Clinical trial · Observational
Verification of Imaging System PCD-1000A
NCT04024748CI-TRIAL-00053148completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Scope Verification of technologies included in the PCD-1000A PET/CT imaging chain. * Define and confirm all supported clinical protocols * Evaluate performance
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Patients | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PET/CT imaging | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients already scheduled for a FDG test
- description
- Subjects will be selected from patients already scheduled for a routine FDG PET/CT test. Only adult patients, 40 years old or older, capable of providing their informed consent, will be selected. Any adult female patients that are pregnant and/or could become pregnant will be excluded. Twenty patients will be recruited.
- interventionNames
- Device: PET/CT imaging
Primary outcomes (1)
- measure
- Confirm that PCD-1000A PET/CT System is Effective for Its Intended Use
- timeFrame
- 3 months
- description
- PCD-1000A PET/CT system's performance will be evaluated for oncology PET imaging on cancer patients to verify that the system performs as expected. • Verify that all supported clinical protocols from PET acquisition, reconstruction, to presentation (filtering) perform as expected. Images acquired by PCD-1000A PET/CT will be compared with images acquired during a standard-of-care PET/CT scan by a commercially available PET/CT system just prior to imaging with the PCD-1000A PET/CT System. Image quality evaluation will include assessment of uniformity of the liver, delineation of the lungs, presence of artifacts and using Likert scale.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Patients already scheduled for an FDG test at SDMI * 40 years and older * Capable of providing their informed consent Exclusion Criteria: * Patients not scheduled for an FDG test at SDMI * 39 years or younger * Adult female patients that are and/or could become pregnant * Not capable of providing their informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.