NACT there are specific changes to such tumour features indicating tumour treatment response.

The purpose of this study is to establish how the changes to breast tumour features following NACT treatment are seen in non-invasive imaging. This study will look at scans of breast tumours using magnetic resonance imaging (MRI). Changes to tissue structure will be measured by advanced diffusion MRI techniques and changes to tumour related biochemical substances will be measured by advanced magnetic resonance spectroscopy techniques. The investigators aim to assess if these techniques can provide information on the tumour treatment response following subsequent rounds of NACT treatment.

In this longitudinal study, 25 patients undergoing NACT will be recruited for four repeated MRI investigations over the course of NACT treatment. Magnetic resonance (MR) measurements of tissue microstructure and biochemical composition will be compared against histological measurements and radiological assessments of treatment response.

The study will recruit patients undergoing treatment at the NHS Grampian. This research is funded by Friends of ANCHOR, Tenovus Scotland Grampian and the NHS Grampian Endowment Research Fund.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Intervento / Trattamento

Descrizione dettagliata

In this single group longitudinal study, the investigators propose that functional images from magnetic resonance (MR) methods performed at baseline and after 6 cycles of neoadjuvant chemotherapy (NACT) are in agreement with histological findings from pre-treatment biopsy and post-treatment surgically excised tissue. MR methods will be performed at baseline (pre-treatment) and after the 1st, 3rd and 6th (post-treatment) cycles of NACT treatment. The investigators hypothesise that specific physiological changes detected through MR methods are a manifestation of tumour response to NACT confirmed by histology and radiological assessment (Hypothesis 1). The investigators further hypothesise that early sensitivity to physiological changes manifesting from tumour response to NACT can be revealed by MR measurements after the first and third cycle of treatment (Hypothesis 2).

Research Question 1: Is there a difference in physiological parameters revealed by MR measurements at baseline and after completion of NACT?

Research Question 2: Do the physiological measurements at the completion of NACT from MR measures agree with histological findings?

Research Question 3: Is there a difference between MR measurements at baseline and after the first and third cycle of NACT?

Research Question 4: Is there a difference in MR measurements at baseline, first and third cycle of NACT, between positive treatment responders and non-responders.

MR measurements will be compared against clinical and study specific results from histological analysis and radiological assessment of MRI, mammography and ultrasound measures of tumour treatment response. Information collected from a health questionnaire will supplement interpretation of the data.

To test the effects of NACT on specific aspects of tumour physiology, paired t-tests will be performed on MR measures of lactate concentration, lipid composition and diffusion parameters, between baseline and post-treatment assessments (Research Question 1).

To examine the relationship between MR measurements and histology, correlation analysis will be conducted between baseline and post-treatment assessments. MR measures will be correlated against corresponding percentage changes in histological findings between biopsy and tumour excision (Research Question 2).

To evaluate MR measures as early markers of NACT efficacy, paired t-tests will be carried out between MR measures at pre-treatment and post 1st and 3rd cycles of NACT treatment (Research Question 3), with independent group difference determined between responders and non-responders (Research Question 4).

Tipo di studio

Interventistico

Iscrizione (Anticipato)

25

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Regno Unito
    • Aberdeenshire
      • Aberdeen, Aberdeenshire, Regno Unito, AB25 2ZD
        • Reclutamento
        • NHS Grampian
        • Contatto:
        • Investigatore principale:
          • Nicholas Senn, MPhys

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

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

Inclusion Criteria:

  • Patients with pathologically confirmed invasive breast cancer undergoing neoadjuvant chemotherapy and surgery.

Exclusion Criteria:

  • Condition to contradictive to MRI investigation with contrast agent (poor renal function, contrast agent allergy, metal implants or pace maker).
  • Started hormone or chemotherapy treatment before recruitment.
  • Undergoing treatment for concurrent cancer diagnosis.
  • Marker coil contradictive to MRI investigation.

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: Scienza basilare
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Single Arm
25 patients with pathologically confirmed invasive breast cancer who will undergo neoadjuvant chemotherapy treatment (NACT) and surgery will be recruited. During the study, patients will receive the standard care and the current study will not alter the care plan offered to them. All patients in the single arm will undergo 4 magnetic resonance imaging scan sessions. Histopathological analysis will be performed on the core biopsy and tumour tissue removed in surgery. Health questionnaire will be completed by each patient.
Altro: Magnetic Resonance Imaging
Patients will undergo 4 MRI sessions during NACT treatment. The first scan will take place at treatment baseline before their first cycle of NACT treatment. The second scan will take place following the first treatment cycle prior to the second treatment cycle. Likewise, the third and last scan will take place after the third treatment cycle and sixth (final) treatment cycle prior to surgery. MRI scan sessions will be composed of research scans including diffusion and lipid profiling MR imaging methods and MR spectroscopy (MRS) methods.
Altro: Histopathological Analysis
Study specific analysis will be performed on the core biopsy and tissue removed in surgery following the completion of NACT treatment. Standard routine histological analysis will be performed, as well as study specific analysis for immunostaining, grading and slide scan imaging for measurement of cellularity markers.
Altro: Health Questionnaire
Health and demographic information will be collected.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Baseline: Water diffusion probability density function (Full-Width-At-Half-Maximum, FWHM, units of micrometre)
Lasso di tempo: Scan at pre-treatment baseline (Prior to start of Cycle 1, each cycle is 21 days)
The water diffusion probability density function will be quantified by the Full-Width-At-Half-Maximum with units of micrometre
Scan at pre-treatment baseline (Prior to start of Cycle 1, each cycle is 21 days)
Post Cycle 1: Water diffusion probability density function (Full-Width-At-Half-Maximum, FWHM, units of micrometre)
Lasso di tempo: Scan at the end of Cycle 1 (Each cycle is 21 days)
The water diffusion probability density function will be quantified by the Full-Width-At-Half-Maximum with units of micrometre
Scan at the end of Cycle 1 (Each cycle is 21 days)
Post Cycle 3: Water diffusion probability density function (Full-Width-At-Half-Maximum, FWHM, units of micrometre)
Lasso di tempo: Scan at the end of Cycle 3 (Each cycle is 21 days)
The water diffusion probability density function will be quantified by the Full-Width-At-Half-Maximum with units of micrometre
Scan at the end of Cycle 3 (Each cycle is 21 days)
Post Treatment: Water diffusion probability density function (Full-Width-At-Half-Maximum, FWHM, units of micrometre)
Lasso di tempo: Scan at the end of Cycle 6 (Each cycle is 21 days)
The water diffusion probability density function will be quantified by the Full-Width-At-Half-Maximum with units of micrometre
Scan at the end of Cycle 6 (Each cycle is 21 days)
Baseline: Water diffusivity (units of mm^2 /s)
Lasso di tempo: Scan at pre-treatment baseline (Prior to start of Cycle 1, each cycle is 21 days)
Water diffusivity with units of mm^2 /s
Scan at pre-treatment baseline (Prior to start of Cycle 1, each cycle is 21 days)
Post Cycle 1: Water diffusivity (units of mm^2 /s)
Lasso di tempo: Scan at the end of Cycle 1 (Each cycle is 21 days)
Water diffusivity with units of mm^2 /s
Scan at the end of Cycle 1 (Each cycle is 21 days)
Post Cycle 3: Water diffusivity (units of mm^2 /s)
Lasso di tempo: Scan at the end of Cycle 3 (Each cycle is 21 days)
Water diffusivity with units of mm^2 /s
Scan at the end of Cycle 3 (Each cycle is 21 days)
Post Treatment: Water diffusivity (units of mm^2 /s)
Lasso di tempo: Scan at the end of Cycle 6 (Each cycle is 21 days)
Water diffusivity with units of mm^2 /s
Scan at the end of Cycle 6 (Each cycle is 21 days)
Baseline: Lactate Concentration (units of mM)
Lasso di tempo: Scan at pre-treatment baseline (Prior to start of Cycle 1, each cycle is 21 days)
Lactate concentration with units of mM
Scan at pre-treatment baseline (Prior to start of Cycle 1, each cycle is 21 days)
Post Cycle 1: Lactate Concentration (units of mM)
Lasso di tempo: Scan at the end of Cycle 1 (Each cycle is 21 days)
Lactate concentration with units of mM
Scan at the end of Cycle 1 (Each cycle is 21 days)
Post Cycle 3: Lactate Concentration (units of mM)
Lasso di tempo: Scan at the end of Cycle 3 (Each cycle is 21 days)
Lactate concentration with units of mM
Scan at the end of Cycle 3 (Each cycle is 21 days)
Post Treatment: Lactate Concentration (units of mM)
Lasso di tempo: Scan at the end of Cycle 6 (Each cycle is 21 days)
Lactate concentration with units of mM
Scan at the end of Cycle 6 (Each cycle is 21 days)
Baseline: Lipid Peak Volume Ratio (Ratio Units)
Lasso di tempo: Scan at pre-treatment baseline (Prior to start of Cycle 1, each cycle is 21 days)
Lipid peak volume ratio value with units of ratio
Scan at pre-treatment baseline (Prior to start of Cycle 1, each cycle is 21 days)
Post Cycle 1: Lipid Peak Volume Ratio (Ratio Units)
Lasso di tempo: Scan at the end of Cycle 1 (Each cycle is 21 days)
Lipid peak volume ratio value with units of ratio
Scan at the end of Cycle 1 (Each cycle is 21 days)
Post Cycle 3: Lipid Peak Volume Ratio (Ratio Units)
Lasso di tempo: Scan at the end of Cycle 3 (Each cycle is 21 days)
Lipid peak volume ratio value with units of ratio
Scan at the end of Cycle 3 (Each cycle is 21 days)
Post Treatment: Lipid Peak Volume Ratio (Ratio Units)
Lasso di tempo: Scan at the end of Cycle 6 (Each cycle is 21 days)
Lipid peak volume ratio value with units of ratio
Scan at the end of Cycle 6 (Each cycle is 21 days)
Baseline: Fat Fraction (units of %)
Lasso di tempo: Scan at pre-treatment baseline (Prior to start of Cycle 1, each cycle is 21 days)
Fat Fraction with units of %
Scan at pre-treatment baseline (Prior to start of Cycle 1, each cycle is 21 days)
Post Cycle 1: Fat Fraction (units of %)
Lasso di tempo: Scan at the end of Cycle 1 (Each cycle is 21 days)
Fat Fraction with units of %
Scan at the end of Cycle 1 (Each cycle is 21 days)
Post Cycle 3: Fat Fraction (units of %)
Lasso di tempo: Scan at the end of Cycle 3 (Each cycle is 21 days)
Fat Fraction with units of %
Scan at the end of Cycle 3 (Each cycle is 21 days)
Post Treatment: Fat Fraction (units of %)
Lasso di tempo: Scan at the end of Cycle 6 (Each cycle is 21 days)
Fat Fraction with units of %
Scan at the end of Cycle 6 (Each cycle is 21 days)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Core Biopsy Tumour Tissue: Ki-67 Staining Percentage (units of %)
Lasso di tempo: Pre-treatment baseline biopsy (Taken prior to start of Cycle 1, each cycle is 21 days). Assessed following completion of treatment cycles and the routine reporting of core biopsy and excised tissue samples.
Ki-67 staining percentage with units of %, assessed on core biopsy tissue taken prior to start of treatment cycles.
Pre-treatment baseline biopsy (Taken prior to start of Cycle 1, each cycle is 21 days). Assessed following completion of treatment cycles and the routine reporting of core biopsy and excised tissue samples.
Excised Tumour Tissue: Ki-67 Staining Percentage (units of %)
Lasso di tempo: Post-treatment surgery excision (Post Cycle 6, each cycle is 21 days). Assessed following the completion of routine pathological reporting of the excised tissue.
Ki-67 staining percentage with units of %, assessed on excised tissue taken from surgery following completion of treatment cycles.
Post-treatment surgery excision (Post Cycle 6, each cycle is 21 days). Assessed following the completion of routine pathological reporting of the excised tissue.
Core Biopsy Tumour Tissue: Serotonin Staining Score (arbitrary units)
Lasso di tempo: Pre-treatment baseline biopsy (Taken prior to start of Cycle 1, each cycle is 21 days). Assessed following completion of treatment cycles and the routine reporting of core biopsy and excised tissue samples.
Serotonin staining score with arbitrary units (multiplication of staining percentage and stain intensity scored 1 - 3), assessed on core biopsy tissue taken prior to start of treatment cycles.
Pre-treatment baseline biopsy (Taken prior to start of Cycle 1, each cycle is 21 days). Assessed following completion of treatment cycles and the routine reporting of core biopsy and excised tissue samples.
Excised Tumour Tissue: Serotonin Staining Score (arbitrary units)
Lasso di tempo: Post-treatment surgery excision (Post Cycle 6, each cycle is 21 days). Assessed following the completion of routine pathological reporting of the excised tissue.
Serotonin staining score with arbitrary units (multiplication of staining percentage and stain intensity scored 1 - 3), assessed on excised tissue taken from surgery following completion of treatment cycles.
Post-treatment surgery excision (Post Cycle 6, each cycle is 21 days). Assessed following the completion of routine pathological reporting of the excised tissue.
Core Biopsy Tumour Tissue: Cellularity (units of %)
Lasso di tempo: Pre-treatment baseline biopsy (Taken prior to start of Cycle 1, each cycle is 21 days). Assessed following completion of treatment cycles and the routine reporting of core biopsy and excised tissue samples.
Cellularity with units of %, assessed on core biopsy taken prior to start of treatment cycles.
Pre-treatment baseline biopsy (Taken prior to start of Cycle 1, each cycle is 21 days). Assessed following completion of treatment cycles and the routine reporting of core biopsy and excised tissue samples.
Excised Tumour Tissue: Cellularity (units of %)
Lasso di tempo: Post-treatment surgery excision (Post Cycle 6, each cycle is 21 days). Assessed following the completion of routine pathological reporting of the excised tissue.
Cellularity with units of %, assessed on excised tissue taken from surgery following completion of treatment cycles.
Post-treatment surgery excision (Post Cycle 6, each cycle is 21 days). Assessed following the completion of routine pathological reporting of the excised tissue.

Collaboratori e investigatori

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

Sponsor

University of Aberdeen

Collaboratori

NHS Grampian

Investigatori

  • Cattedra di studio: Jiabao He, PhD, University of Aberdeen
  • Investigatore principale: Nicholas Senn, MPhys, University of Aberdeen

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

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 (Effettivo)

2 maggio 2018

Completamento primario (Anticipato)

1 giugno 2019

Completamento dello studio (Anticipato)

1 giugno 2019

Date di iscrizione allo studio

Primo inviato

28 marzo 2018

Primo inviato che soddisfa i criteri di controllo qualità

9 aprile 2018

Primo Inserito (Effettivo)

18 aprile 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 maggio 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 maggio 2018

Ultimo verificato

1 aprile 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2/108/7
  • 234794 (Altro identificatore: Integrated Research Approval System project ID)
  • 17/LO/1777 (Altro identificatore: Research Ethics Committee Reference)

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 .

Prove cliniche su Breast Neoplasm Malignant Breast Tissue

Prove cliniche su Magnetic Resonance Imaging

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Ecuador

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
Sottoscrivi