Cancer
Conditions
Keywords
PET/CT, digital PET/CT
Brief summary
The investigators wish to determine if standard and digital PET/CT scanners provide equivalent results for disease detection and diagnosis.
Detailed description
There will be a single injection of the PET radiopharmaceutical followed by a standard PET/CT scan and immediately after by the digital PET/CT scan, or vice versa. The investigators wish to determine if image quality is equivalent with the digital PET/CT scanner.
Interventions
DIAGNOSTIC_TESTDigital PET/CT scan
The Division of Nuclear Medicine and Molecular Imaging at Stanford has installed the first ever GE-made digital PET/CT scanner worldwide. The investigators wish to determine if the digital PET/CT scanner offers equivalent image quality as the standard PET/CT scanner.
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 is ≥ 18 years old at the time of the scan * Patient provides written informed consent * Patient is referred for standard (F18 FDG; F18 NaF; Ga68 DOTATATE) or research (68Ga PSMA or 68Ga RM2) PET/CT * Patient is capable of complying with study procedures * Patient is able to remain still for duration of imaging procedure (approximately 60 minutes total for both PET/CT)
Exclusion criteria
* Patient is pregnant or nursing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Image Quality | an expected average of 3 hours | Diagnostic image quality will be determined using a 5-point Likert Scale that reads: 5 - Diagnostic: Excellent diagnostic image quality; 4 - Diagnostic: Good diagnostic image quality; 3 - Diagnostic: Acceptable diagnostic image quality; 2 - Sub-optimal diagnostic: image quality with limited additional clinical information; 1 - Non-diagnostic: non-diagnostic image quality |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients Undergoing Digital PET/CT Patients referred to Nuclear Medicine undergo imaging on the standard PET/CT and also have imaging performed on the digital PET/CT. | 199 |
| Total | 199 |
Baseline characteristics
| Characteristic | Patients Undergoing Digital PET/CT |
|---|---|
| Age, Continuous | 64.8 years STANDARD_DEVIATION 10.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 176 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 20 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 17 Participants |
| Race (NIH/OMB) White | 159 Participants |
| Region of Enrollment United States | 199 Participants |
| Sex: Female, Male Female | 55 Participants |
| Sex: Female, Male Male | 144 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 199 | 0 / 199 |
| other Total, other adverse events | 0 / 199 | 0 / 199 |
| serious Total, serious adverse events | 0 / 199 | 0 / 199 |
Outcome results
Primary
Diagnostic Image Quality
Diagnostic image quality will be determined using a 5-point Likert Scale that reads: 5 - Diagnostic: Excellent diagnostic image quality; 4 - Diagnostic: Good diagnostic image quality; 3 - Diagnostic: Acceptable diagnostic image quality; 2 - Sub-optimal diagnostic: image quality with limited additional clinical information; 1 - Non-diagnostic: non-diagnostic image quality
Time frame: an expected average of 3 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Digital PET/CT | Diagnostic Image Quality | 4.96 score on a scale | Standard Deviation 0.2 |
| Standard PET/CT | Diagnostic Image Quality | 4.30 score on a scale | Standard Deviation 0.47 |
p-value: <1e-7t-test, 2 sided