Trial Outcomes & Findings for TheraSphere Post-Approval Study to Calculate the Radiation-absorbed Dose of Tc-99m MAA. (NCT NCT05233098)

NCT ID: NCT05233098

Last Updated: 2025-03-06

Results Overview

To provide imaging data calculating radiation-delivered dose of Tc-99m MAA to the whole body.

• Recruitment status: COMPLETED
• Target enrollment: 6 participants
• Primary outcome timeframe: Immediately following
• Results posted on: 2025-03-06

Participant Flow

This study was conducted at one clinical study site, NWU in Chicago, IL USA. Six patients consented and enrolled. Patient considered enrolled at time of consent per protocol. Patient 001 withdrew consent prior to the Tc-99m MAA procedure. Five patients received protocol required imaging after Tc-99m MAA injections. Patient # Date of Enrollment: 1. Apr 4, 2022 2. Feb 4, 2023 3. Mar 4, 2023 4. Mar 14, 2023 5. May 10, 2023 6. Jun 6, 2023

Participant milestones

Measure	Clinical Cohort Patients enrolled in the study will have 3 imaging scans taken after Tc-99m MAA injection. The final scan will occur between 18 and 24 hours after Tc-99m MAA injection. Technetium-99m macroaggregated albumin (Tc-99m MAA): Patients who are being evaluated for TheraSphere administration.
Overall Study STARTED	6
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

TheraSphere Post-Approval Study to Calculate the Radiation-absorbed Dose of Tc-99m MAA.

Baseline characteristics by cohort

Measure	Clinical Cohort n=6 Participants Patients enrolled in the study will have 3 imaging scans taken after Tc-99m MAA injection. The final scan will occur between 18 and 24 hours after Tc-99m MAA injection. Technetium-99m macroaggregated albumin (Tc-99m MAA): Patients who are being evaluated for TheraSphere administration.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Sex: Female, Male Participants. · Female	1 Participants n=5 Participants
Sex: Female, Male Participants. · Male	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: Immediately following

Population: Patients who are being evaluated for TheraSphere administration.

To provide imaging data calculating radiation-delivered dose of Tc-99m MAA to the whole body.

Outcome measures

Measure	Clinical Cohort n=5 Participants First imaging scan taken after Tc-99m MAA injection.
Delivered Activity of Tc-99m MAA (MBq) for Whole Body	67.322 MBq Interval 43.22 to 85.5

PRIMARY outcome

Timeframe: Immediately following

Population: Patients who are being evaluated for TheraSphere administration.

To provide imaging data to calculate the radiation-delivered dose of Tc-99m MAA to the whole body and to potential irradiated non-liver critical organs.

Outcome measures

Measure	Clinical Cohort n=5 Participants First imaging scan taken after Tc-99m MAA injection.
Delivered Activity of Tc-99m MAA (MBq) for Non-Liver Critical Organs	6.986 MBq Interval 2.91 to 12.32

PRIMARY outcome

Timeframe: 4 hours +/- 2 hours

Population: Patients who are being evaluated for TheraSphere administration.

To provide imaging data to calculate the radiation-delivered dose of Tc-99m MAA to the whole body.

Outcome measures

Measure	Clinical Cohort n=5 Participants First imaging scan taken after Tc-99m MAA injection.
Delivered Activity of Tc-99m MAA (MBq) for Whole Body	27.978 MBq Interval 16.22 to 36.2

PRIMARY outcome

Timeframe: 4 hours +/- 2 hours

Population: Patients who are being evaluated for TheraSphere administration.

To provide imaging data to calculate the radiation-delivered dose of Tc-99m MAA to the whole body and to potential irradiated non-liver critical organs.

Outcome measures

Measure	Clinical Cohort n=5 Participants First imaging scan taken after Tc-99m MAA injection.
Delivered Activity of Tc-99m MAA (MBq) for Non-Liver Critical Organs.	8.640 MBq Interval 4.57 to 14.01

PRIMARY outcome

Timeframe: 18-24 hours

Population: Patients who are being evaluated for TheraSphere administration.

To provide imaging data calculating radiation-delivered dose of Tc-99m MAA to the whole body following injection.

Outcome measures

Measure	Clinical Cohort n=5 Participants First imaging scan taken after Tc-99m MAA injection.
Delivered Activity of Tc-99m MAA (MBq) for Whole Body.	1.694 MBq Interval 0.25 to 3.9

PRIMARY outcome

Timeframe: 18-24 hours

Population: Patients who are being evaluated for TheraSphere administration.

To provide imaging data to calculate radiation delivered dose of Tc-99m MAA to the whole body and to potential irradiated non-liver critical organs.

Outcome measures

Measure	Clinical Cohort n=5 Participants First imaging scan taken after Tc-99m MAA injection.
Delivered Activity of Tc-99m MAA (MBq) for Non-Liver Critical Organs	0.662 MBq Interval 0.11 to 1.64

PRIMARY outcome

Timeframe: Overall

Population: Patients who are being evaluated for TheraSphere administration.

To provide imaging data calculating radiation-absorbed dose of Tc-99m MAA to the whole body.

Outcome measures

Measure	Clinical Cohort n=5 Participants First imaging scan taken after Tc-99m MAA injection.
Absorbed Dose of Tc-99m MAA (mGy) for Whole Body.	10.970 mGy Interval 9.95 to 11.31

PRIMARY outcome

Timeframe: Overall

Population: Patient who are being evaluated for TheraSphere administration.

To provide imaging data calculating radiation-absorbed dose of Tc-99m MAA to Non-Liver Critical Organs.

Outcome measures

Measure	Clinical Cohort n=5 Participants First imaging scan taken after Tc-99m MAA injection.
Absorbed Dose of Tc-99m MAA (mGy) for Non-Liver Critical Organs	4.812 mGy Interval 2.68 to 8.05

PRIMARY outcome

Timeframe: Overall

Population: Patients who are being evaluated for TheraSphere administration.

To provide imaging data calculating radiation-effective does of Tc-99m MAA to Non-Liver Critical Organs.

Outcome measures

Measure	Clinical Cohort n=5 Participants First imaging scan taken after Tc-99m MAA injection.
Effective Dose of Tc-99m MAA (mSv) Whole Body	0.666 mSv Interval 0.56 to 0.78

PRIMARY outcome

Timeframe: Overall

Population: Patients who are being evaluated for TheraSphere administration.

To provide data calculating radiation-effective dose of Tc-99m MAA to Whole Body.

Outcome measures

Measure	Clinical Cohort n=5 Participants First imaging scan taken after Tc-99m MAA injection.
Effective Dose of Tc-99m MAA (mSv/mBq) for Whole Body	0.008 mSv/mBq Interval 0.008 to 0.008

PRIMARY outcome

Timeframe: Overall

Population: Patients who are being evaluated for TheraSphere administration.

To provide imaging data calculating radiation-equivalent dose of Tc-99m MAA to Non-Liver Critical Organs.

Outcome measures

Measure	Clinical Cohort n=5 Participants First imaging scan taken after Tc-99m MAA injection.
Equivalent Dose of TC-99m MAA (mSV) for Non-Liver Critical Organs	0.384 mSv Interval 0.1 to 0.65

Adverse Events

Clinical Cohort

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

Jessie Stockwell, Sr. Clinical Trial Specialist

Boston Scientific

Phone: 6126181136

Email: jessie.stockwell@bsci.com

Results disclosure agreements

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