Trial Outcomes & Findings for Subharmonic Imaging and Pressure Estimation for Monitoring Neoadjuvant Chemotherapy (NCT NCT02115607)

Last Updated: 2025-05-06

Results Overview

To evaluate the ability of SHAPE, used with Definity, to track changes in interstitial fluid pressure (IFP) by studying women undergoing neoadjuvant chemotherapy before as well as with around 10% and 30% of the neoadjuvant chemotherapy treatment delivered and comparing results to MRI and pathology.

Recruitment status

COMPLETED

Study phase

Target enrollment

17 participants

Primary outcome timeframe

from baseline to completion of neoadjuvant chemotherapy, average of 6 months

Results posted on

2025-05-06

Participant Flow

Participant milestones

Participant milestones
Measure	Definity Infusion Infusion of Definity (Perflutren Lipid Microspheres) Definity infusion: 3 ml of Perflutren Lipid Microspheres (Definity) mixed in 50 ml of saline is infused at a rate of approximately 4ml/min
Overall Study STARTED	17
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Definity Infusion Infusion of Definity (Perflutren Lipid Microspheres) Definity infusion: 3 ml of Perflutren Lipid Microspheres (Definity) mixed in 50 ml of saline is infused at a rate of approximately 4ml/min
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Subharmonic Imaging and Pressure Estimation for Monitoring Neoadjuvant Chemotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Definity Infusion n=17 Participants Infusion of Definity (Perflutren Lipid Microspheres) Definity infusion: 3 ml of Perflutren Lipid Microspheres (Definity) mixed in 50 ml of saline is infused at a rate of approximately 4ml/min
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants

PRIMARY outcome

Timeframe: from baseline to completion of neoadjuvant chemotherapy, average of 6 months

Population: six participants were not counted in the data analysis. 2 due to technical issues, 2 withdrew due to worsening of underlying disease, and 2 stopped their nedoadjuvant chemotherapy treatment unexpectedly. Data presented below is for those who achieved Complete Response (CR)

Outcome measures

Outcome measures
Measure	Definity Infusion n=6 Participants Infusion of Definity (Perflutren Lipid Microspheres) Definity infusion: 3 ml of Perflutren Lipid Microspheres (Definity) mixed in 50 ml of saline is infused at a rate of approximately 4ml/min
Subharmonic Aided Pressure Estimation (SHAPE) After Treatment for Complete Responders 10% completion of neoadjuvant chemotherapy for	3.23 dB Standard Deviation 1.41
Subharmonic Aided Pressure Estimation (SHAPE) After Treatment for Complete Responders 30% completion of neoadjuvant chemotherapy	1.67 dB Standard Deviation 1.09

PRIMARY outcome

Timeframe: from baseline to completion of neoadjuvant chemotherapy

To evaluate the ability of SHAPE, used with Definity, to track changes in interstititial fluid (IFP) by studying women undergoing neoadjuvant chemotherapy before as well as with around 10% 30% of the neoadjuvant chemotherapy treatment delivered and after completion of the neoadjuvant chemotherapy treatment and comparing results to MRI and pathology.

Outcome measures

Outcome measures
Measure	Definity Infusion n=5 Participants Infusion of Definity (Perflutren Lipid Microspheres) Definity infusion: 3 ml of Perflutren Lipid Microspheres (Definity) mixed in 50 ml of saline is infused at a rate of approximately 4ml/min
Subharmonic Aided Pressure Estimation (SHAPE) After Treatment for Partial Responders 10% completion of neoadjuvant chemotherapy for	-0.88 dB Standard Deviation 1.46
Subharmonic Aided Pressure Estimation (SHAPE) After Treatment for Partial Responders 30% completion of neoadjuvant chemotherapy	0.06 dB Standard Deviation 0.90

SECONDARY outcome

Timeframe: From baseline to after surgery

To compare the 3D Subharmonic imaging (SHI) depiction of breast cancer angiogenesis in humans to CD31, an immunohistochemical predictor of angiogenesis.

Outcome measures

Outcome measures
Measure	Definity Infusion n=6 Participants Infusion of Definity (Perflutren Lipid Microspheres) Definity infusion: 3 ml of Perflutren Lipid Microspheres (Definity) mixed in 50 ml of saline is infused at a rate of approximately 4ml/min
Subharmonic Imaging (SHI) Depiction of Breast Cancer Angiogenesis for Complete Responders	1.1 dB Standard Deviation 1.9

SECONDARY outcome

Timeframe: After surgery; on average 6 months

Population: Data presented below is for those who achieved Partial Response (PR)

To compare the 3D SHI depiction of breast cancer angiogenesis in humans to CD31, an immunohistochemical predictor of angiogenesis.

Outcome measures

Outcome measures
Measure	Definity Infusion n=5 Participants Infusion of Definity (Perflutren Lipid Microspheres) Definity infusion: 3 ml of Perflutren Lipid Microspheres (Definity) mixed in 50 ml of saline is infused at a rate of approximately 4ml/min
SHI Depiction of Breast Cancer Angiogenesis for Partial Responders	0 dB Standard Deviation 1.2

Adverse Events

Definity Infusion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Flemming Forsberg, PhD

Sidney Kimmel Cancer Center at Thomas Jefferson University

Phone: 215-955-4870

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place