Carcinoma, Carcinoma, Hepatocellular, Liver Neoplasm
Conditions
Keywords
Technetium-99m macroaggregated-albumin (99mTc-MAA), SIR-Spheres Y90 resin microspheres treatment
Brief summary
The goal of this interventional clinical trial is to evaluate the dose of radiation of Technetium-99m macroaggregated-albumin (99mTc-MAA) after an intra-arterial injection to the whole body and non-liver critical organs in patients who are undergoing evaluation for SIR-Spheres treatment for hepatocellular carcinoma.
Detailed description
The investigation is a prospective, single center, open label, single-arm study. Patients enrolled in the study will have 3 imaging scans taken after 99mTc-MAA injection, the final of which will occur between 18 and 24 hours post-injection.
Interventions
DRUG99mTc-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.
Sponsors
Bright Research Partners
Sirtex Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Willing, able, and mentally competent to provide written informed consent 2. Age 18 or older at the time of consent 3. Patients who are being evaluated for SIR-Spheres treatment eligibility
Exclusion criteria
1. Patients who are contraindicated for SIR-Spheres treatment 2. Patients who are contraindicated for 99mTc-MAA per the manufacturer's package insert
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective Dose (Gy) for the Whole Body | 18-24 hours |
| Mean Absorbed Dose (Gy) for the Whole Body | 18-24 hours |
| Mean Absorbed Dose (Gy) for Critical Non-liver Organs | 18-24 hours |
| Mean Activity (Bq) for the Whole Body | 18-24 hours |
| Mean Activity (Bq) for Critical Non-liver Organs | 18-24 hours |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 99mTc-MAA Injection 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. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | 99mTc-MAA Injection |
|---|---|
| Age, Continuous | 62.2 years STANDARD_DEVIATION 14 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Effective Dose (Gy) for the Whole Body
Time frame: 18-24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 99mTc-MAA Injection | Effective Dose (Gy) for the Whole Body | 0.6 mGy | Standard Deviation 0.6 |
Primary
Mean Absorbed Dose (Gy) for Critical Non-liver Organs
Time frame: 18-24 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 99mTc-MAA Injection | Mean Absorbed Dose (Gy) for Critical Non-liver Organs | Adrenal glands | 1.415 mGy | Standard Deviation 1.524 |
| 99mTc-MAA Injection | Mean Absorbed Dose (Gy) for Critical Non-liver Organs | Gallbladder | 4.855 mGy | Standard Deviation 5.444 |
| 99mTc-MAA Injection | Mean Absorbed Dose (Gy) for Critical Non-liver Organs | Heart | 0.736 mGy | Standard Deviation 0.692 |
| 99mTc-MAA Injection | Mean Absorbed Dose (Gy) for Critical Non-liver Organs | Kidney | 2.073 mGy | Standard Deviation 3.401 |
| 99mTc-MAA Injection | Mean Absorbed Dose (Gy) for Critical Non-liver Organs | Lungs | 1.701 mGy | Standard Deviation 1.869 |
| 99mTc-MAA Injection | Mean Absorbed Dose (Gy) for Critical Non-liver Organs | Pancreas | 1.221 mGy | Standard Deviation 0.99 |
| 99mTc-MAA Injection | Mean Absorbed Dose (Gy) for Critical Non-liver Organs | Spleen | 0.784 mGy | Standard Deviation 1.037 |
| 99mTc-MAA Injection | Mean Absorbed Dose (Gy) for Critical Non-liver Organs | Stomach | 2.530 mGy | Standard Deviation 2.634 |
| 99mTc-MAA Injection | Mean Absorbed Dose (Gy) for Critical Non-liver Organs | Upper bowel | 0.809 mGy | Standard Deviation 0.785 |
Primary
Mean Absorbed Dose (Gy) for the Whole Body
Time frame: 18-24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 99mTc-MAA Injection | Mean Absorbed Dose (Gy) for the Whole Body | 0.941 mGy | Standard Deviation 0.926 |
Primary
Mean Activity (Bq) for Critical Non-liver Organs
Time frame: 18-24 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 99mTc-MAA Injection | Mean Activity (Bq) for Critical Non-liver Organs | Adrenal glands | 0.150 GBq | Standard Deviation 0.014 |
| 99mTc-MAA Injection | Mean Activity (Bq) for Critical Non-liver Organs | Gallbladder | 0.148 GBq | Standard Deviation 0.016 |
| 99mTc-MAA Injection | Mean Activity (Bq) for Critical Non-liver Organs | Heart | 0.150 GBq | Standard Deviation 0.014 |
| 99mTc-MAA Injection | Mean Activity (Bq) for Critical Non-liver Organs | Kidney | 0.150 GBq | Standard Deviation 0.014 |
| 99mTc-MAA Injection | Mean Activity (Bq) for Critical Non-liver Organs | Lungs | 0.150 GBq | Standard Deviation 0.014 |
| 99mTc-MAA Injection | Mean Activity (Bq) for Critical Non-liver Organs | Pancreas | 0.150 GBq | Standard Deviation 0.014 |
| 99mTc-MAA Injection | Mean Activity (Bq) for Critical Non-liver Organs | Spleen | 0.145 GBq | Standard Deviation 0.018 |
| 99mTc-MAA Injection | Mean Activity (Bq) for Critical Non-liver Organs | Stomach | 0.150 GBq | Standard Deviation 0.014 |
| 99mTc-MAA Injection | Mean Activity (Bq) for Critical Non-liver Organs | Upper bowel | 0.150 GBq | Standard Deviation 0.014 |
Primary
Mean Activity (Bq) for the Whole Body
Time frame: 18-24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 99mTc-MAA Injection | Mean Activity (Bq) for the Whole Body | 0.150 GBq | Standard Deviation 0.014 |