Primary Malignant Liver Neoplasm
Conditions
Brief summary
This clinical trial studies how well yttrium-90 (Y90) glass microspheres positron emission tomography (PET)/computed tomography (CT) works in imaging patients with liver tumors . Images produced by PET/CT may provide better information about the distribution of particles, such as Y90 glass microspheres, delivered for selective internal radiation therapy (SIRT) as compared to regular medical care images useing technetium Tc-99m albumin-aggregated single photon emission computed tomography (SPECT)/CT images.
Detailed description
PRIMARY OBJECTIVES: I. To evaluate the image quality of yttrium-90 (Y90) microspheres PET/CT post SIRT images as compared to technetium Tc-99m albumin aggregated (99mTc MAA) SPECT/CT. SECONDARY OBJECTIVES: I. To determine the superior accuracy in both distribution and dosimetry of Y90 PET/CT post-SIRT imaging compared to 99mTc MAA planar and SPECT/CT imaging. OUTLINE: Immediately after standard of care SIRT, patients receive Y90 glass microspheres and undergo PET/CT over 30 minutes. This study compares the experimental images to the regular medical care images in the same participant.
Interventions
PROCEDUREComputed Tomography (CT)
As part of PET/CT and SPECT/CT scans.
PROCEDUREPositron Emission Tomography (PET)
As part of PET/CT scan
DEVICE90-Yttrium (Y-90) Glass Microspheres
Radiolabel for PET/CT scan
DIAGNOSTIC_TESTTechnetium 99mTc albumin aggregated (99mTc-MAA)
Radiolabel for 99mTc-MAA SPECT/CT Scan
PROCEDURESingle-photon emission computerized tomography (SPECT) scan
As part of SPECT/CT scan
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient provides written informed consent * Patient is referred for 90Y SIRT radioembolization of liver tumor(s) * Patient is capable of complying with study procedures * Patient is able to remain still for duration of imaging procedure (approximately 30 minutes total for digital PET/CT)
Exclusion criteria
* Patient is pregnant or nursing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Image Quality for 90-Y PET/CT Scans | 1 day | Image quality for 90Y PET/CT scan images was assessed relative to the expected image quality of Standard of Care (SoC) 99mTc-MAA SPECT/CT scans obtained from the same participant. Assessments were conducted at 5, 10, 15 and 20 minutes after infusion. Scans were assessed on a 1 to 5 Likert scale by 2 Nuclear Medicine physicians who were blinded to patient information. The Likert scale for image quality was established as follows: 1. = Non-diagnostic 2. = Suboptimal 3. = Acceptable 4. = Good 5. = Excellent, equivalent to a SoC 99mTc-MAA SPECT/CT scan The scans for each individual participant at each timepoint was scored on the Likert scale, as determined by the 2 Nuclear Medicine physicians. The outcome is reported as the overall mean of the physician determinations for each time point, with standard deviation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiopharmaceutical Dosimetry Accuracy for 90-Y PET/CT Scans and 99mTc-MAA SPECT/CT Scans | 1 day | Radiopharmaceutical dosimetry was assessed based on the numerical tumor-absorbed dose value in Gray as calculated by SurePlan (MIM Software Inc, Cleveland, Ohio). The outcome is reported as the median tumor-absorbed dose in Gray for each scan method (90Y PET/CT and 99mTc-MAA SPECT/CT), with standard deviation. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans All participants receive both Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans
* Computed Tomography (CT): As part of PET/CT and SPECT/CT scans.
* Positron Emission Tomography (PET): As part of PET/CT scan
* Single-photon emission computerized tomography (SPECT) scan: As part of SPECT/CT scan
* 90-Yttrium (Y-90) Glass Microspheres: Radiolabel for PET/CT scan
* Technetium 99mTc albumin aggregated (99mTc-MAA): Radiolabel for 99mTc-MAA SPECT/CT Scan | 42 |
| Total | 42 |
Baseline characteristics
| Characteristic | Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 26 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Age, Continuous | 67.1 years STANDARD_DEVIATION 11.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 13 Participants |
| Race (NIH/OMB) Black or African American | 2 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 | 4 Participants |
| Race (NIH/OMB) White | 22 Participants |
| Region of Enrollment United States | 42 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 42 |
| other Total, other adverse events | 0 / 42 |
| serious Total, serious adverse events | 0 / 42 |
Outcome results
Primary
Image Quality for 90-Y PET/CT Scans
Image quality for 90Y PET/CT scan images was assessed relative to the expected image quality of Standard of Care (SoC) 99mTc-MAA SPECT/CT scans obtained from the same participant. Assessments were conducted at 5, 10, 15 and 20 minutes after infusion. Scans were assessed on a 1 to 5 Likert scale by 2 Nuclear Medicine physicians who were blinded to patient information. The Likert scale for image quality was established as follows: 1. = Non-diagnostic 2. = Suboptimal 3. = Acceptable 4. = Good 5. = Excellent, equivalent to a SoC 99mTc-MAA SPECT/CT scan The scans for each individual participant at each timepoint was scored on the Likert scale, as determined by the 2 Nuclear Medicine physicians. The outcome is reported as the overall mean of the physician determinations for each time point, with standard deviation.
Time frame: 1 day
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans | Image Quality for 90-Y PET/CT Scans | 5 minutes | 3.56 units on a scale | Standard Deviation 0.43 |
| Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans | Image Quality for 90-Y PET/CT Scans | 10 minutes | 4.63 units on a scale | Standard Deviation 0.49 |
| Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans | Image Quality for 90-Y PET/CT Scans | 15 minutes | 4.89 units on a scale | Standard Deviation 0.28 |
| Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans | Image Quality for 90-Y PET/CT Scans | 20 minutes | 4.93 units on a scale | Standard Deviation 0.21 |
Secondary
Radiopharmaceutical Dosimetry Accuracy for 90-Y PET/CT Scans and 99mTc-MAA SPECT/CT Scans
Radiopharmaceutical dosimetry was assessed based on the numerical tumor-absorbed dose value in Gray as calculated by SurePlan (MIM Software Inc, Cleveland, Ohio). The outcome is reported as the median tumor-absorbed dose in Gray for each scan method (90Y PET/CT and 99mTc-MAA SPECT/CT), with standard deviation.
Time frame: 1 day
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans | Radiopharmaceutical Dosimetry Accuracy for 90-Y PET/CT Scans and 99mTc-MAA SPECT/CT Scans | 142.9 Gray | Standard Error 99.7 |
| 99mTc-MAA SPECT/CT Scans | Radiopharmaceutical Dosimetry Accuracy for 90-Y PET/CT Scans and 99mTc-MAA SPECT/CT Scans | 118.9 Gray | Standard Error 91 |