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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA195513 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Ohio Third Frontier | OTHER |
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The purpose of this study is to assess new low radiation dose techniques for clinical PET/CT scans through intra-individual comparison between a clinical, standard dose scan and a low-dose scan, completed within one week of each other.
Positron Emission Tomography/Computed Tomography (PET/CT) imaging using 18F-FDG is an important, commonly used cancer, neuroscience and cardio-vascular imaging methodology to detect disease and to monitor therapeutic interventions. While considerable technological progress of PET/CT systems has occurred over the last decade, we have not re-evaluated the ability to potentially reduce the radiation burden of the used PET imaging pharmaceutical (FDG).
This early phase trial intends to accomplish the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sub-Study A | Experimental | Patients receive PET/CT scan on Gemini Astonish PET/CT |
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| Sub-Study B | Experimental | Patients receive PET/CT scan on Biograph mCT |
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| Sub-Study C | Experimental | Patients receive PET/CT scan on Discovery PET/CT |
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| Sub-Study D | Experimental | Patients receive PET/CT scan on Vereos 128 digital PET/CT |
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| Sub-Study E | Experimental | Patients receive lower radiation dose on Vereos 128 digital PET/CT |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET/CT scan with 13 mCi radiation dose | Diagnostic Test | 13 mCi 18F-FDG dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Image quality | assessed by blinded readers | through study completion, on average 2-5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Artifacts | assessed by blinded readers | through study completion, on average 2-5 years |
| Lesion detectability | assessed by blinded readers |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael V Knopp, MD, PhD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43221 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 22, 2017 | Feb 22, 2018 |
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| Sub-Study F | Experimental | Patients receive PET/SCAN using system that did not show equivalence in Sub-Study A-C |
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| PET/CT scan with 5 mCi radiation dose | Diagnostic Test | 5 mCi 18F-FDG dose |
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| PET/CT scan with 2.5 mCi radiation dose | Diagnostic Test | 2.5 mCi 18F-FDG dose |
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| PET/CT Scan with 6.5 mCi radiation dose | Diagnostic Test | 6.5 mCi 18F-FDG dose |
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| PET/CT Scan with not yet determined radiation dose | Diagnostic Test | We plan for the possibility that one of the three-Sub-Studies (A-B) would not demonstrate equivalency, and we would then perform a modified protocol in which the SOC dosing is compared to a lower and higher dose than originally tested. |
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| through study completion, on average 2-5 years |
| Image noise | assessed by blinded readers | through study completion, on average 2-5 years |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D000072078 | Positron Emission Tomography Computed Tomography |
| ID | Term |
|---|---|
| D049268 | Positron-Emission Tomography |
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014057 | Tomography, X-Ray Computed |
| D064847 | Multimodal Imaging |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |
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