1. Diagnostic Modalities

1.1 Diagnostic Randomized Study of Radioactive Seed Localized Breast Biopsy Versus Needle Localized Breast Biopsy in Patients with Nonpalpable Breast Lesions

Objectives

I. Compare the effect of low dose radioactive seed localized breast biopsy versus needle localized breast biopsy on operative time and tissue loss in patients with nonpalpable breast lesions.

II. Compare the cost-effectiveness of these diagnostic methods in these patients.

III. Demonstrate that radioactive seed localization allows for elimination of specimen x-ray in these patients.

IV. Demonstrate that radioactive seeds may be placed safely for 1-7 days prior to surgical removal in these patients.

Participation Criteria

• Suspicious nonpalpable breast lesion requiring breast biopsy for diagnosis
  OR
  nonpalpable breast lesion that is not amenable to core needle biopsy or advanced breast biopsy instrumentation (ABBI) excision

Randomization

Arm l:

Patients undergo radiographic placement of a radioactive seed (either iodine I 125 or palladium Pd 103) into the suspicious lesion. Patients then undergo surgery to remove the lesion along with the seed and a small margin of surrounding breast tissue followed 3 months later by a postoperative mammogram.

Arm ll:

Principal Investigator

1.2 Diagnostic Study of Magnetic Resonance Imaging in Women with Suspected Breast Tumors

Objectives

I. Evaluate the performance of breast magnetic resonance imaging (MRI) in conjunction with mammography for the detection and characterization of lesions in women with suspicious mammographic or clinical examinations.

II. Assess the incremental value of breast MRI to determine the local extent of cancer in these patients.

III. Assess the value of breast MRI to determine the prevalence and characteristics of incidental enhancing lesions in the remainder of the breast.

Participation Criteria

• Suspicious mammographic finding or palpable abnormality
  OR
  Suspicious clinical or ultrasound finding without associated benign mammographic features.
  
  
• May have more than one suspicious lesion based on mammography or clinical exam if an index lesion is present.
  
  
• Mammogram within 2 months prior to MRI scan and copy of films required of all patients 30 years of age and over.
  
  
• Eligibility maintained if patient meets above criteria and has had:
  
  
  • Breast implant
    
    
  • Prior benign excisional or core biopsy at least 6 months prior to study
    
    
  • Fine needle aspiration performed at any time
    
    
  • Cancer in the contralateral breast
    
    
  • No history of prior breast cancer in the study breast
    
    

Protocol

Patients undergo a high resolution 3D post contrast magnetic resonance imaging (MRI) scan. Patients with enhancing abnormalities undergo a dynamic scan no less than 18 hours later. Some patients may require a third scan if a core biopsy is to be performed.

Patients who are ultimately found to have cancer are assessed for extent of cancer including measurement of the index lesion and identification of other present foci of cancer in relation to the index lesion. Further histological diagnosis of index lesions is determined by MRI-guided needle localization excisional biopsy.

Patients with benign needle biopsy are followed for 2 years. Patients with benign primary lesions receive a follow up MRI scan 1 year after the initial scan. Patients with benign primary lesions and incidental enhancing lesions (IEL) are followed at 2 years. Patients with negative needle biopsies not yielding a specific diagnosis and who do not undergo subsequent excisional biopsy are followed yearly for 2 years.

Principal Investigator

Mitchell Schnall,
Ph: 215-662-7238 University of Pennsylvania Cancer Center Philadelphia, Pennsylvania

1.3 Diagnostic Study of Contrast Enhanced Power Doppler Ultrasound in Women with Primary Breast Cancer

Objectives

I. Measure blood flow of primary breast lesions and corresponding lymph nodes by Power Doppler Ultrasound (PDU) and compare this information with metastatic potential and patient survival in women with primary breast cancer.

II. Correlate intratumor/-nodal blood flow with pathological variables using standard histology and special stains in this patient population.

III. Correlate intratumor microvessel density with total tumor blood flow and with the presence of axillary lymph node metastases using this diagnostic method in these patients.

IV. Correlate tumor blood flow with various markers of angiogenesis using this diagnostic method in these patients.

V. Compare tumor blood flow as measured with PDU before and after contrast enhancement in these patients.

Participation Criteria

• Clinically suspected locally advanced breast cancer where treatment indicated is primary surgery (wide local excision or simple mastectomy) and axillary dissection (clearance).
  
  
• At least 1 month since prior core biopsy (Tru-cut) of breast cancer.

Protocol

Patients receive ultrasound contrast agent IV. An ultrasound probe with Power Doppler facility is swept over the skin surface in a standard fashion before and after contrast enhancement. Blood flow data is acquired over the volume of the mass and/or lymph nodes using a video recorder. The scanning time ranges between 5 to 15 minutes depending on the size and exact location of the breast mass and axillary lymph nodes. Within 1 week of the ultrasound, patients undergo surgery and the mass and axillary lymph nodes are removed.

Principal Investigator

Gerald Gui, Ph: +44-020-808-2383 Royal Marsden NHS Trust London, England, United Kingdom

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