Predicting Neoadjuvant Chemotherapy Response by Using a Combined MRI and Scinti-Mammography (MRI-SMM) System
1 other identifier
observational
16
1 country
1
Brief Summary
The purpose of this research study is to investigate the accuracy of a breast imaging system that measures the uptake of the injected radioactive tracer by gamma-ray imaging, known as scinti-mammography (SMM), to diagnose the residual breast cancer after neoadjuvant chemotherapy (NAC) treatment by comparing to MRI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 12, 2016
CompletedFirst Posted
Study publicly available on registry
February 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 25, 2019
CompletedApril 19, 2021
April 1, 2021
3.7 years
February 12, 2016
April 15, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Diagnostic accuracy of residual breast cancer after neoadjuvant chemotherapy as assessed by MRI and scinti-mammography
Breast cancer patients receiving neoadjuvant chemotherapy will be imaged by a combined MRI and scinti-mammography (MRI-SMM) imaging system, and the diagnostic accuracy as assessed by MRI and SMM will be reported.
3 years
Study Arms (1)
Breast cancer patients receiving neoadjuvant chemotherapy
One arm: Combined MRI-SMM Imaging
Interventions
Eligibility Criteria
Breast cancer patients who elect to receive neoadjuvant chemotherapy
You may qualify if:
- A female older than 21 years of age,
- Have biopsy-proven breast cancer and decided to receive neoadjuvant chemotherapy.
- Are in good health (other than having breast cancer) and can lie still in a prone position for 45 minutes inside MRI scanner.
You may not qualify if:
- Pregnant,
- Unwilling to give informed consent,
- Have implanted prosthetic heart valves, pacemaker, neuro-stimulation devices, surgical clips (hemostatic clips) or other metallic implants,
- Have engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials (e.g. iron), or have imbedded metal fragments from military activities,
- Have received orthodontic work involving ferromagnetic materials,
- Claustrophobic (i.e. feeling very anxious in a confined small space),
- Have had allergic response to contrast agents (such as iodine or gadolinium) previously,
- Have known history of kidney diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California
Irvine, California, 92697, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2016
First Posted
February 24, 2016
Study Start
May 1, 2015
Primary Completion
January 25, 2019
Study Completion
January 25, 2019
Last Updated
April 19, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share