Clinical trial · Interventional
Demonstration of the "SPECT/CT System With CZT Detectors" Imaging Performance in a Clinical Setting
NCT03229772CI-TRIAL-00028781completedN/AClinicalTrials.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)
The primary purpose of the study is to obtain sample clinical images that are evaluated by physicians in support of regulatory submissions. Additionally, the study will provide data for current and future product development and it will provide clinical images and data for marketing use.
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 | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Discovery NM/CT 670 CZT Imaging Scan | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Subjects indicated for dynamic nuclear medicine scanning
- description
- The trial will consist of a single arm composed of subjects with preexisting indications for dynamic nuclear medicine scanning at the site. All patients will undergo nuclear medicine scintigraphy using the GE Discovery 670 NM/CT device with and without CZT enabled during a single visit.
- interventionNames
- Device: Discovery NM/CT 670 CZT Imaging Scan
Primary outcomes (2)
- measure
- Diagnostic Image Quality
- timeFrame
- 12 weeks
- description
- Diagnostic Image Quality will be rated by 2 radiologist using a 5 point Likert Scale
- measure
- Image Resolution
- timeFrame
- 12 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: 1. are 18-years old and older; 2. is able to sign and date the informed consent form; AND 3. have been prescribed by a physician a nuclear medicine exam that is within the intended use of the device. Exclusion Criteria: 1. Patients who were referred for dynamic nuclear medicine scan because of the need to be injected twice (once for the conventional acquisition and once for the investigational device) that would result in an increase dose burden on patient. 2. Pregnant or lactating women 3. Who were previously enrolled in this study; 4. Who have contraindication for the radiopharmaceutical 5. Who have any conditions that, in the opinion of the Investigator, would interfere with the evaluation of the results or constitute a health hazard for the subject;
References
Publications (0)
Data not yet available
No reference posted for this study.