Prospective Multicenter Study of the Role of Positron Emission Mammography (PEM) in Pre-Surgical Planning for Breast Cancer
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 472
- 试验地点
- 12
- 主要终点
- The primary outcome for this study will be measured by evidence of malignancy on PEM and/or MRI, confirmed by core biopsy or surgery.
研究概览
简要总结
Women with newly diagnosed breast cancer anticipating breast-conserving surgery are enrolled into the study and will undergo both high-resolution positron emission mammographic (PEM) imaging and contrast-enhanced magnetic resonance imaging (MRI) of the breast(s). The purpose of this study is to determine changes in surgical management resulting from PEM or MRI imaging as compared to conventional imaging and to determine if the changes were appropriate with histopathology as gold standard.
详细描述
Breast compression and/or immobilization during positron emission tomographic (PET) imaging has been called positron emission mammography, or "PEM," and the device used to perform the scan has been called a PEM Scanner. This protocol is designed as a prospective multi-center clinical trial to evaluate the role of high resolution PEM, used in combination with the radiotracer 2-[F-18]- fluorodeoxyglucose (FDG), in pre-surgical planning in women with newly diagnosed breast cancer who are considered candidates for breast conserving surgery (i.e. lumpectomy) after full workup with mammography, clinical breast exam, and additional US as would normally be performed. Participants will undergo both contrast enhanced MRI and PEM imaging. In order to control for potential bias in interpretation of the second examination (i.e. PEM or MRI), the order of interpretation of these examinations will be randomly assigned at study entry.The primary objective of the study is to determine changes in surgical management resulting from PEM or MRI or both, separately and in conjunction with conventional imaging and to determine whether these changes were appropriate (i.e. to excise malignancy) or inappropriate (e.g. wider excision or mastectomy for what proved to be benign disease).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who are 25 years of age or older
- •Newly diagnosed core-biopsy proven breast cancer
- •Has current mammography of all study breasts (within prior 3 months), including magnification views of suspicious calcifications (if any)
- •Recent clinical breast examination (within prior 3 months)
- •Has had full diagnostic workup with breast ultrasound (within prior 3 months) as indicated by mammographic and/or clinical findings
- •Has had percutaneous biopsy of all relevant suspicious findings on mammography, clinical examination, and ultrasound
- •After full diagnostic workup, participant is likely to be a candidate for breast conserving surgery.
- •No contraindications to breast MRI:
- •No pacemaker, aneurysm clip, or other implanted magnetic or ferromagnetic device;
- •No claustrophobia that cannot be controlled by medication with valium, ativan, or other sedative under her physician's orders;
- •Has intravenous access;
- •Weight < 300 lbs;
- •Physically able to tolerate positioning in the MRI scanner.
- •Agrees to undergo follow-up MRI or PEM at 6 months and/or MRI-guided vacuum-assisted biopsy, US-guided core biopsy, or PEM-guided biopsy if needed based on results of the MRI or PEM examination
- •Has signed study-specific consent form
- •Subject agrees to undergo a contrast-enhanced MRI and PEM scan within five business days of each other, prior to surgery.
排除标准
- •Active lactation or discontinued breastfeeding < 2 months prior
- •Age less than 25 years
- •Inability to provide informed consent
- •Prior radiation treatment to the affected breast(s)
- •Participant is scheduled for sentinel node procedure using radioactive Tc-99m within 24 hours after the scheduled PEM Flex study
- •Women planning prophylactic mastectomy without histologic confirmation
- •Individuals who are electing to undergo neoadjuvant chemotherapy prior to surgery (Note: Patients with prior contralateral breast cancer receiving chemoprevention with Tamoxifen, Arimidex, or other aromatase inhibitor are eligible)
- •Individuals who have had surgery on the study breast(s) within the past 12 months
- •Breast implant(s) in any study breast(s)
- •Women who have had distant metastatic disease either currently or in the past
- •Individuals with Type I or poorly controlled Type II diabetes mellitus
- •Individuals with a blood glucose level that is above 140 mg/dl at the time of PEM imaging
- •Has not had contrast-enhanced breast MRI or PEM within the past 12 months prior to study enrollment
- •Subject is currently enrolled in another breast imaging research study
结局指标
主要结局
The primary outcome for this study will be measured by evidence of malignancy on PEM and/or MRI, confirmed by core biopsy or surgery.
时间窗: Within 30 days (plus or minus a week) after core biopsy/surgery
次要结局
- Risk of false positive examinations with either PEM or MRI imaging with surgery as gold standard(Within the first 30 days (plus or minus 7 days) after surgery)