Prospective Study of Magnetic Resonance Imaging (MRI) and Multiparameter Gene Expression Assay in Ductal Carcinoma In Situ (DCIS)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 368
- 试验地点
- 76
- 主要终点
- Proportion of patients judged to be breast conservation candidates based upon standard imaging and physical examination who convert to mastectomy in step 1 based on MRI findings
研究概览
简要总结
This clinical trial studies magnetic resonance imaging (MRI) and gene expression in diagnosing patients with abnormal cells in the breast duct that have not spread outside the duct. MRI uses radio waves and a powerful magnet linked to a computer to create detailed pictures of areas inside the body. MRI may help find and diagnose patients with breast cancer. It may also help doctors predict a patient's response to treatment and help plan the best treatment. Genetic studies may help doctors predict the outcome of treatment and the risk for disease recurrence. Performing MRI with genetic studies may help determine the best treatment for patients with breast cancer in situ.
详细描述
PRIMARY OBJECTIVES:
I. To estimate the proportion of patients with ductal carcinoma in situ (DCIS) diagnosed on core needle biopsy judged to be breast conservation candidates based upon standard imaging (mammography +/- sonography) and physical examination (a) who convert to mastectomy in step 1 based on MRI findings, and (b) who have a mastectomy as the final surgical procedure in step 2.
SECONDARY OBJECTIVES:
I. To assess the relation between baseline clinical covariates (e.g., tumor grade, necrosis, histologic type, mammographic lesion size), MRI morphologic and kinetic features, and the DCIS score.
II. To assess the diagnostic accuracy of MRI in extent of disease evaluation in patients with DCIS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Registration to Step 1:
- •Patients must have pathologically confirmed diagnosis of unilateral ductal carcinoma in situ with no evidence of microinvasive or invasive disease obtained by core needle biopsy within 4 months of registration; patients diagnosed by surgical excision are not eligible; patients with synchronous bilateral disease are not eligible; patients with synchronous bilateral disease (i.e., synchronous DCIS or invasive cancer) are not eligible
- •Patients will be staged prior to registration according to the clinical staging criteria adapted from the American Joint Committee on Cancer (AJCC) Cancer Staging Data Forms of the AJCC Cancer Staging Manual, 7th Edition, 2009; Note: For consistency purposes, AJCC 7th Edition will continue to be used throughout the entire study enrollment period
- •Required studies include a bilateral screening mammogram within 6 months and diagnostic mammogram of the affected breast within 3 months prior to registration
- •Patients must not have previous ipsilateral invasive breast cancer or DCIS
- •Patients must not have known deleterious mutations in breast cancer (BRCA) genes
- •Patients must not have received hormonal therapy (i.e., tamoxifen, raloxifene, and/or aromatase inhibitors) for prevention of breast cancer within 3 months of the biopsy documenting DCIS
- •Patients must not have history of chemotherapy for cancer within 6 months prior to registration
- •No prior history of breast radiotherapy that will prevent the use of radiotherapy for the present DCIS
- •Patients must be judged to be suitable to undergo MRI and receive the contrast agent gadolinium (exclusions follow):
- •No history of untreatable claustrophobia;
- •No presence of metallic objects or implanted medical devices in body (i.e., cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants);
- •No history of sickle cell disease;
- •No contraindication to intravenous contrast administration;
- •No known allergy-like reaction to gadolinium or moderate or severe allergic reactions to one or more allergens as defined by the American College of Radiology (ACR); patient may be eligible if willing to undergo pre-treatment as defined by the institution's policy and/or ACR guidance;
- •No findings consistent with renal failure, as determined by glomerular filtration rate (GFR) < 30 mL/min/1.73 m^2 based on a serum creatinine level obtained within 28 days prior to registration;
- •Weight lower than that allowable by the MRI table;
- •No prior MRI of the breasts within the 6 months prior to registration
- •Patients must be eligible for breast-conserving therapy (BCT) based on clinical examination and mammography; if ultrasound is performed, findings must also be consistent with eligibility for BCT
- •Patients must not have multicentric disease scheduled to undergo multiple lumpectomies; multifocal disease that can be encompassed in a single operative bed are eligible
- •Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within 3 weeks prior to registration to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:
- •Has not undergone a hysterectomy or bilateral oophorectomy; or
- •Has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
- •Women of childbearing potential must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study
- •Registration to Step 2:
- •MRI has been performed in Step 1, and additional imaging studies and biopsies performed if indicated
- •The clinician/patient has made the decision as to whether the patient will proceed to wide local excision or mastectomy
- •Registration to Step 3:
- •Patient's most recent surgery was wide local excision with or without re-excision and for which there was obtained clear (>= 2 mm) margins at breast conserving surgery, and the pathology reveals pure DCIS; patients with invasive cancer or DCIS with microinvasion will not be registered on step 3, but will be followed for clinical outcomes
- •The OncotypeDX Patient Report of the DCIS Score from the OncotypeDX Breast Cancer Assay performed by Genomic Health on the excision tissue have been uploaded by the site into the Rave electronic case report forms (eCRF)
排除标准
- 未提供
研究组 & 干预措施
Arm A (MRI)
Patients undergo MRI prior to surgery. Patients undergo additional imaging and/or biopsies if indicated based on MRI.
干预措施: Magnetic Resonance Imaging (Procedure)
Arm A (MRI)
Patients undergo MRI prior to surgery. Patients undergo additional imaging and/or biopsies if indicated based on MRI.
干预措施: Quality-of-Life Assessment (Other)
Arm A (MRI)
Patients undergo MRI prior to surgery. Patients undergo additional imaging and/or biopsies if indicated based on MRI.
干预措施: Laboratory Biomarker Analysis (Other)
Arm A (MRI)
Patients undergo MRI prior to surgery. Patients undergo additional imaging and/or biopsies if indicated based on MRI.
干预措施: Cytology Specimen Collection Procedure (Other)
Arm B (mastectomy)
Patients undergo a mastectomy. Patients do not register for Step 3.
干预措施: Therapeutic Conventional Surgery (Procedure)
Arm B (mastectomy)
Patients undergo a mastectomy. Patients do not register for Step 3.
干预措施: Quality-of-Life Assessment (Other)
Arm B (mastectomy)
Patients undergo a mastectomy. Patients do not register for Step 3.
干预措施: Laboratory Biomarker Analysis (Other)
Arm E (radiation therapy, endocrine therapy)
Patients undergo radiation therapy and endocrine therapy as directed.
干预措施: Laboratory Biomarker Analysis (Other)
Arm B (mastectomy)
Patients undergo a mastectomy. Patients do not register for Step 3.
干预措施: Cytology Specimen Collection Procedure (Other)
Arm C (wide local excision)
Patients undergo wide local excision +/- re-excision. Patients may cross-over to Arm B if mastectomy is indicated. Tissue samples collected during surgery are used to calculate the DCIS score using genetic analysis testing. Patients may then proceed to Step 3.
干预措施: Therapeutic Surgical Procedure (Procedure)
Arm C (wide local excision)
Patients undergo wide local excision +/- re-excision. Patients may cross-over to Arm B if mastectomy is indicated. Tissue samples collected during surgery are used to calculate the DCIS score using genetic analysis testing. Patients may then proceed to Step 3.
干预措施: Quality-of-Life Assessment (Other)
Arm C (wide local excision)
Patients undergo wide local excision +/- re-excision. Patients may cross-over to Arm B if mastectomy is indicated. Tissue samples collected during surgery are used to calculate the DCIS score using genetic analysis testing. Patients may then proceed to Step 3.
干预措施: Laboratory Biomarker Analysis (Other)
Arm C (wide local excision)
Patients undergo wide local excision +/- re-excision. Patients may cross-over to Arm B if mastectomy is indicated. Tissue samples collected during surgery are used to calculate the DCIS score using genetic analysis testing. Patients may then proceed to Step 3.
干预措施: Cytology Specimen Collection Procedure (Other)
Arm D (endocrine therapy)
Patients undergo endocrine therapy as directed.
干预措施: Endocrine Therapy (Drug)
Arm D (endocrine therapy)
Patients undergo endocrine therapy as directed.
干预措施: Quality-of-Life Assessment (Other)
Arm D (endocrine therapy)
Patients undergo endocrine therapy as directed.
干预措施: Laboratory Biomarker Analysis (Other)
Arm D (endocrine therapy)
Patients undergo endocrine therapy as directed.
干预措施: Cytology Specimen Collection Procedure (Other)
Arm E (radiation therapy, endocrine therapy)
Patients undergo radiation therapy and endocrine therapy as directed.
干预措施: Radiation Therapy (Radiation)
Arm E (radiation therapy, endocrine therapy)
Patients undergo radiation therapy and endocrine therapy as directed.
干预措施: Endocrine Therapy (Drug)
Arm E (radiation therapy, endocrine therapy)
Patients undergo radiation therapy and endocrine therapy as directed.
干预措施: Quality-of-Life Assessment (Other)
结局指标
主要结局
Proportion of patients judged to be breast conservation candidates based upon standard imaging and physical examination who convert to mastectomy in step 1 based on MRI findings
时间窗: After MRI (within 30 days following study entry), and prior to surgery
Proportion of patients judged to be breast conservation candidates based upon standard imaging and physical examination who have a mastectomy as the final surgical procedure in step 2
时间窗: Up to 12 months post-op
次要结局
- Factors associated with DCIS score(After surgery (DCIS Score is determined from surgical specimen))
- Proportion of patients who proceed to mastectomy after an initial attempt at wide local excision because of either inadequate tumor-free margins (< 2mm), or other reasons(Up to 12 months post-op)
- IBE rate(At 10 years)
- Diagnostic accuracy of MRI in extent of disease evaluation in patients with DCIS(Up to 12 months post-op)
- Proportion of patients who require re-operation because of inadequate excision after MRI(Up to 12 months post-op)
- Proportion of women who receive treatment that is concordant with their treatment goals and concerns(Up to 24 months post-op)
- Decision quality, assessed using the composite of knowledge score and decision process score(Up to 5 days after pre-surgical consultation)
- Patient-reported quality of life, measured using the Patient Reported Outcomes Measurement Information System (PROMIS)10 instrument(At 12 months post-op)
- Role of disease status, diagnostic test results, and surgeon recommendation as predictors of treatment received(Up to 24 months post-op)
- Proportion of women whose decision autonomy preference was concordant with perceived level of decision involvement(Up to 5 days after pre-surgical consultation)
- Role of concordance between decision autonomy preference and perceived level of decision involvement, knowledge and decision process scores as independent predictors of decision satisfaction(Assessed via questionnaire administered at first post-operative visit)
- Patient-reported quality of life, measured using the PROMIS10 instrument(At 24 months post-op)
- Patient-reported diagnostic testing burden of bilateral mammogram, MRI, and biopsies, measured by TMI(Up to 5 days after pre-surgical consultation)