Trial Outcomes & Findings for Low-dose Y90 Treatment Planning for HCC (NCT NCT04172714)

Last Updated: 2022-12-06

Results Overview

Y-90 radioembolization treatment requires estimating the activity shunted from the liver to the lungs, referred to as a lung shunt fraction (LSF). It is expressed in ratios, with higher ratio meaning a higher transit of Y-90 to the lungs (worse outcome) and lower ratio, lower transit of Y-90 to the lungs (better outcome).

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

Baseline

Results posted on

2022-12-06

Participant Flow

Participant milestones

Participant milestones
Measure	Technetium-99m Macroaggregated Albumin (99mTc-MAA)/Second Mapping With Low-dose Y90 Patients will undergo standard of care mapping study with 99TC-MAA to plan for Y90 radioembolization therapy. Additionally,non-standard of care, intervention will be to do a second mapping study using SIR-spheres microspheres with low-dose Y90 (15 mCi) before the therapeutic Y90 radioembolization. Additionally, non-standard of care, intervention will be to do a second mapping study using SIR-Spheres microspheres: SIR-Spheres® Y-90 resin microspheres consist of biocompatible polymer resin microspheres of a median diameter of 32.5 microns (range between 20 and 60 microns) loaded with yttrium-90 (beta radiation penetrating an average of 2.5 mm in tissue to destroy tumor cells). The resin microspheres are small enough to become lodged in the arterioles within the growing rim of the tumor but are too large to pass through the capillaries and into the venous system. Since yttrium-90 has a half-life of 64.1 hours, most of the radiation (94%) is delivered to the tumor over 11 days.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Low-dose Y90 Treatment Planning for HCC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Technetium-99m Macroaggregated Albumin (99mTc-MAA)/ Second Mapping With Low-dose Y90 n=30 Participants Patients will undergo standard of care mapping study with 99TC-MAA to plan for Y90 radioembolization therapy. Following MAA, non-standard of care, intervention will be to do a second mapping study using SIR-spheres microspheres with low-dose Y90 (15 mCi) before the therapeutic Y90 radioembolization. SIR-Spheres microspheres: SIR-Spheres® Y-90 resin microspheres consist of biocompatible polymer resin microspheres of a median diameter of 32.5 microns (range between 20 and 60 microns) loaded with yttrium-90 (beta radiation penetrating an average of 2.5 mm in tissue to destroy tumor cells). The resin microspheres are small enough to become lodged in the arterioles within the growing rim of the tumor but are too large to pass through the capillaries and into the venous system. Since yttrium-90 has a half-life of 64.1 hours, most of the radiation (94%) is delivered to the tumor over 11 days.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=93 Participants
Age, Categorical >=65 years	27 Participants n=93 Participants
Age, Continuous	66.4 years STANDARD_DEVIATION 6.6 • n=93 Participants
Sex: Female, Male Female	3 Participants n=93 Participants
Sex: Female, Male Male	27 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	11 Participants n=93 Participants
Race (NIH/OMB) White	17 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	30 participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Participants underwent standard of care and then underwent second mapping with low dose Y90 intervention.

Outcome measures

Outcome measures
Measure	Technetium-99m Macroaggregated Albumin (99mTc-MAA) n=30 Participants All patients will undergo standard of care mapping study with Technetium-99m macroaggregated albumin (99mTc-MAA) to plan for Y90 radioembolization therapy.	Second Mapping With Low-dose Y90 n=30 Participants Patients will undergo standard of care mapping study with 99TC-MAA to plan for Y90 radioembolization therapy. Additionally,non-standard of care, intervention will be to do a second mapping study using SIR-spheres microspheres with low-dose Y90 (15 mCi) before the therapeutic Y90 radioembolization. SIR-Spheres microspheres: SIR-Spheres® Y-90 resin microspheres consist of biocompatible polymer resin microspheres of a median diameter of 32.5 microns (range between 20 and 60 microns) loaded with yttrium-90 (beta radiation penetrating an average of 2.5 mm in tissue to destroy tumor cells). The resin microspheres are small enough to become lodged in the arterioles within the growing rim of the tumor but are too large to pass through the capillaries and into the venous system. Since yttrium-90 has a half-life of 64.1 hours, most of the radiation (94%) is delivered to the tumor over 11 days.
Lung Shunt Fraction (LSF) Ratio	5.68 Ratio Standard Deviation 3.12	5.79 Ratio Standard Deviation 2.08

PRIMARY outcome

Timeframe: Baseline

The ratios of the tumor-to-normal liver parenchymal radioactivity uptake count will be measured. TNR values will be calculated by dividing the mean count of the tumorous volume of interest (VOI) by the mean count of normal liver.

Outcome measures

Outcome measures
Measure	Technetium-99m Macroaggregated Albumin (99mTc-MAA) n=30 Participants All patients will undergo standard of care mapping study with Technetium-99m macroaggregated albumin (99mTc-MAA) to plan for Y90 radioembolization therapy.	Second Mapping With Low-dose Y90 n=30 Participants Patients will undergo standard of care mapping study with 99TC-MAA to plan for Y90 radioembolization therapy. Additionally,non-standard of care, intervention will be to do a second mapping study using SIR-spheres microspheres with low-dose Y90 (15 mCi) before the therapeutic Y90 radioembolization. SIR-Spheres microspheres: SIR-Spheres® Y-90 resin microspheres consist of biocompatible polymer resin microspheres of a median diameter of 32.5 microns (range between 20 and 60 microns) loaded with yttrium-90 (beta radiation penetrating an average of 2.5 mm in tissue to destroy tumor cells). The resin microspheres are small enough to become lodged in the arterioles within the growing rim of the tumor but are too large to pass through the capillaries and into the venous system. Since yttrium-90 has a half-life of 64.1 hours, most of the radiation (94%) is delivered to the tumor over 11 days.
Tumor to Normal Liver Activity Ratio (TNR)	2.67 Ratio Standard Deviation 1.67	2.75 Ratio Standard Deviation 1.2

SECONDARY outcome

Timeframe: 6 months post intervention

To identify tumor dose response threshold (TDRT) using Imaging Modified Response Criteria in Solid Tumors (m-RECIST), that is a method for measuring treatment response and measure of antitumor activity of cytotoxic drugs. This is measured using imaging: CT or MRI. The overall response is a combination of responses in each category: complete response (disappearance of any intramural arterial enhancement in all target lesions), partial response (at least 30% decrease in the sum of the diameters of viable target lesions), stable disease (any cases that do not qualify for either partial response or progressive disease) or progressive disease (an increase of at least 20% in the sum of the diameters of viable, enhancing target lesions, taking as a reference the smallest sum of the diameters of viable target lesions recorded since treatment started).

Outcome measures

Outcome measures
Measure	Technetium-99m Macroaggregated Albumin (99mTc-MAA) n=30 Participants All patients will undergo standard of care mapping study with Technetium-99m macroaggregated albumin (99mTc-MAA) to plan for Y90 radioembolization therapy.	Second Mapping With Low-dose Y90 Patients will undergo standard of care mapping study with 99TC-MAA to plan for Y90 radioembolization therapy. Additionally,non-standard of care, intervention will be to do a second mapping study using SIR-spheres microspheres with low-dose Y90 (15 mCi) before the therapeutic Y90 radioembolization. SIR-Spheres microspheres: SIR-Spheres® Y-90 resin microspheres consist of biocompatible polymer resin microspheres of a median diameter of 32.5 microns (range between 20 and 60 microns) loaded with yttrium-90 (beta radiation penetrating an average of 2.5 mm in tissue to destroy tumor cells). The resin microspheres are small enough to become lodged in the arterioles within the growing rim of the tumor but are too large to pass through the capillaries and into the venous system. Since yttrium-90 has a half-life of 64.1 hours, most of the radiation (94%) is delivered to the tumor over 11 days.
Number of Participants With Tumor Response Using Imaging Modified Response Criteria in Solid Tumors (m-RECIST) Post Y90 Embolization Complete tumor response	23 Count of participants	—
Number of Participants With Tumor Response Using Imaging Modified Response Criteria in Solid Tumors (m-RECIST) Post Y90 Embolization Partial tumor response	3 Count of participants	—
Number of Participants With Tumor Response Using Imaging Modified Response Criteria in Solid Tumors (m-RECIST) Post Y90 Embolization Stable disease	6 Count of participants	—
Number of Participants With Tumor Response Using Imaging Modified Response Criteria in Solid Tumors (m-RECIST) Post Y90 Embolization Progression of disease	0 Count of participants	—

Adverse Events

Technetium-99m Macroaggregated Albumin (99mTc-MAA)/Second Mapping With Low-dose Y90

Serious events: 1 serious events

Other events: 23 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Technetium-99m Macroaggregated Albumin (99mTc-MAA)/Second Mapping With Low-dose Y90 n=30 participants at risk Patients will undergo standard of care mapping study with 99TC-MAA to plan for Y90 radioembolization therapy. Additionally,non-standard of care, intervention will be to do a second mapping study using SIR-spheres microspheres with low-dose Y90 (15 mCi) before the therapeutic Y90 radioembolization. Additionally, non-standard of care, intervention will be to do a second mapping study using SIR-Spheres microspheres: SIR-Spheres® Y-90 resin microspheres consist of biocompatible polymer resin microspheres of a median diameter of 32.5 microns (range between 20 and 60 microns) loaded with yttrium-90 (beta radiation penetrating an average of 2.5 mm in tissue to destroy tumor cells). The resin microspheres are small enough to become lodged in the arterioles within the growing rim of the tumor but are too large to pass through the capillaries and into the venous system. Since yttrium-90 has a half-life of 64.1 hours, most of the radiation (94%) is delivered to the tumor over 11 days.
Hepatobiliary disorders Transplantation complication	3.3% 1/30 • Number of events 30 • 6 months All subjects underwent standard of care mapping study with 99TC-MAA to, immediately followed by a non-standard of care intervention: Second mapping study using SIR-spheres microspheres with low-dose Y90 for radioembolization. Both interventions were done on the same day and one immediately after the other. All data for adverse events was collected following all interventions, up to 6 months after the interventions, hence there is no distinction among arms for adverse events.

Other adverse events

Other adverse events
Measure	Technetium-99m Macroaggregated Albumin (99mTc-MAA)/Second Mapping With Low-dose Y90 n=30 participants at risk Patients will undergo standard of care mapping study with 99TC-MAA to plan for Y90 radioembolization therapy. Additionally,non-standard of care, intervention will be to do a second mapping study using SIR-spheres microspheres with low-dose Y90 (15 mCi) before the therapeutic Y90 radioembolization. Additionally, non-standard of care, intervention will be to do a second mapping study using SIR-Spheres microspheres: SIR-Spheres® Y-90 resin microspheres consist of biocompatible polymer resin microspheres of a median diameter of 32.5 microns (range between 20 and 60 microns) loaded with yttrium-90 (beta radiation penetrating an average of 2.5 mm in tissue to destroy tumor cells). The resin microspheres are small enough to become lodged in the arterioles within the growing rim of the tumor but are too large to pass through the capillaries and into the venous system. Since yttrium-90 has a half-life of 64.1 hours, most of the radiation (94%) is delivered to the tumor over 11 days.
Blood and lymphatic system disorders Decreased Albumin	6.7% 2/30 • Number of events 2 • 6 months All subjects underwent standard of care mapping study with 99TC-MAA to, immediately followed by a non-standard of care intervention: Second mapping study using SIR-spheres microspheres with low-dose Y90 for radioembolization. Both interventions were done on the same day and one immediately after the other. All data for adverse events was collected following all interventions, up to 6 months after the interventions, hence there is no distinction among arms for adverse events.
Blood and lymphatic system disorders Elevated Creatinine	6.7% 2/30 • Number of events 2 • 6 months All subjects underwent standard of care mapping study with 99TC-MAA to, immediately followed by a non-standard of care intervention: Second mapping study using SIR-spheres microspheres with low-dose Y90 for radioembolization. Both interventions were done on the same day and one immediately after the other. All data for adverse events was collected following all interventions, up to 6 months after the interventions, hence there is no distinction among arms for adverse events.
Blood and lymphatic system disorders Hyponatremia	3.3% 1/30 • Number of events 1 • 6 months All subjects underwent standard of care mapping study with 99TC-MAA to, immediately followed by a non-standard of care intervention: Second mapping study using SIR-spheres microspheres with low-dose Y90 for radioembolization. Both interventions were done on the same day and one immediately after the other. All data for adverse events was collected following all interventions, up to 6 months after the interventions, hence there is no distinction among arms for adverse events.
Blood and lymphatic system disorders Decreased WBC count	13.3% 4/30 • Number of events 4 • 6 months All subjects underwent standard of care mapping study with 99TC-MAA to, immediately followed by a non-standard of care intervention: Second mapping study using SIR-spheres microspheres with low-dose Y90 for radioembolization. Both interventions were done on the same day and one immediately after the other. All data for adverse events was collected following all interventions, up to 6 months after the interventions, hence there is no distinction among arms for adverse events.
General disorders Fatigue	13.3% 4/30 • Number of events 4 • 6 months All subjects underwent standard of care mapping study with 99TC-MAA to, immediately followed by a non-standard of care intervention: Second mapping study using SIR-spheres microspheres with low-dose Y90 for radioembolization. Both interventions were done on the same day and one immediately after the other. All data for adverse events was collected following all interventions, up to 6 months after the interventions, hence there is no distinction among arms for adverse events.
Gastrointestinal disorders Abdominal Pain	10.0% 3/30 • Number of events 3 • 6 months All subjects underwent standard of care mapping study with 99TC-MAA to, immediately followed by a non-standard of care intervention: Second mapping study using SIR-spheres microspheres with low-dose Y90 for radioembolization. Both interventions were done on the same day and one immediately after the other. All data for adverse events was collected following all interventions, up to 6 months after the interventions, hence there is no distinction among arms for adverse events.
Gastrointestinal disorders Ascites	10.0% 3/30 • Number of events 3 • 6 months All subjects underwent standard of care mapping study with 99TC-MAA to, immediately followed by a non-standard of care intervention: Second mapping study using SIR-spheres microspheres with low-dose Y90 for radioembolization. Both interventions were done on the same day and one immediately after the other. All data for adverse events was collected following all interventions, up to 6 months after the interventions, hence there is no distinction among arms for adverse events.
Nervous system disorders Encephalopathy	3.3% 1/30 • Number of events 1 • 6 months All subjects underwent standard of care mapping study with 99TC-MAA to, immediately followed by a non-standard of care intervention: Second mapping study using SIR-spheres microspheres with low-dose Y90 for radioembolization. Both interventions were done on the same day and one immediately after the other. All data for adverse events was collected following all interventions, up to 6 months after the interventions, hence there is no distinction among arms for adverse events.
Gastrointestinal disorders Nausea	13.3% 4/30 • Number of events 4 • 6 months All subjects underwent standard of care mapping study with 99TC-MAA to, immediately followed by a non-standard of care intervention: Second mapping study using SIR-spheres microspheres with low-dose Y90 for radioembolization. Both interventions were done on the same day and one immediately after the other. All data for adverse events was collected following all interventions, up to 6 months after the interventions, hence there is no distinction among arms for adverse events.
Gastrointestinal disorders Vomiting	13.3% 4/30 • Number of events 4 • 6 months All subjects underwent standard of care mapping study with 99TC-MAA to, immediately followed by a non-standard of care intervention: Second mapping study using SIR-spheres microspheres with low-dose Y90 for radioembolization. Both interventions were done on the same day and one immediately after the other. All data for adverse events was collected following all interventions, up to 6 months after the interventions, hence there is no distinction among arms for adverse events.
Blood and lymphatic system disorders Elevated Bilirubin	16.7% 5/30 • Number of events 5 • 6 months All subjects underwent standard of care mapping study with 99TC-MAA to, immediately followed by a non-standard of care intervention: Second mapping study using SIR-spheres microspheres with low-dose Y90 for radioembolization. Both interventions were done on the same day and one immediately after the other. All data for adverse events was collected following all interventions, up to 6 months after the interventions, hence there is no distinction among arms for adverse events.
Blood and lymphatic system disorders Elevated ALT	36.7% 11/30 • Number of events 11 • 6 months All subjects underwent standard of care mapping study with 99TC-MAA to, immediately followed by a non-standard of care intervention: Second mapping study using SIR-spheres microspheres with low-dose Y90 for radioembolization. Both interventions were done on the same day and one immediately after the other. All data for adverse events was collected following all interventions, up to 6 months after the interventions, hence there is no distinction among arms for adverse events.
Blood and lymphatic system disorders Elevated AST	36.7% 11/30 • Number of events 11 • 6 months All subjects underwent standard of care mapping study with 99TC-MAA to, immediately followed by a non-standard of care intervention: Second mapping study using SIR-spheres microspheres with low-dose Y90 for radioembolization. Both interventions were done on the same day and one immediately after the other. All data for adverse events was collected following all interventions, up to 6 months after the interventions, hence there is no distinction among arms for adverse events.
Blood and lymphatic system disorders Anemia	26.7% 8/30 • Number of events 8 • 6 months All subjects underwent standard of care mapping study with 99TC-MAA to, immediately followed by a non-standard of care intervention: Second mapping study using SIR-spheres microspheres with low-dose Y90 for radioembolization. Both interventions were done on the same day and one immediately after the other. All data for adverse events was collected following all interventions, up to 6 months after the interventions, hence there is no distinction among arms for adverse events.
Blood and lymphatic system disorders Altered platelet count	43.3% 13/30 • Number of events 13 • 6 months All subjects underwent standard of care mapping study with 99TC-MAA to, immediately followed by a non-standard of care intervention: Second mapping study using SIR-spheres microspheres with low-dose Y90 for radioembolization. Both interventions were done on the same day and one immediately after the other. All data for adverse events was collected following all interventions, up to 6 months after the interventions, hence there is no distinction among arms for adverse events.

Additional Information

Nima Kokabi, MD

Emory University

Phone: (404) 778-4747

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place