Trial Outcomes & Findings for SIR-Spheres Study to Calculate the Radiation-Absorbed Dose of 99mTc-MAA (NCT NCT05848947)
NCT ID: NCT05848947
Last Updated: 2025-01-29
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
5 participants
Primary outcome timeframe
18-24 hours
Results posted on
2025-01-29
Participant Flow
Participant milestones
| Measure |
99mTc-MAA Injection
Patients enrolled in the study had 3 imaging scans taken after 99mTc-MAA Injection with the final scan occurring 18-24 hours after injection.
99mTc-Macro Albumin Aggregate: Technetium-99m macroaggregated-albumin consists of macroaggregated-albumin particles labeled with technetium-99m (99mTc), with a size between 10 and 90 microns in diameter. 99mTc is a gamma emitting radioactive isotope commonly used for diagnostic localization studies.
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|---|---|
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Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SIR-Spheres Study to Calculate the Radiation-Absorbed Dose of 99mTc-MAA
Baseline characteristics by cohort
| Measure |
99mTc-MAA Injection
n=5 Participants
Patients enrolled in the study will have 3 imaging scans taken after 99mTc-MAA Injection with the final scan occurring 18-24 hours after injection.
99mTc-Macro Albumin Aggregate: Technetium-99m macroaggregated-albumin consists of macroaggregated-albumin particles labeled with technetium-99m (99mTc), with a size between 10 and 90 microns in diameter. 99mTc is a gamma emitting radioactive isotope commonly used for diagnostic localization studies.
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|---|---|
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Age, Continuous
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62.2 years
STANDARD_DEVIATION 14.0 • n=5 Participants
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Sex: Female, Male
Female
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2 Participants
n=5 Participants
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|
Sex: Female, Male
Male
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3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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|
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
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18-24 hoursOutcome measures
| Measure |
99mTc-MAA Injection
n=5 Participants
Patients enrolled in the study had 3 imaging scans taken after 99mTc-MAA Injection with the final scan occurring 18-24 hours after injection.
99mTc-Macro Albumin Aggregate: Technetium-99m macroaggregated-albumin consists of macroaggregated-albumin particles labeled with technetium-99m (99mTc), with a size between 10 and 90 microns in diameter. 99mTc is a gamma emitting radioactive isotope commonly used for diagnostic localization studies.
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|---|---|
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Mean Absorbed Dose (Gy) for the Whole Body
|
0.941 mGy
Standard Deviation 0.926
|
PRIMARY outcome
Timeframe: 18-24 hoursOutcome measures
| Measure |
99mTc-MAA Injection
n=5 Participants
Patients enrolled in the study had 3 imaging scans taken after 99mTc-MAA Injection with the final scan occurring 18-24 hours after injection.
99mTc-Macro Albumin Aggregate: Technetium-99m macroaggregated-albumin consists of macroaggregated-albumin particles labeled with technetium-99m (99mTc), with a size between 10 and 90 microns in diameter. 99mTc is a gamma emitting radioactive isotope commonly used for diagnostic localization studies.
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|---|---|
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Mean Absorbed Dose (Gy) for Critical Non-liver Organs
Adrenal glands
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1.415 mGy
Standard Deviation 1.524
|
|
Mean Absorbed Dose (Gy) for Critical Non-liver Organs
Gallbladder
|
4.855 mGy
Standard Deviation 5.444
|
|
Mean Absorbed Dose (Gy) for Critical Non-liver Organs
Heart
|
0.736 mGy
Standard Deviation 0.692
|
|
Mean Absorbed Dose (Gy) for Critical Non-liver Organs
Kidney
|
2.073 mGy
Standard Deviation 3.401
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|
Mean Absorbed Dose (Gy) for Critical Non-liver Organs
Lungs
|
1.701 mGy
Standard Deviation 1.869
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|
Mean Absorbed Dose (Gy) for Critical Non-liver Organs
Pancreas
|
1.221 mGy
Standard Deviation 0.990
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Mean Absorbed Dose (Gy) for Critical Non-liver Organs
Spleen
|
0.784 mGy
Standard Deviation 1.037
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|
Mean Absorbed Dose (Gy) for Critical Non-liver Organs
Stomach
|
2.530 mGy
Standard Deviation 2.634
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Mean Absorbed Dose (Gy) for Critical Non-liver Organs
Upper bowel
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0.809 mGy
Standard Deviation 0.785
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PRIMARY outcome
Timeframe: 18-24 hoursOutcome measures
| Measure |
99mTc-MAA Injection
n=5 Participants
Patients enrolled in the study had 3 imaging scans taken after 99mTc-MAA Injection with the final scan occurring 18-24 hours after injection.
99mTc-Macro Albumin Aggregate: Technetium-99m macroaggregated-albumin consists of macroaggregated-albumin particles labeled with technetium-99m (99mTc), with a size between 10 and 90 microns in diameter. 99mTc is a gamma emitting radioactive isotope commonly used for diagnostic localization studies.
|
|---|---|
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Mean Activity (Bq) for the Whole Body
|
0.150 GBq
Standard Deviation 0.014
|
PRIMARY outcome
Timeframe: 18-24 hoursOutcome measures
| Measure |
99mTc-MAA Injection
n=5 Participants
Patients enrolled in the study had 3 imaging scans taken after 99mTc-MAA Injection with the final scan occurring 18-24 hours after injection.
99mTc-Macro Albumin Aggregate: Technetium-99m macroaggregated-albumin consists of macroaggregated-albumin particles labeled with technetium-99m (99mTc), with a size between 10 and 90 microns in diameter. 99mTc is a gamma emitting radioactive isotope commonly used for diagnostic localization studies.
|
|---|---|
|
Mean Activity (Bq) for Critical Non-liver Organs
Kidney
|
0.150 GBq
Standard Deviation 0.014
|
|
Mean Activity (Bq) for Critical Non-liver Organs
Lungs
|
0.150 GBq
Standard Deviation 0.014
|
|
Mean Activity (Bq) for Critical Non-liver Organs
Pancreas
|
0.150 GBq
Standard Deviation 0.014
|
|
Mean Activity (Bq) for Critical Non-liver Organs
Spleen
|
0.145 GBq
Standard Deviation 0.018
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Mean Activity (Bq) for Critical Non-liver Organs
Stomach
|
0.150 GBq
Standard Deviation 0.014
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Mean Activity (Bq) for Critical Non-liver Organs
Upper bowel
|
0.150 GBq
Standard Deviation 0.014
|
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Mean Activity (Bq) for Critical Non-liver Organs
Adrenal glands
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0.150 GBq
Standard Deviation 0.014
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Mean Activity (Bq) for Critical Non-liver Organs
Gallbladder
|
0.148 GBq
Standard Deviation 0.016
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Mean Activity (Bq) for Critical Non-liver Organs
Heart
|
0.150 GBq
Standard Deviation 0.014
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PRIMARY outcome
Timeframe: 18-24 hoursOutcome measures
| Measure |
99mTc-MAA Injection
n=5 Participants
Patients enrolled in the study had 3 imaging scans taken after 99mTc-MAA Injection with the final scan occurring 18-24 hours after injection.
99mTc-Macro Albumin Aggregate: Technetium-99m macroaggregated-albumin consists of macroaggregated-albumin particles labeled with technetium-99m (99mTc), with a size between 10 and 90 microns in diameter. 99mTc is a gamma emitting radioactive isotope commonly used for diagnostic localization studies.
|
|---|---|
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Effective Dose (Gy) for the Whole Body
|
0.6 mGy
Standard Deviation 0.6
|
Adverse Events
99mTc-MAA Injection
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
Janet Bell, Director, Clinical Research Operations
Sirtex Medical
Phone: 978-866-1798
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Upon completion of the Study, Institution and Investigator may publish or present the Study Data subject to the following terms: a copy of any proposed publication or disclosure of the results of the Study will be given to the Sponsor for review at least thirty (30) days prior to the date of submission for publication (including abstracts) or of public disclosure.
- Publication restrictions are in place
Restriction type: OTHER