Metabolic Sodium MRI to Assess Early Response of Breast Cancer to Neoadjuvant Chemotherapy

• Sponsor: NYU Langone Health (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03750240
• Collaborator: National Institutes of Health (NIH) (NIH)
• Enrollment: 2
• Location: 1
• Arm: 1
• Actual Duration (Months): 47
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

Neoadjuvant chemotherapy (NACT) is administered to treat invasive breast cancer before surgery. It offers the opportunity to evaluate tumor response to treatment in aggressive disease, and guide additional therapies for patients with inadequate response, if detected early. Investigators propose to develop a sodium breast MRI technique that will allow to assess the early metabolic response of breast cancer to NACT, occurring before late structural changes can be detected with standard MRI.

This study will scan 12 patients using 1H/23Na MRI at 7 T and DCE MRI with triple-negative breast cancer undergoing AC-T therapy (2 months of Adriamycin + Cyclophosphamide, then 3 months of Taxol): at baseline (pre-NACT); after the first AC cycle (2 weeks); after AC treatment (2 months); after complete NACT (5 months, pre-surgery).

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Triple Negative Breast Cancer	Diagnostic Test: Sodium (Na) Magnetic Resonance Imaging (MRI); Diagnostic Test: Dynamic Contrast- Enhanced (DCE) MRI	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Metabolic Sodium MRI to Assess Early Response of Breast Cancer to Neoadjuvant Chemotherapy
• Actual Study Start Date: Jul 25, 2017
• Actual Primary Completion Date: Jun 24, 2021
• Actual Study Completion Date: Jun 24, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Triple Negative Breast Cancer Patients scanned 4 times to assess breast cancer response to NACT with the proposed method.	Diagnostic Test: Sodium (Na) Magnetic Resonance Imaging (MRI); Two Na data will be acquired: FLORET without Inversion Recovery (IR), and FLORET with IR; Diagnostic Test: 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

Outcome Measures

Primary Outcome Measures

1. Change in Tumor Size [Baseline, 2 Years]

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

Secondary Outcome Measures

1. Total Sodium Concentration (TSC) [Baseline]

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

2. Intracellular Sodium Concentration (CIC) [Baseline]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Women with no sign of breast cancer as controls

• Non-pregnant and non-lactating

• Ability to understand and willingness to sign a written consent

Exclusion Criteria:

• Contra-indications to MRI (i.e., ferromagnetic prostheses, metallic surgical implants that are not compatible with an MRI machine, claustrophobia etc.)

• Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.

• Pregnant or lactating women, women using hormonal treatment in the 6 months prior to the study.

• Women with history of breast disease, previous breast surgery, or breast implants.

• Patients with a currently active second malignancy other than non-melanoma skin cancers. Patients are not considered to have a currently active malignancy if they have completed therapy and are free of disease for 3 years.

• Psychiatric illness or other conditions and circumstances which could prevent the patient from being compliant with the protocol.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU Langone Health	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health
• National Institutes of Health (NIH)

Investigators

• Principal Investigator: Guillaume Madelin, PhD, NYU Langone Health

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 2, 2020

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT03750240
• Other Study ID Numbers: 17-00269
• First Posted: Nov 21, 2018
• Last Update Posted: Aug 24, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms

Study Results

Participant Flow

Arm/Group Title	Triple Negative Breast Cancer Patients
Arm/Group Description	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: FLORET without Inversion Recovery (IR), and 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
Period Title: Overall Study
STARTED	2
COMPLETED	0
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Triple Negative Breast Cancer Patients
Arm/Group Description	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: FLORET without Inversion Recovery (IR), and 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 Participants	2
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	54.5
Sex: Female, Male (Count of Participants)
Female	2 100%
Male	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	2 100%

Outcome Measures

1. Primary Outcome

Title	Change in Tumor Size
Description	Dynamic contrast-enhanced MRI will be used to measure tumor size before and after treatment.
Time Frame	Baseline, 2 Years

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Triple Negative Breast Cancer Patients
Arm/Group Description	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: FLORET without Inversion Recovery (IR), and 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
Measure Participants	0

2. Secondary Outcome

Title	Total Sodium Concentration (TSC)
Description	TSC was directly measured from 23Na images using a phantom calibration
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Triple Negative Breast Cancer Patients
Arm/Group Description	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: FLORET without Inversion Recovery (IR), and 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
Measure Participants	2
Participant 1	47.0 (11.1)
Participant 2	39.2 (15.2)

3. Secondary Outcome

Title	Intracellular Sodium Concentration (CIC)
Description	CIC is derived from this equation: TSC = ECV · CEC + ICV · CIC + (1 -WF) · Cfat
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Triple Negative Breast Cancer Patients
Arm/Group Description	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: FLORET without Inversion Recovery (IR), and 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
Measure Participants	2
Participant 1	29.6 (17.9)
Participant 2	27.2 (21.1)

Adverse Events

Time Frame	2 years
Arm/Group Title	Triple Negative Breast Cancer Patients
Arm/Group Description	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: FLORET without Inversion Recovery (IR), and 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
All Cause Mortality
	Triple Negative Breast Cancer Patients
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Serious Adverse Events
	Triple Negative Breast Cancer Patients
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Other (Not Including Serious) Adverse Events
	Triple Negative Breast Cancer Patients
	Affected / at Risk (%)	# Events
Total	0/2 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.