NCT03070340Completed
Comparison of MRI and CEDM to Evaluate Treatment Response Before Surgery
Comparison of Breast Magnetic Resonance Imaging (MRI) and Contrast Enhanced Mammography (CEDM) to Evaluate Residual Disease Extent After Neoadjuvant Therapy (NAT)
Source: ClinicalTrials.gov · Last updated 21 Nov 2023
Brief summary (registry, in English)
The purpose of this study is to compare the diagnostic accuracy of breast magnetic resonance imaging (MRI) and contrast enhanced digital mammography (CEDM) in assessing the residual disease extent in patients who have completed neoadjuvant therapy (NAT).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 125 (actual)
- First submitted
- 28 Feb 2017
- Start date
- 28 Feb 2017
- Primary completion date
- 17 Nov 2023
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Diseases
- Childhood cancers
- NCT number
- NCT03070340
What you commit to
- Study type: Interventional
- Participants enrolled: 125
- From 28 Feb 2017 to the primary completion date, 17 Nov 2023
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known allergic reaction to gadolinium; patient may be eligible if the referring physician determines that the MRI is medically necessary and if the patient is willing to undergo pre-medication for contrast allergy
Lab values
- Women who have a contraindication to the intravenous use of iodinated contrast agent (i.e., allergy to iodinated contrast or severely impaired renal function with a creatinine level \> 1.3 or eGFR ≥45)
- Known or suspected renal impairment. Requirements for GFR prior to MRI as determined by local site standard practice
Other
- Pregnant women
- Male patients
- Presence of non MR compatible metallic objects or metallic objects that, in the opinion of the radiologist, would make MRI a contraindication
- Women who have already had their standard of care post-NAT mammogram and/or breast MRI
Who the study is looking for
- Any woman who has completed or is nearing completion of neoadjuvant therapy for breast cancer and is scheduled for a post-NAT breast MRI and mammogram
- Surgery (mastectomy or BCT) planned within 60 days of the MRI
Sex: Female · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Consent Only) Coordinator of this site? Confirm its status | Basking Ridge | United States | Unknown status |
| Memorial Sloan Kettering Commack (Consent only) Coordinator of this site? Confirm its status | Commack | United States | Unknown status |
| Memorial Sloan Kettering Westchester (Consent only) Coordinator of this site? Confirm its status | Harrison | United States | Unknown status |
| Memorial Sloan Kettering Bergen (Consent Only) Coordinator of this site? Confirm its status | Montvale | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.