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

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McMaster University

Status

Unknown

Conditions

Breast Cancer
Preoperative MRI
Magnetic Resonance Imaging

Treatments

Procedure: Pre-operative bilateral breast MRI

Study type

Interventional

Funder types

Other

Identifiers

NCT00801476
MRI REB 07-458

Details and patient eligibility

About

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.

Full description

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

Enrollment

44 estimated patients

Sex

Female

Ages

Under 50 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

2

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Central trial contact

Shelley A Chambers, MA

Data sourced from clinicaltrials.gov

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