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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Hamilton Health Sciences Corporation.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier:
NCT01368939
First received: June 7, 2011
Last updated: April 20, 2012
Last verified: April 2012
  Purpose

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
Breast Lesions

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Hamilton Health Sciences Corporation:

Estimated Enrollment: 150
Study Start Date: March 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01368939

Contacts
Contact: Tammy Murray 905-522-1155 ext 35019 tmurray@stjosham.on.ca

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

No publications provided

Responsible Party: Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT01368939     History of Changes
Other Study ID Numbers: HHSC-CPDC-001
Study First Received: June 7, 2011
Last Updated: April 20, 2012
Health Authority: Canada: Health Canada

Keywords provided by Hamilton Health Sciences Corporation:
breast imaging
MBI
dose reduction
Tc-99m
imaging
cardiac

ClinicalTrials.gov processed this record on April 22, 2014