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Using Magnetic Resonance Techniques to Improve the Characterisation and Localisation of Breast Cancer. A Pilot Observational Study Testing the Accuracy of Multifunctional Magnetic Resonance Techniques in Predicting the Presence, Distribution and Nature of Breast Lesions in Women With Known Breast Cancer


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Using Magnetic Resonance Techniques to Improve the Characterisation and Localisation of Breast Cancer. A Pilot Observational Study Testing the Accuracy of Multifunctional Magnetic Resonance Techniques in Predicting the Presence, Distribution and Nature of Breast Lesions in Women With Known Breast Cancer


OBJECTIVES:

- To determine the accuracy of multifunctional magnetic resonance (MR) in detecting,
localizing, and characterizing satellite lesions in relation to an index breast tumor
in order to improve definition of clinical target volume after local excision.

OUTLINE: Patients receive an injection of gadolinium chelate and undergo multifunctional
magnetic resonance (MR) imaging, including dynamic contrast-enhanced MR, hydrogen-MR
spectroscopy, and diffusion-weighted MRI, of the ipsilateral breast within 4 weeks before
surgery. Patients undergo a mastectomy as planned. The resected specimen is photographed,
and a histopathological analysis is performed consisting of the size and grade (if
pre-invasive or invasive disease) of each satellite lesion, classification of benign
satellite lesions, dimensions of each lesion, distance from the edge of the index tumor to
the center of each satellite lesion, and the distance from the center of the surface of the
nipple to the center of each lesion.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Biopsy-confirmed invasive ductal carcinoma of the breast

- Unifocal disease as defined by clinical examination, mammography, and ultrasound

- Patient must be proceeding to mastectomy

- Hormone receptor status unknown

- No T4d or multifocal disease (as defined on conventional imaging)

- Index tumor ≤ 4 cm in diameter

PATIENT CHARACTERISTICS:

- Menopausal status not specified

- Female

- No claustrophobia

- No cup size of DD or greater

PRIOR CONCURRENT THERAPY:

- No prior surgery to ipsilateral breast

- No prior neoadjuvant chemotherapy

- No prior ferromagnetic implants

Type of Study:

Interventional

Study Design:

Primary Purpose: Diagnostic

Outcome Measure:

Sensitivity of magnetic resonance (MR) techniques in detecting histopathologically-identified multifocal and multicentric lesions

Safety Issue:

No

Principal Investigator

Anna Kirby

Investigator Affiliation:

Royal Marsden NHS Foundation Trust

Authority:

Unspecified

Study ID:

CDR0000581176

NCT ID:

NCT00602316

Start Date:

November 2007

Completion Date:

Related Keywords:

  • Breast Cancer
  • invasive ductal breast carcinoma
  • stage IA breast cancer
  • stage IB breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • Breast Neoplasms

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