MRI and Gene Expression in Diagnosing Patients With Ductal Breast Cancer In Situ

Running, not enrolling · Not applicable

Conditions studied: Ductal Breast Carcinoma In Situ

In brief

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.

Key facts

Study ID

NCT02352883

Run by

ECOG-ACRIN Cancer Research Group

People needed

368

Starts

2015-03-25

Expected to finish

2027-11-01

Last updated by the study team

2025-12-19

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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:

Where it is running

• Kaiser Permanente-San Marcos — San Marcos, California, United States
• Greenwich Hospital — Greenwich, Connecticut, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Midstate Medical Center — Meriden, Connecticut, United States
• The Hospital of Central Connecticut — New Britain, Connecticut, United States
• Helen F Graham Cancer Center — Newark, Delaware, United States
• Medical Oncology Hematology Consultants PA — Newark, Delaware, United States
• Regional Hematology and Oncology PA — Newark, Delaware, United States
• Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States
• John Fitzgerald Kennedy Medical Center — Atlantis, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• Ingalls Memorial Hospital — Harvey, Illinois, United States
• Edward Hospital/Cancer Center — Naperville, Illinois, United States
• Edward Hospital/Cancer Center?Plainfield — Plainfield, Illinois, United States
• Springfield Clinic — Springfield, Illinois, United States
• Memorial Medical Center — Springfield, Illinois, United States
• IU Health West Hospital — Avon, Indiana, United States
• Indiana University/Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
• Memorial Regional Cancer Center Day Road — Mishawaka, Indiana, United States
• Memorial Hospital of South Bend — South Bend, Indiana, United States
• Cancer Center of Kansas - Dodge City — Dodge City, Kansas, United States
• Cancer Center of Kansas - El Dorado — El Dorado, Kansas, United States
• Lawrence Memorial Hospital — Lawrence, Kansas, United States
• Cancer Center of Kansas - Salina — Salina, Kansas, United States
• Kaiser Permanente-San Diego Zion — San Diego, California, United States

Full record on ClinicalTrials.gov

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