Trial Outcomes & Findings for Breast VCEUS to Evaluate Early Response to Neoadjuvant Chemotherapy (NCT NCT01817374)

Results Overview

Grayscale ultrasound (standard of care) size in millimeters along the longest axis. Range of the grayscale is a minimum of 21.0 millimeters and maximum of 82 millimeters.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

Baseline (first visit)

Results posted on

2018-01-26

Participant Flow

A total of 22 patients was planned in this pilot study through the UAB Interdisciplinary Breast Center. However, due to early termination of the study, only six breast cancer patients were enrolled. Each participant received both interventions (2D ultrasound grayscale vs Definity Volume contrast enhanced ultrasound).

Recruitment for this study started in June 2015. The primary completion point was reached at July 2016, and study completion July 2016. The study was conducted at the University of Alabama at Birmingham.

Participant milestones

Participant milestones
Measure	Evaluation of VCEUS to Determine Response to Chemotherapy Patients with breast cancer receiving neoadjuvant chemotherapy will undergo 2D grayscale imaging followed by the quantitative VCEUS imaging as follows: 1. prior to initiation of treatment (baseline); 2. at 14 (± 4 days) after initiation of neoadjuvant chemotherapy (early treatment); 3. at 28 days (± 4 days) after initiation of neoadjuvant chemotherapy (inter-regimen); 4. at completion of therapy prior to definitive surgery (usually 2-3 months after initiation of treatment). Each patient will undergo a total of four VCEUS examinations. Definity (Perflutren Lipid Microspheres): This is a pilot study to evaluate quantitative VCEUS imaging for determining early breast cancer response to neoadjuvant chemotherapy, comparing results with volume change on grayscale US and planar CEUS, and correlating imaging findings with pathological response on surgical specimens.
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Breast VCEUS to Evaluate Early Response to Neoadjuvant Chemotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Evaluation of VCEUS to Determine Response to Chemotherapy n=6 Participants Patients with breast cancer receiving neoadjuvant chemotherapy will undergo quantitative VCEUS imaging and 2D grayscale imaging as follows: 1. prior to initiation of treatment (baseline); 2. at 14 (± 4 days) after initiation of neoadjuvant chemotherapy (early treatment); 3. at 28 days (± 4 days) after initiation of neoadjuvant chemotherapy (inter-regimen); 4. at completion of therapy prior to definitive surgery (usually 2-3 months after initiation of treatment). Each patient will undergo a total of four VCEUS examinations. Definity (Perflutren Lipid Microspheres): This is a pilot study to evaluate quantitative VCEUS imaging for determining early breast cancer response to neoadjuvant chemotherapy, comparing results with volume change on grayscale US and planar CEUS, and correlating imaging findings with pathological response on surgical specimens.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (first visit)

Grayscale ultrasound (standard of care) size in millimeters along the longest axis. Range of the grayscale is a minimum of 21.0 millimeters and maximum of 82 millimeters.

Outcome measures

Outcome measures
Measure	Grayscale Ultrasound n=6 Participants Patients with breast cancer receiving neoadjuvant chemotherapy will undergo a 2D grayscale imaging prior to initiation of treatment (baseline);
Tumor Volume Measure Using Grayscale US	38.2 millimeters Standard Deviation 23.9

PRIMARY outcome

Timeframe: Baseline

Population: 1 subject did not complete this timepoint due to machine down

Time of maximal perfusion relative to contrast injection. Range for time to peak intensity is a minimum of 67.5 seconds and a maximum of 99.0 seconds.

Outcome measures

Outcome measures
Measure	Grayscale Ultrasound n=5 Participants Patients with breast cancer receiving neoadjuvant chemotherapy will undergo a 2D grayscale imaging prior to initiation of treatment (baseline);
VCEUS Perfusion Time to Peak	88.5 seconds Standard Deviation 12.9

PRIMARY outcome

Timeframe: Week 2

Grayscale ultrasound (standard of care) size in millimeters along the longest axis. Range of the grayscale is a minimum of 21.0 millimeters and maximum of 82 millimeters.

Outcome measures

Outcome measures
Measure	Grayscale Ultrasound n=6 Participants Patients with breast cancer receiving neoadjuvant chemotherapy will undergo a 2D grayscale imaging prior to initiation of treatment (baseline);
Tumor Volume Measure Using Grayscale US	34.0 millimeters Standard Deviation 29.9

PRIMARY outcome

Timeframe: Week 4

Grayscale ultrasound (standard of care) size in millimeters along the longest axis. Range of the grayscale is a minimum of 21.0 millimeters and maximum of 82 millimeters.

Outcome measures

Outcome measures
Measure	Grayscale Ultrasound n=6 Participants Patients with breast cancer receiving neoadjuvant chemotherapy will undergo a 2D grayscale imaging prior to initiation of treatment (baseline);
Tumor Volume Measure Using Grayscale US	27.3 millimeters Standard Deviation 22.4

PRIMARY outcome

Timeframe: 6 months

Grayscale ultrasound (standard of care) size in millimeters along the longest axis. Range of the grayscale is a minimum of 21.0 millimeters and maximum of 82 millimeters.

Outcome measures

Outcome measures
Measure	Grayscale Ultrasound n=6 Participants Patients with breast cancer receiving neoadjuvant chemotherapy will undergo a 2D grayscale imaging prior to initiation of treatment (baseline);
Tumor Volume Measure Using Grayscale US	18.0 millimeters Standard Deviation 9.01

PRIMARY outcome

Timeframe: Week 2

Time of maximal perfusion relative to contrast injection. Range for time to peak intensity is a minimum of 67.5 seconds and a maximum of 99.0 seconds.

Outcome measures

Outcome measures
Measure	Grayscale Ultrasound n=6 Participants Patients with breast cancer receiving neoadjuvant chemotherapy will undergo a 2D grayscale imaging prior to initiation of treatment (baseline);
VCEUS Perfusion Time to Peak	85.7 seconds Standard Deviation 24.4

PRIMARY outcome

Timeframe: Week 4

Time of maximal perfusion relative to contrast injection. Range for time to peak intensity is a minimum of 67.5 seconds and a maximum of 99.0 seconds.

Outcome measures

Outcome measures
Measure	Grayscale Ultrasound n=6 Participants Patients with breast cancer receiving neoadjuvant chemotherapy will undergo a 2D grayscale imaging prior to initiation of treatment (baseline);
VCEUS Perfusion Time to Peak	88.3 seconds Standard Deviation 29.8

PRIMARY outcome

Timeframe: 6 months

Time of maximal perfusion relative to contrast injection. Range for time to peak intensity is a minimum of 67.5 seconds and a maximum of 99.0 seconds.

Outcome measures

Outcome measures
Measure	Grayscale Ultrasound n=6 Participants Patients with breast cancer receiving neoadjuvant chemotherapy will undergo a 2D grayscale imaging prior to initiation of treatment (baseline);
VCEUS Perfusion Time to Peak	105.16 seconds Standard Deviation 43.2

SECONDARY outcome

Timeframe: 6 months

Pathology residual tumor measured in millimeters

Outcome measures

Outcome measures
Measure	Grayscale Ultrasound n=6 Participants Patients with breast cancer receiving neoadjuvant chemotherapy will undergo a 2D grayscale imaging prior to initiation of treatment (baseline);
Pathology Residual Tumor	34.5 millimeters Standard Deviation 28.8

Adverse Events

Definity VCEUS

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

Marianne Vetrano

UAB Radiology Research

Phone: 205-934-4080

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place