Trial Outcomes & Findings for Correlation of Renal Mass Pathologic Grade and Contrast Enhanced Ultrasound (CEUS) (NCT NCT03821376)

Results Overview

Ultrasound images will be reviewed for quantitative post contrast features (time to peak, mean transit time)

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

12 participants

Primary outcome timeframe

6 months

Results posted on

2024-10-10

Participant Flow

Participant milestones

Participant milestones
Measure	Renal Malignancy Patients with renal mass(es) identified by cross sectional imaging, specifically ultrasound following the intravenous injection of Lumason Contrast enhanced ultrasound with Lumason: Following consent, they will undergo contrast enhanced ultrasound of their known renal mass(es). This will be performed at University hospital following intravenous administration of Lumason (2.5 mL per injection, maximum of 2 injections per mass).
Overall Study STARTED	12
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Renal Malignancy n=12 Participants Patients with renal mass(es) identified by cross sectional imaging, specifically ultrasound following the intravenous injection of Lumason Contrast enhanced ultrasound with Lumason: Following consent, they will undergo contrast enhanced ultrasound of their known renal mass(es). This will be performed at University hospital following intravenous administration of Lumason (2.5 mL per injection, maximum of 2 injections per mass).
Age, Categorical <=18 years	0 Participants n=12 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=12 Participants
Age, Categorical >=65 years	3 Participants n=12 Participants
Sex: Female, Male Female	4 Participants n=12 Participants
Sex: Female, Male Male	8 Participants n=12 Participants
Lesion pathology WHO grade 2 lesion	6 participants n=12 Participants
Lesion pathology WHO grade 3 lesion	1 participants n=12 Participants
Lesion pathology Oncocytoma	2 participants n=12 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 9 patients who completed enrollment and proceeded to surgery; staffing and software issues precluded acquisition of quantifiable ultrasound data on all but 1 of the patients who proceeded to surgery

Ultrasound images will be reviewed for quantitative post contrast features (time to peak, mean transit time)

Outcome measures

Outcome measures
Measure	Renal Malignancy n=1 Participants Patients with renal mass(es) identified by cross sectional imaging, specifically ultrasound following the intravenous injection of Lumason Contrast enhanced ultrasound with Lumason: Following consent, they will undergo contrast enhanced ultrasound of their known renal mass(es). This will be performed at University hospital following intravenous administration of Lumason (2.5 mL per injection, maximum of 2 injections per mass).
Contrast Enhanced Ultrasound Features of Renal Masses (Time to Peak, Mean Transit Time) Time to peak enhancement (seconds)	4.76 seconds
Contrast Enhanced Ultrasound Features of Renal Masses (Time to Peak, Mean Transit Time) Mean transit time (seconds)	32.1 seconds

PRIMARY outcome

Timeframe: 6 months

Population: 9 patients who completed enrollment and proceeded to surgery; staffing and software issues precluded acquisition of quantifiable ultrasound data on all but 1 of the patients who proceeded to surgery

Ultrasound images will be reviewed for quantitative post contrast features. Specifically peak intensity, which is measured in "enhancement units." A higher value represents more blood flow to the renal mass.

Outcome measures

Outcome measures
Measure	Renal Malignancy n=1 Participants Patients with renal mass(es) identified by cross sectional imaging, specifically ultrasound following the intravenous injection of Lumason Contrast enhanced ultrasound with Lumason: Following consent, they will undergo contrast enhanced ultrasound of their known renal mass(es). This will be performed at University hospital following intravenous administration of Lumason (2.5 mL per injection, maximum of 2 injections per mass).
Contrast Enhanced Ultrasound Features of Renal Masses (Peak Intensity)	2.26 enhancement units

Adverse Events

Renal Malignancy

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

Jordan Swensson, MD

Indiana University

Phone: 317-944-1831

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place