Trial Outcomes & Findings for Metabolic Sodium MRI to Assess Early Response of Breast Cancer to Neoadjuvant Chemotherapy (NCT NCT03750240)

Results Overview

Dynamic contrast-enhanced MRI will be used to measure tumor size before and after treatment.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

Baseline, 2 Years

Results posted on

2022-08-24

Participant Flow

Participant milestones

Participant milestones
Measure	Triple Negative Breast Cancer Patients scanned 4 times to assess breast cancer response to NACT with the proposed method. Sodium (Na) Magnetic Resonance Imaging (MRI): Two Na data will be acquired: 1. FLORET without Inversion Recovery (IR), and 2. FLORET with IR Dynamic Contrast- Enhanced (DCE) MRI: DCE MRI will be acquired subsequent to Na MRI to prevent influence of the contrast agent on 23 Na data
Overall Study STARTED	2
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Triple Negative Breast Cancer Patients scanned 4 times to assess breast cancer response to NACT with the proposed method. Sodium (Na) Magnetic Resonance Imaging (MRI): Two Na data will be acquired: 1. FLORET without Inversion Recovery (IR), and 2. FLORET with IR Dynamic Contrast- Enhanced (DCE) MRI: DCE MRI will be acquired subsequent to Na MRI to prevent influence of the contrast agent on 23 Na data
Overall Study Technical Difficulties	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Triple Negative Breast Cancer Patients n=2 Participants scanned 4 times to assess breast cancer response to NACT with the proposed method. Sodium (Na) Magnetic Resonance Imaging (MRI): Two Na data will be acquired: 1. FLORET without Inversion Recovery (IR), and 2. FLORET with IR Dynamic Contrast- Enhanced (DCE) MRI: DCE MRI will be acquired subsequent to Na MRI to prevent influence of the contrast agent on 23 Na data
Age, Continuous	54.5 years n=2 Participants
Sex: Female, Male Female	2 Participants n=2 Participants
Sex: Female, Male Male	0 Participants n=2 Participants
Region of Enrollment United States	2 participants n=2 Participants

PRIMARY outcome

Timeframe: Baseline, 2 Years

Population: The study was terminated due to technical difficulties; therefore, no follow-ups during or after therapy were performed with only scans at baseline

Dynamic contrast-enhanced MRI will be used to measure tumor size before and after treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

TSC was directly measured from 23Na images using a phantom calibration

Outcome measures

Outcome measures
Measure	Triple Negative Breast Cancer Patients n=2 Participants scanned 4 times to assess breast cancer response to NACT with the proposed method. Sodium (Na) Magnetic Resonance Imaging (MRI): Two Na data will be acquired: 1. FLORET without Inversion Recovery (IR), and 2. FLORET with IR Dynamic Contrast- Enhanced (DCE) MRI: DCE MRI will be acquired subsequent to Na MRI to prevent influence of the contrast agent on 23 Na data
Total Sodium Concentration (TSC) Participant 1	47.0 mM Standard Deviation 11.1
Total Sodium Concentration (TSC) Participant 2	39.2 mM Standard Deviation 15.2

SECONDARY outcome

Timeframe: Baseline

CIC is derived from this equation: TSC = ECV · CEC + ICV · CIC + (1 -WF) · Cfat

Outcome measures

Outcome measures
Measure	Triple Negative Breast Cancer Patients n=2 Participants scanned 4 times to assess breast cancer response to NACT with the proposed method. Sodium (Na) Magnetic Resonance Imaging (MRI): Two Na data will be acquired: 1. FLORET without Inversion Recovery (IR), and 2. FLORET with IR Dynamic Contrast- Enhanced (DCE) MRI: DCE MRI will be acquired subsequent to Na MRI to prevent influence of the contrast agent on 23 Na data
Intracellular Sodium Concentration (CIC) Participant 1	29.6 mM Standard Deviation 17.9
Intracellular Sodium Concentration (CIC) Participant 2	27.2 mM Standard Deviation 21.1

Adverse Events

Triple Negative Breast Cancer Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Guillaume Madelin, PhD

NYU Langone Health

Phone: (212) 263-3343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place