MRI and Gene Expression in Diagnosing Patients With Ductal Breast Cancer In Situ
Prospective Study of Magnetic Resonance Imaging (MRI) and Multiparameter Gene Expression Assay in Ductal Carcinoma In Situ (DCIS)
5 other identifiers
interventional
368
1 country
76
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2015
Longer than P75 for not_applicable
76 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2015
CompletedFirst Posted
Study publicly available on registry
February 2, 2015
CompletedStudy Start
First participant enrolled
March 25, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
December 19, 2025
December 1, 2025
12.6 years
January 16, 2015
December 17, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
Up to 12 months post-op
Secondary Outcomes (14)
Factors associated with DCIS score
After surgery (DCIS Score is determined from surgical specimen)
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 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 5 years
- +9 more secondary outcomes
Study Arms (5)
Arm A (MRI)
EXPERIMENTALPatients undergo MRI prior to surgery. Patients undergo additional imaging and/or biopsies if indicated based on MRI.
Arm B (mastectomy)
EXPERIMENTALPatients undergo a mastectomy. Patients do not register for Step 3.
Arm C (wide local excision)
EXPERIMENTALPatients 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.
Arm D (endocrine therapy)
EXPERIMENTALPatients undergo endocrine therapy as directed.
Arm E (radiation therapy, endocrine therapy)
EXPERIMENTALPatients undergo radiation therapy and endocrine therapy as directed.
Interventions
Undergo MRI
Undergo radiation therapy
Undergo endocrine therapy
Ancillary studies
Correlative studies
Correlative studies
Eligibility Criteria
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
- 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;
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ECOG-ACRIN Cancer Research Grouplead
- National Cancer Institute (NCI)collaborator
- Eastern Cooperative Oncology Groupcollaborator
Study Sites (76)
Kaiser Permanente-San Diego Zion
San Diego, California, 92120, United States
Kaiser Permanente-San Marcos
San Marcos, California, 92069, United States
Greenwich Hospital
Greenwich, Connecticut, 06830, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
Midstate Medical Center
Meriden, Connecticut, 06451, United States
The Hospital of Central Connecticut
New Britain, Connecticut, 06050, United States
Helen F Graham Cancer Center
Newark, Delaware, 19713, United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713, United States
Regional Hematology and Oncology PA
Newark, Delaware, 19713, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
John Fitzgerald Kennedy Medical Center
Atlantis, Florida, 33462, United States
Northwestern University
Chicago, Illinois, 60611, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Edward Hospital/Cancer Center
Naperville, Illinois, 60540, United States
Edward Hospital/Cancer Center?Plainfield
Plainfield, Illinois, 60585, United States
Springfield Clinic
Springfield, Illinois, 62703, United States
Memorial Medical Center
Springfield, Illinois, 62781, United States
IU Health West Hospital
Avon, Indiana, 46123, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Memorial Regional Cancer Center Day Road
Mishawaka, Indiana, 46544, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, 67801, United States
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, 67042, United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
Cancer Center of Kansas - Salina
Salina, Kansas, 67401, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, 67152, United States
Associates In Womens Health
Wichita, Kansas, 67208, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, 67208, United States
Cancer Center of Kansas - Main Office
Wichita, Kansas, 67214, United States
Via Christi Regional Medical Center
Wichita, Kansas, 67214, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, 67156, United States
Owensboro Health Mitchell Memorial Cancer Center
Owensboro, Kentucky, 42303, United States
Louisiana Hematology Oncology Associates LLC
Baton Rouge, Louisiana, 70809, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809, United States
Medical Oncology LLC
Baton Rouge, Louisiana, 70809, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121, United States
Peninsula Regional Medical Center
Salisbury, Maryland, 21801, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
Hunterdon Medical Center
Flemington, New Jersey, 08822, United States
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
Mount Holly, New Jersey, 08060, United States
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, 08876, United States
Virtua West Jersey Hospital Voorhees
Voorhees Township, New Jersey, 08043, United States
Albert Einstein College of Medicine
The Bronx, New York, 10461, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467-2490, United States
Cancer Care of Western North Carolina
Asheville, North Carolina, 28801, United States
Mission Hospital-Memorial Campus
Asheville, North Carolina, 28801, United States
Hope Women's Cancer Centers-Asheville
Asheville, North Carolina, 28816, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Aultman Health Foundation
Canton, Ohio, 44710, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010, United States
Easton Hospital
Easton, Pennsylvania, 18042, United States
Adams Cancer Center
Gettysburg, Pennsylvania, 17325, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Riddle Memorial Hospital
Media, Pennsylvania, 19063, United States
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Phoenixville Hospital
Phoenixville, Pennsylvania, 19460, United States
Pottstown Memorial Medical Center
Pottstown, Pennsylvania, 19464, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096, United States
WellSpan Health-York Hospital
York, Pennsylvania, 17405, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Roger Williams Medical Center
Providence, Rhode Island, 02908, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Oconomowoc Memorial Hospital-ProHealth Care Inc
Oconomowoc, Wisconsin, 53066, United States
Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401, United States
Related Publications (4)
Khan SA, Romanoff J, Gatsonis C, Rahbar H, Carlos R, Badve S, Wright J, Corsetti RL, Lehman CD, Spell DW, Han LK, Bumberry JR, Gareen I, Snyder BS, Wagner LI, Miller KD, Comstock C, Sparano JA. Radiotherapy With a 12-Gene Expression Assay for Ductal Carcinoma In Situ: A Randomized Clinical Trial. JAMA Oncol. 2025 Dec 1;11(12):1507-1511. doi: 10.1001/jamaoncol.2025.4079.
PMID: 41100122DERIVEDDunsmore VJ, Snyder BS, Gareen IF, Lehman CD, Khan SA, Romanoff J, Gatsonis C, Corsetti RL, Rahbar H, Spell DW, Han LK, Bumberry JR, Miller KD, Sparano JA, Comstock C, Park E, Wagner LI, Carlos RC. Quality of Life Among Patients With Ductal Carcinoma In Situ. JAMA Netw Open. 2025 Jul 1;8(7):e2518887. doi: 10.1001/jamanetworkopen.2025.18887.
PMID: 40608342DERIVEDSlavkova KP, Kang R, Kazerouni AS, Biswas D, Belenky V, Chitalia R, Horng H, Hirano M, Xiao J, Corsetti RL, Javid SH, Spell DW, Wolff AC, Sparano JA, Khan SA, Comstock CE, Romanoff J, Gatsonis C, Lehman CD, Partridge SC, Steingrimsson J, Kontos D, Rahbar H. MRI-based Radiomic Features for Risk Stratification of Ductal Carcinoma in Situ in a Multicenter Setting (ECOG-ACRIN E4112 Trial). Radiology. 2025 Apr;315(1):e241628. doi: 10.1148/radiol.241628.
PMID: 40167440DERIVEDLehman CD, Gatsonis C, Romanoff J, Khan SA, Carlos R, Solin LJ, Badve S, McCaskill-Stevens W, Corsetti RL, Rahbar H, Spell DW, Blankstein KB, Han LK, Sabol JL, Bumberry JR, Gareen I, Snyder BS, Wagner LI, Miller KD, Sparano JA, Comstock C. Association of Magnetic Resonance Imaging and a 12-Gene Expression Assay With Breast Ductal Carcinoma In Situ Treatment. JAMA Oncol. 2019 Jul 1;5(7):1036-1042. doi: 10.1001/jamaoncol.2018.6269.
PMID: 30653209DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Constance Lehman
ECOG-ACRIN Cancer Research Group
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2015
First Posted
February 2, 2015
Study Start
March 25, 2015
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
November 1, 2027
Last Updated
December 19, 2025
Record last verified: 2025-12