Breast Lesions Clinical Trial
Official title:
A Pilot, Single Centre, Prospective Clinical Study Investigation of the Acceptability of a Dedicated High Resolution Nuclear Breast Imaging Camera (MBI) in Breast Imaging of Patients Administered Tc-99m Sestamibi (ROSE)
This research protocol is designed to evaluate a novel imaging camera, only one of three of
it's kind in existence, in the diagnosis of breast cancer. The Molecular Breast Imaging
Camera (MBI) is a gamma camera that images accumulation of 99mTc-Sestamibi, a
radiopharmaceutical with high affinity for tissues of high cellularity and mitochondrial
content; a common characteristic of breast cancers.
This camera represents a significant advancement over its predecessors as it has improved
imaging geometry since it can be in direct contact with breast tissue and improved gamma
photon detection capability through the use of cadmium zinc telluride (CZT) crystals (a
semiconductor material) instead of NaI used in standard gamma cameras.
This project involves imaging patients with a baseline population risk of breast cancer,
referred for myocardial perfusion imaging (MPI). This is possible because 99mTc-sestamibi is
also used to image myocardial tissue. After the MPI study is performed to standard clinical
specifications, the patient is simply imaged with the MBI.
The primary endpoint of this project is to assess acceptability of this imaging device by
the patient through the use of a patient survey. Secondary endpoints are to correlate any
findings on the MBI studies with standard breast imaging modalities including mammogram,
ultrasound, and MRI. Image quality will be evaluated by the interpreting physicians. Also,
in an effort to reduce radiation absorbed dose to the female breast, low injected dose
images, obtained through post-processing by reframing acquired images, will be assessed for
acceptable image quality and diagnostic accuracy.
n/a
Observational Model: Cohort, Time Perspective: Prospective
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