Trial Outcomes & Findings for TheraSphere® For Treatment of Metastases in Liver (NCT NCT04517643)

NCT ID: NCT04517643

Last Updated: 2023-10-06

Results Overview

Change in dose estimates of radioactivity from Therasphere treatment to liver tumor target, measured in Gray, will be compared at pre-treatment and up to 6 hours post-treatment. Reported as number of patients that met the criterion that the dose estimated with Tc-99m MAA SPECT was within 15% of the dose estimated from Y-90 SPECT

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 4 participants
• Primary outcome timeframe: Pre-Treatment and up to 6 hours Post-Treatment
• Results posted on: 2023-10-06

Participant Flow

Participant milestones

Measure	Therasphere Therapy All participants will receive the Therasphere Therapy. Therasphere Therapy: TheraSphere is a radiotherapy treatment for primary and secondary liver neoplasia. This is an imaging study that will examine 3-5 patients who have been treated for metastatic colorectal cancer in the liver using TheraSphere®. Participation in the study involves an additional post-treatment SPECT/CT or PET/CT scan at (0-6) hours.
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

TheraSphere® For Treatment of Metastases in Liver

Baseline characteristics by cohort

Measure	Therasphere Therapy n=4 Participants All participants will receive the Therasphere Therapy. Therasphere Therapy: TheraSphere is a radiotherapy treatment for primary and secondary liver neoplasia. This is an imaging study that will examine 3-5 patients who have been treated for metastatic colorectal cancer in the liver using TheraSphere®. Participation in the study involves an additional post-treatment SPECT/CT or PET/CT scan at (0-6) hours.
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	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race/Ethnicity, Customized white/caucasian	3 Participants n=5 Participants
Race/Ethnicity, Customized black/african american	1 Participants n=5 Participants
Region of Enrollment United States	4 Participants n=5 Participants
met enrollment criteria as per protocol	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Pre-Treatment and up to 6 hours Post-Treatment

Change in dose estimates of radioactivity from Therasphere treatment to liver tumor target, measured in Gray, will be compared at pre-treatment and up to 6 hours post-treatment.

Reported as number of patients that met the criterion that the dose estimated with Tc-99m MAA SPECT was within 15% of the dose estimated from Y-90 SPECT

Outcome measures

Measure

Therasphere Therapy n=4 Participants All participants will receive the Therasphere Therapy. Therasphere Therapy: TheraSphere is a radiotherapy treatment for primary and secondary liver neoplasia. This is an imaging study that will examine 3-5 patients who have been treated for metastatic colorectal cancer in the liver using TheraSphere®. Participation in the study involves an additional post-treatment SPECT/CT or PET/CT scan at (0-6) hours.

Number of Patients That Met the Criterion That the Dose Estimated With Tc-99m MAA SPECT Was Within 15% of the Dose Estimated From Y-90 SPECT

4 Participants

Adverse Events

Therasphere Therapy

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

Robert Hobbs

Johns Hopkins Medicine

Phone: 410-502-1229

Email: rhobbs3@jhmi.edu

Results disclosure agreements

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