Pilot Breast-Dedicated PET Camera With 1 Millimeter Spatial Resolution
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|ClinicalTrials.gov Identifier: NCT04016818|
Recruitment Status : Not yet recruiting
First Posted : July 12, 2019
Last Update Posted : July 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: 18F-FDG Device: Breast-dedicated PET camera||Early Phase 1|
Primary Objective To obtain initial experience using the novel, breast-dedicated PET camera design in the breast imaging clinic.
Secondary Objectives To understand, given the 10-fold higher sensitivity of this novel camera, how low we can go with administered tracer dose, and, given the >100-fold better volumetric spatial resolution, understand the achievable image quality.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Pilot Study of a Breast-Dedicated PET Camera With 1 Millimeter Spatial Resolution|
|Estimated Study Start Date :||December 2019|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: 18-F FDG Study using Breast-Dedicated PET Camera
Breast-Dedicated PET Camera will be used with standard PET 18-F FDG tracer dose
Participant will be injected IV (intravenously) with 10 ± 2 mCi of 18F-FDG.
Device: Breast-dedicated PET camera
Breast-dedicated PET camera designed by Stanford satellite radiochemistry facility
- Image quality with the breast-dedicated PET camera [ Time Frame: 1 day ]Feasibility of the pilot breast-dedicated PET camera will be assessed on the basis of whether acceptable images are obtained. Images will be assessed and graded as 1 of 3 quality ratings: excellent, good, and poor. The outcome will be reported as the number of images that are excellent, good, and poor, a number without dispersion.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04016818
|Contact: Risa Jironfirstname.lastname@example.org|
|United States, California|
|Stanford University||Not yet recruiting|
|Stanford, California, United States, 94304|
|Contact: Risa Jiron 650-736-1598 email@example.com|
|Principal Investigator:||Wendy B DeMartini||Stanford University|