Clinical trial · Observational
Predicting Neoadjuvant Chemotherapy Response by Using a Combined MRI and Scinti-Mammography (MRI-SMM) System
NCT02690805CI-TRIAL-00051333completedClinicalTrials.gov clinicaltrialsProvenance
- 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)
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.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MR-compatible scinti-mammography (MRI-SMM) system | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Breast cancer patients receiving neoadjuvant chemotherapy
- description
- One arm: Combined MRI-SMM Imaging
- interventionNames
- Device: MR-compatible scinti-mammography (MRI-SMM) system
Primary outcomes (1)
- measure
- Diagnostic accuracy of residual breast cancer after neoadjuvant chemotherapy as assessed by MRI and scinti-mammography
- timeFrame
- 3 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: 1. A female older than 21 years of age, 2. Have biopsy-proven breast cancer and decided to receive neoadjuvant chemotherapy. 3. Are in good health (other than having breast cancer) and can lie still in a prone position for 45 minutes inside MRI scanner. Exclusion Criteria: 1. Pregnant, 2. Unwilling to give informed consent, 3. Have implanted prosthetic heart valves, pacemaker, neuro-stimulation devices, surgical clips (hemostatic clips) or other metallic implants, 4. 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, 5. Have received orthodontic work involving ferromagnetic materials, 6. Claustrophobic (i.e. feeling very anxious in a confined small space), 7. Have had allergic response to contrast agents (such as iodine or gadolinium) previously, 8. Have known history of kidney diseases.
References
Publications (0)
Data not yet available
No reference posted for this study.