Predicting Neoadjuvant Chemotherapy Response by Using a Combined MRI and Scinti-Mammography (MRI-SMM) System

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: MR-compatible scinti-mammography (MRI-SMM) system

Detailed Description

The optimal goal of neoadjuvant chemotherapy (NAC) for breast cancer is to achieve pathologic complete response (pCR) with the least toxicity. As more effective therapies become available, one challenge is how to evaluate the response of tumor in a timely manner, so an optimal regimen can be given to the patient. Reliable imaging methods that can monitor and predict NAC response are needed. MRI is known as the most accurate imaging modality to evaluate the response to NAC based on tumor shrinkage, but so far there is no reliable parameter that can be measured at early times after the administration of drugs to predict the final treatment outcome. Furthermore, some patients may have contradiction to receive MRI, or cannot tolerate the long scan time in a prone position. Other imaging modalities that can measure early functional (particularly metabolic) changes are being investigated, and have shown some success. In this study investigators will assess the role of an MR-compatible scinti-mammography (MRI-SMM) system for monitoring and predicting NAC response. A total of 75 breast cancer patients receiving NAC will be enrolled, and each subject will receive 3 imaging studies before, during, and after completing NAC. The aims are: 1) to compare the tumor size measured by SMM and MRI at different times; 2) to evaluate the respective diagnostic accuracy of the post-NAC residual disease measured by SMM and MRI by comparing to pathological examination results as the gold standard; 3) to investigate the respective and combined ability of MRI and SMM, based on pre-treatment and early changes in the first follow-up imaging, for predicting pathologic complete response (pCR). The diagnostic results obtained using MRI and SMM from tumors of varying stages at different times during NAC will provide important information for establishing the role of a standalone SMM system, as well as the combined MRI-SMM system, for management of breast cancer patients.

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92697
      • University of California

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Breast cancer patients who elect to receive neoadjuvant chemotherapy

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Breast cancer patients receiving neoadjuvant chemotherapy; One arm: Combined MRI-SMM Imaging	Device: MR-compatible scinti-mammography (MRI-SMM) system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of California, Irvine

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): January 25, 2019
• Study Completion (Actual): January 25, 2019

Study Registration Dates

• First Submitted: February 12, 2016
• First Submitted That Met QC Criteria: February 19, 2016
• First Posted (Estimate): February 24, 2016

Study Record Updates

• Last Update Posted (Actual): April 19, 2021
• Last Update Submitted That Met QC Criteria: April 15, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: UCI HS# 2015-1866

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No