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Pre-operative Magnetic Resonance Imaging (MRI) in Young Breast Cancer Patients

17. november 2009 oppdatert av: McMaster University

A Prospective Cohort Study to Evaluate the Impact of Preoperative Breast Magnetic Resonance Imaging (MRI) on Surgical Decision-Making in Young Patients With Breast Cancer

Young women with breast cancer have an increased breast tissue density and conventional imaging tests such as mammography and breast ultrasound are less sensitive and specific for detecting breast cancer than in older breast cancer patients. Breast MRI is an emerging tool that has been proven to improve the ability to identify breast cancers by determining the extent of disease and also detect multifocal, multicentric and bilateral breast cancers. To date, the role of pre-operative breast MRI is not clearly defined. The investigators are proposing a study to evaluate the impact of preoperative breast MRI on surgical decision-making in breast cancer patients <= 50 years. This may lead to improved characterization of breast cancers in these younger patients that may ultimately result in lower local recurrence rates in the future. The additional information attained through the breast MRI may also guide the use of radiation, chemotherapy and/or hormonal therapy in these patients.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Fremgangsmåte: Pre-operative bilateral breast MRI

Detaljert beskrivelse

Inclusion Criteria:

female aged ≤ 50
histologically proven invasive breast cancer

Exclusion Criteria:

Is not considered a surgical candidate
Has had prior breast cancer surgery or an excisional biopsy of the newly diagnosed lesion
Has a contraindication to undergoing breast MRI
Has inflammatory breast cancer according to the standard clinical definition
Has locally advanced breast cancer according to the standard clinical definition
Patient is pregnant
Has a psychiatric or addictive disorder that would preclude obtaining informed consent or adherence to the protocol

Studietype

Intervensjonell

Registrering (Forventet)

Fase

Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Canada
- Ontario
  - Hamilton, Ontario, Canada, L8V 5C2
    - Rekruttering
    - Juravinski Cancer Centre
    - Hovedetterforsker:
      
      Nicole Hodgson, MD
  - Hamilton, Ontario, Canada, L8N 4A6
    - Rekruttering
    - St. Josephs' Healthcare
    - Ta kontakt med:
      
      Sylvie Cornacchi
      
      Telefonnummer: 905-521-6060
      
      E-post: cornacs@mcmaster.ca
    - Hovedetterforsker:
      
      Peter Lovrics, MD
    - Underetterforsker:
      
      Barbara Heller, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Ikke eldre enn 50 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

Female aged <= 50 years
Histological proof of invasive breast cancer via fine needle aspiration or core needle biopsy
Premenopausal

Exclusion Criteria:

Patient not considered an appropriate surgical candidate; i.e., patient is not well enough to have breast cancer surgery
Patient has had prior breast cancer surgery or an excisional biopsy of the newly diagnosed cancer
Patient has a contraindication to undergoing breast MRI (i.e., pacemaker, neurodefibrillator, metallic foreign bodies, etc.)
Patient has inflammatory breast cancer according to the standard clinical definition. This is a type of breast cancer in which there is evidence of erythema and/or edema. The skin of the breast may also have changes of peau d'orange.
Patient has locally advanced breast cancer according to the standard clinical definition.
Patient is pregnant
Patient has a psychiatric or addictive disorder that would preclude them from obtaining informed consent.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Diagnostisk
Tildeling: Ikke-randomisert
Intervensjonsmodell: Enkeltgruppeoppdrag
Masking: Ingen (Open Label)

Hva måler studien?

Primære resultatmål

Resultatmål	Tidsramme
Does pre-operative magnetic resonance imaging (MRI) effect surgical management in young women with breast cancer Tidsramme: 3 months	3 months

Sekundære resultatmål

Resultatmål	Tidsramme
Proportion of patients requiring a second surgery due to positive tumour margins. Tidsramme: 3 months	3 months
Incidence of multifocal or multicentric or bilateral breast cancer found on MRI Tidsramme: After surgery	After surgery
The correlation between MRI tumour size and the pathologic tumour size after surgery. Tidsramme: 3 months	3 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

McMaster University

Etterforskere

Hovedetterforsker: Nicole Hodgson, MD, Juravinski Cancer Centre
Hovedetterforsker: Som D Mukherjee, MD, Juravinski Cancer Centre

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2008

Primær fullføring (Forventet)

1. desember 2009

Studiet fullført (Forventet)

1. mai 2010

Datoer for studieregistrering

Først innsendt

2. desember 2008

Først innsendt som oppfylte QC-kriteriene