Dose Response Relationship, Drug
Conditions
Keywords
injections, intravenous, fluorodeoxyglucose F-18
Brief summary
A widely used semi-quantitative parameter to assess tumor status is the standardized uptake value (SUV). SUV estimation accuracy can be impacted by many variables. Today there still exists a significant amount of variability in PET/CT results in test and re-test studies. This variability can be introduced by instrumentation and subject-specific factors. Variability reduces image quality and increases the required changes in tumor quantification to reflect real tumor response or progression. PET/CT scanning process requires that the entire net injected dose of radiolabeled tracer is administered intravenously as a bolus. The quality and quantification of a PET/CT image is highly dependent on the uptake of radiolabeled tracer. Boellaard et al. have indicated infiltrations could potentially underestimate SUV measurements by as much as 50%. Infiltrations and obstructions are not uncommon. Recent studies using a novel QA/QC tool (LaraTM System) for the radiotracer injection process revealed that current means to detect infiltration do not completely identify all infiltrations/obstructions. Since infiltrations may not be visible in the standard field of view (FOV) and since the impact of a peripheral circulatory obstruction may not be visible even if an injection site is in the FOV, it is possible for reading and treating physicians to be unaware that a patient's image and quantification has been impacted. Additionally, when current means do detect an infiltration, they under-represent the severity because they are not capturing that infiltrations often resolve during the uptake period. As a result, infiltrations or obstructions may cause SUV inaccuracy and could adversely impact staging and tumor assessments. The purpose of this study will be to characterize the impact of moderate or greater infiltrations on standardized uptake values. Patients experiencing a moderate or greater infiltration on a routine clinical PET scan will be invited to return for a repeat scan with injection performed by specially trained personnel to reduce the risk of repeat infiltration. The two scans will be compared to assess for changes in tumor uptake intensity.
Interventions
DIAGNOSTIC_TESTF-18 FDG PET
Repeat scan performed by specially trained staff to reduce risk of repeat infiltration.
Sponsors
Lucerno Dynamics, LLC
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Reader will not be informed which scan was infiltrated.
Intervention model description
All patients with a moderate or greater infiltration on a routine F-18 FDG PET will be invited to return for a repeat scan.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with solid tumors undergoing PET/CT scan who have at least one measurable target lesion and sustain a moderate or greater infiltration.
Exclusion criteria
* Subjects unwilling or unable to tolerate a repeat PET/CT scan. * Subjects with meaningful medical intervention between PET/CT scans that would likely impact SUV. * Subjects with follow up injection infiltrations that would likely impact the SUV. * Pregnant patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in SUVpeak of Target Lesions Between Infiltrated and Non-infiltrated Scans | Baseline scan and follow up scan within 7 days | Target lesions selected as per PERCIST criteria. These criteria require more space than allowed to explain. Reference J Nucl Med 2009; 50: 122S-150S. DOI: 10.2967/jnumed.108.057307 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Metabolic Tumor Volume of Target Lesions Between Infiltrated and Non-infiltrated Scans | 7 days | Metabolic tumor volume to be measured using threshold defined in PERCIST criteria |
| Change in Total Lesion Glycolysis of Target Lesions Between Infiltrated and Non-infiltrated Scans | 7 days | Total lesion glycolysis is calculated for the same metabolic tumor volume as Outcome 2 |
| Change in Estimated Tumor Stage or Predicted Response to Therapy Between Infiltrated and Non-infiltrated Scans | 7 days | Response is defined per PERCIST criteria |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Infiltration Repeat F-18 FDG PET
F-18 FDG PET: Repeat scan performed by specially trained staff to reduce risk of repeat infiltration. | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Infiltration | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 1 Participants | — |
| Age, Categorical Between 18 and 65 years | 0 Participants | — |
| Initial Lara TAC score | 1104 units on a scale | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 1 participants | — |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 1 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 1 / 1 |
Outcome results
Primary
Change in SUVpeak of Target Lesions Between Infiltrated and Non-infiltrated Scans
Target lesions selected as per PERCIST criteria. These criteria require more space than allowed to explain. Reference J Nucl Med 2009; 50: 122S-150S. DOI: 10.2967/jnumed.108.057307
Time frame: Baseline scan and follow up scan within 7 days
Population: Up to 5 target lesions measured per participant (4 for this subject) with mean and standard deviation reported below.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Infiltration | Change in SUVpeak of Target Lesions Between Infiltrated and Non-infiltrated Scans | 3.6 SUV (dimensionless) | Standard Deviation 1.4 |
Other Pre-specified
Change in Estimated Tumor Stage or Predicted Response to Therapy Between Infiltrated and Non-infiltrated Scans
Response is defined per PERCIST criteria
Time frame: 7 days
Other Pre-specified
Change in Metabolic Tumor Volume of Target Lesions Between Infiltrated and Non-infiltrated Scans
Metabolic tumor volume to be measured using threshold defined in PERCIST criteria
Time frame: 7 days
Other Pre-specified
Change in Total Lesion Glycolysis of Target Lesions Between Infiltrated and Non-infiltrated Scans
Total lesion glycolysis is calculated for the same metabolic tumor volume as Outcome 2
Time frame: 7 days