Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ductal Breast Carcinoma In Situ | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytology Specimen Collection Procedure | Other | — | UNRESOLVED |
| Endocrine Therapy | Drug | Hormone Therapy | ALIAS |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Radiation Therapy | Radiation | — | UNRESOLVED |
| Therapeutic Conventional Surgery | Procedure | — | UNRESOLVED |
| Therapeutic Surgical Procedure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Arm A (MRI)
- description
- Patients undergo MRI prior to surgery. Patients undergo additional imaging and/or biopsies if indicated based on MRI.
- interventionNames
- Procedure: Magnetic Resonance Imaging
- Other: Quality-of-Life Assessment
- Other: Laboratory Biomarker Analysis
- Other: Cytology Specimen Collection Procedure
- type
- EXPERIMENTAL
- label
- Arm B (mastectomy)
- description
- Patients undergo a mastectomy. Patients do not register for Step 3.
- interventionNames
- Procedure: Therapeutic Conventional Surgery
- Other: Quality-of-Life Assessment
- Other: Laboratory Biomarker Analysis
- Other: Cytology Specimen Collection Procedure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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)
References
Publications (4)
- DERIVEDKhan 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 41100122
- DERIVEDDunsmore 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 40608342
- DERIVEDSlavkova 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 40167440
- DERIVEDLehman 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 30653209