Investigation of High Resolution Nuclear Breast Imaging Camera (MBI) in Patients Administered Tc-99m Sestamibi (ROSE) (ROSE)
|ClinicalTrials.gov Identifier: NCT01368939|
Recruitment Status : Unknown
Verified April 2012 by Hamilton Health Sciences Corporation.
Recruitment status was: Recruiting
First Posted : June 8, 2011
Last Update Posted : April 23, 2012
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|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)|
|Study Start Date :||March 2012|
|Estimated Primary Completion Date :||September 2012|
|Estimated Study Completion Date :||June 2013|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01368939
|Contact: Tammy Murray||905-522-1155 ext firstname.lastname@example.org|
|Hamilton, Ontario, Canada, L8B 1C3|
|Contact: Tammy Murray, Research Officer 905-522-1155 ext 35019 email@example.com|
|Principal Investigator:||Amit Singnurkar, MD, FRCPC||HHSC, McMaster University, St. Joseph's Healthcare|