Trial Outcomes & Findings for Accuracy of Contrast-Enhanced Ultrasound for Hepatocellular Carcinoma Post TACE (NCT NCT04569799)

Results Overview

Number of lesions with residual disease identified on CEUS imaging. Residual disease is defined as enhancement within the lesion using CEUS.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

26 participants

Primary outcome timeframe

2-4 months post TACE

Results posted on

2023-11-02

Participant Flow

Diagnosis of hepatocellular carcinoma (HCC).

Unit of analysis: Number of lesions

Participant milestones

Participant milestones
Measure	Group-1 Following treatment, patients will receive their standard CT or MRI, as routinely ordered in the post-TACE setting. This imaging will be per standard protocol, as directed by hepatology or oncology services, often 2 to 4 months after the treatment. At the same visit, patients will also receive a one-time additional contrast-enhanced ultrasound (CEUS), Lumason: 2.4 mL per lesion
Overall Study STARTED	26 33
Overall Study COMPLETED	26 30
Overall Study NOT COMPLETED	0 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	Group-1 n=26 Participants Following treatment, patients will receive their standard CT or MRI, as routinely ordered in the post-TACE setting. This imaging will be per standard protocol, as directed by hepatology or oncology services, often 2 to 4 months after the treatment. At the same visit, patients will also receive a one-time additional contrast-enhanced ultrasound (CEUS), Lumason: 2.4 mL per lesion
Age, Continuous	66.6 years STANDARD_DEVIATION 7.9 • n=26 Participants
Sex: Female, Male Female	7 Participants n=26 Participants
Sex: Female, Male Male	19 Participants n=26 Participants
BMI	30.5 kg/m^2 STANDARD_DEVIATION 4.9 • n=26 Participants

PRIMARY outcome

Timeframe: 2-4 months post TACE

Population: Diagnosed with HCC with 1 or more lesions.

Number of lesions with residual disease identified on CEUS imaging. Residual disease is defined as enhancement within the lesion using CEUS.

Outcome measures

Outcome measures
Measure	Group-1 n=33 lesions Following treatment, patients will receive their standard CT or MRI, as routinely ordered in the post-TACE setting. This imaging will be per standard protocol, as directed by hepatology or oncology services, often 2 to 4 months after the treatment. At the same visit, patients will also receive a one-time additional contrast-enhanced ultrasound (CEUS), Lumason: 2.4 mL per lesion
Residual Disease on CEUS Imaging.	19 lesions

PRIMARY outcome

Timeframe: 2-4 months post-TACE

Population: Diagnosed with HCC with 1 or more lesions.

Number of lesions with residual disease identified on CT/MRI imaging. Residual disease is defined as enhancement within the lesion using CT/MRI.

Outcome measures

Outcome measures
Measure	Group-1 n=33 lesions Following treatment, patients will receive their standard CT or MRI, as routinely ordered in the post-TACE setting. This imaging will be per standard protocol, as directed by hepatology or oncology services, often 2 to 4 months after the treatment. At the same visit, patients will also receive a one-time additional contrast-enhanced ultrasound (CEUS), Lumason: 2.4 mL per lesion
Residual Disease on CT/MRI Imaging	17 lesions

PRIMARY outcome

Timeframe: 2-4 months post-TACE

Population: Diagnosed with HCC with 1 or more lesions.

Number of lesions with no viable disease identified on CEUS imaging. Non-viable disease is defined as no enhancement within the lesion using CEUS.

Outcome measures

Outcome measures
Measure	Group-1 n=33 lesions Following treatment, patients will receive their standard CT or MRI, as routinely ordered in the post-TACE setting. This imaging will be per standard protocol, as directed by hepatology or oncology services, often 2 to 4 months after the treatment. At the same visit, patients will also receive a one-time additional contrast-enhanced ultrasound (CEUS), Lumason: 2.4 mL per lesion
No Viable Disease on CEUS Imaging.	12 lesions

PRIMARY outcome

Timeframe: 2-4 months post-TACE

Population: Diagnosed with HCC with 1 or more lesions

Number of lesions with no viable disease identified on CT/MRI imaging. Non-viable disease is defined as no enhancement within the lesion using CT/MRI.

Outcome measures

Outcome measures
Measure	Group-1 n=33 lesions Following treatment, patients will receive their standard CT or MRI, as routinely ordered in the post-TACE setting. This imaging will be per standard protocol, as directed by hepatology or oncology services, often 2 to 4 months after the treatment. At the same visit, patients will also receive a one-time additional contrast-enhanced ultrasound (CEUS), Lumason: 2.4 mL per lesion
No Viable Disease on CT/MRI Imaging.	16 lesions

SECONDARY outcome

Timeframe: 4-8 months post-TACE

Population: 3 subjects did not return for routine imaging at 4-8 months.

Number of lesions missed or miscategorized on CEUS imaging.

Outcome measures

Outcome measures
Measure	Group-1 n=30 lesions Following treatment, patients will receive their standard CT or MRI, as routinely ordered in the post-TACE setting. This imaging will be per standard protocol, as directed by hepatology or oncology services, often 2 to 4 months after the treatment. At the same visit, patients will also receive a one-time additional contrast-enhanced ultrasound (CEUS), Lumason: 2.4 mL per lesion
Lesions Missed or Miscategorized on CEUS Imaging.	2 lesions

SECONDARY outcome

Timeframe: 4-8 months post-TACE

Population: 3 subjects did not return for routine imaging at 4-8 months.

Number of lesions missed or miscategorized on CT/MRI imaging.

Outcome measures

Outcome measures
Measure	Group-1 n=30 lesions Following treatment, patients will receive their standard CT or MRI, as routinely ordered in the post-TACE setting. This imaging will be per standard protocol, as directed by hepatology or oncology services, often 2 to 4 months after the treatment. At the same visit, patients will also receive a one-time additional contrast-enhanced ultrasound (CEUS), Lumason: 2.4 mL per lesion
Lesions Missed or Miscategorized on CT/MRI Imaging.	6 lesions

Adverse Events

Group-1

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

Kathryn McGillen, M.D.

Penn State Health College of Medicine

Phone: 717-531-0003

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place