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临床试验/NCT00620087
NCT00620087已完成不适用

Evaluation of a Small Field of View Gamma Camera for Scintimammography in Patients With Atypical Ductal Hyperplasia, Atypical Lobular Hyperplasia, and Lobular Carcinoma In Situ

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2003年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
66
试验地点
1
主要终点
Correlation between molecular breast imaging findings and surgical pathology

研究概览

简要总结

We aim to determine if Molecular Breast Imaging (a new nuclear medicine technique developed at Mayo) can identify malignant breast lesions in women who have atypical ductal hyperplasia, atypical lobular hyperplasia, or lobular carcinoma in situ.

详细描述

Management of atypical ductal hyperplasia (ADH), atypical lobular hyperplasia (ALH), and lobular carcinoma in situ (LCIS) diagnosed by breast needle core needle biopsy is controversial. Current practice is to recommend excisional biopsy to rule out malignant lesions, which have been reported in more than half of cases in some series. No consistent clinical, pathologic, or radiologic factors have been identified to select patients who do not require surgical excision. This is due, in part, to overlap in the mammographic features of benign and malignant lesions. Furthermore, reliance on mammography for surveillance of these high-risk patients is problematic. This highlights the need for a complementary imaging modality to improve the radiologic distinction between benign and malignant tumors and improve post-biopsy surveillance.

We are evaluating a new semiconductor-based gamma camera which we call Molecular Breast Imaging (MBI) which improves resolution by a factor of 2-3 compared to conventional gamma cameras, and, unlike mammography, is not affected by breast density. Preliminary clinical studies (IRB 0-1761-01)) have shown that scintimammography (SM) using Tc-99m sestamibi and the CZT camera (CZT-SM) has a high sensitivity and specificity for the evaluation of small (5-10 mm) lesions seen on mammography. We hypothesize that the MBI will reliably distinguish lesions that require excisional biopsy from lesions that do not. A secondary aim is to compare the role of MBI with mammography in post-biopsy surveillance.

We aim to enroll 50 Mayo patients who have received a diagnosis of ADH, ALH, or LCIS on core biopsy, who have not yet undergone excisional biopsy, and who consent to undergo MBI of both breasts. For images in which there is discordance with mammographic findings, ultrasound will be used to determine if additional abnormalities warrant excision. Using pathologic correlation, we will determine: 1) If residual foci of ADH, ALH, and LCIS are visible on MBI images; and 2) If MBI images can reliably predict contiguous or separate foci of malignant lesions in either breast.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •for Surveillance Arm:
  • •Diagnosis of biopsy-prove ADH, ALH, or LCIS within the past 5 years based on core needle biopsy and/or excisional biopsy and confirmed by a Mayo pathologist.
  • •Inclusion Criteria for Diagnostic Arm:
  • •Recent core needle biopsy of the breast demonstrating ADH, ALH, or LCIS confirmed by Mayo pathologist.

排除标准

  • •They are unable to understand and sign the consent form
  • •They are pregnant or lactating
  • •They are physically unable to sit upright and still for 40 minutes
  • •They are younger than 18 years of age.

研究组 & 干预措施

Diagnostic Arm

Other

Women with core-biopsy proven atypia, LCIS, or radial scar who have not yet undergone surgical excision were enrolled in the diagnostic arm. A molecular breast imaging study will be obtained.

干预措施: Molecular Breast Imaging (Procedure)

Surveillance arm

Other

Women with a diagnosis of ADH, ALH, or LCIS within the past 5 years were enrolled in the surveillance arm. A molecular breast imaging study was done at enrollment (Year 0) and repeated at Yer 2 and Year 4. Patients continued with routine screening mammography during this time period.

干预措施: Molecular Breast Imaging (Procedure)

Surveillance arm

Other

Women with a diagnosis of ADH, ALH, or LCIS within the past 5 years were enrolled in the surveillance arm. A molecular breast imaging study was done at enrollment (Year 0) and repeated at Yer 2 and Year 4. Patients continued with routine screening mammography during this time period.

干预措施: Screening Mammography (Procedure)

结局指标

主要结局

Correlation between molecular breast imaging findings and surgical pathology

时间窗: five years

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Deborah Rhodes

MD

Mayo Clinic

研究点 (1)

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