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

NCT ID: NCT01368939

Last Updated: 2012-04-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2013-06-30

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.

Conditions

Breast Lesions

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hamilton Health Sciences Corporation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amit Singnurkar, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

HHSC, McMaster University, St. Joseph's Healthcare

Locations

Juravinski Hospital

Hamilton, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Tammy Murray

Role: CONTACT

tmurray@stjosham.on.ca

905-522-1155 ext. 35019

Facility Contacts

Tammy Murray, Research Officer

Role: primary

tmurray@stjosham.on.ca

905-522-1155 ext. 35019

Other Identifiers

HHSC-CPDC-001

Identifier Type: -

Identifier Source: org_study_id