Investigation of High Resolution Nuclear Breast Imaging Camera (MBI) in Patients Administered Tc-99m Sestamibi (ROSE) (ROSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Hamilton Health Sciences Corporation

Brief Summary:

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
Breast Lesions

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects who have completed a cardiac stress test with Tc-99m Sestamibi (same day) will be eligible for enrollment into the study. Females over the age of 18 and signed consent form. Subjects will be recruited from the cardiac care clinic on Site.

Inclusion Criteria:

  • females over 18 years of age
  • completed a cardiac stress test using Tc-99m Sestamibi as the radiotracer prior to MBI imaging on the same day.
  • signed consent form

Exclusion Criteria:

  • pregnant or lactating
  • history of invasive breast cancer or ductal carcinoma in situ
  • prior bilateral mastectomy
  • prior breast biopsy or surgery within 3 months
  • any other conditions that based on the investigator's judgement, may impact the ability of the patient to complete the study

Information from the National Library of Medicine

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 identifier (NCT number): NCT01368939

Contact: Tammy Murray 905-522-1155 ext 35019

Canada, Ontario
Juravinski Hospital Recruiting
Hamilton, Ontario, Canada, L8B 1C3
Contact: Tammy Murray, Research Officer    905-522-1155 ext 35019   
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Principal Investigator: Amit Singnurkar, MD, FRCPC HHSC, McMaster University, St. Joseph's Healthcare

Responsible Party: Hamilton Health Sciences Corporation Identifier: NCT01368939     History of Changes
Other Study ID Numbers: HHSC-CPDC-001
First Posted: June 8, 2011    Key Record Dates
Last Update Posted: April 23, 2012
Last Verified: April 2012

Keywords provided by Hamilton Health Sciences Corporation:
breast imaging
dose reduction

Additional relevant MeSH terms:
Technetium Tc 99m Sestamibi
Molecular Mechanisms of Pharmacological Action