Trial Outcomes & Findings for A Study to Assess the Effect of Y-90 Therapy on Non-target/Background Liver (NCT NCT02966223)

NCT ID: NCT02966223

Last Updated: 2020-09-25

Results Overview

Difference in regional liver function between pre and 3 months post Yttrium 90 delivery using the HIDA functional imaging scans.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2020-09-25

Participant Flow

Participant milestones

Measure	MRI and HIDA Scan MRI and HIDA scan: Pre y90 therapy each subject will undergo a HIDA and MRI scan. 3 months post Y90 - Each subject will undergo a second HIDA scan and MRI scan
Overall Study STARTED	20
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Measure	MRI and HIDA Scan MRI and HIDA scan: Pre y90 therapy each subject will undergo a HIDA and MRI scan. 3 months post Y90 - Each subject will undergo a second HIDA scan and MRI scan
Overall Study Physician Decision	3
Overall Study Withdrawal by Subject	11
Overall Study Lost to Follow-up	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	MRI and HIDA Scan n=20 Participants MRI and HIDA scan: Pre y90 therapy each subject will undergo a HIDA and MRI scan. 3 months post Y90 - Each subject will undergo a second HIDA scan and MRI scan
Age, Categorical <=18 years	0 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=20 Participants
Age, Categorical >=65 years	8 Participants n=20 Participants
Age, Continuous	66 years STANDARD_DEVIATION 8.02 • n=20 Participants
Sex: Female, Male Female	3 Participants n=20 Participants
Sex: Female, Male Male	17 Participants n=20 Participants
Region of Enrollment United States	20 Participants n=20 Participants
Enrollment	20 Participants n=20 Participants

PRIMARY outcome

Timeframe: 3 months

Population: The trial was halted prematurely because sponsor withdrew funding. There is insufficient data as funding to perform the analysis was withdrawn.

Difference in regional liver function between pre and 3 months post Yttrium 90 delivery using the HIDA functional imaging scans.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: The trial was halted prematurely because sponsor withdrew funding. There is insufficient funding for data to be analyzed properly.

Determine the difference in global liver function between pre and 3 months post Yttrium 90 delivery using the HIDA functional imaging scans.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: The trial was halted prematurely because sponsor withdrew funding. There is insufficient funding to properly analyze.

Correlation between the differences in liver function (both regional and global) with the Y 90 dose provided.

Outcome measures

Outcome data not reported

Adverse Events

MRI and HIDA Scan

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

Mark Tann, MD

Indiana University

Phone: 317- 948-8782

Email: matann@iupui.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place