Recruiting

MBI with Tc-99m Sestamibi

Sponsor:

Hamilton Health Sciences Corporation

Code:

NCT01368939

Conditions

Breast Lesions

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Study Details

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 ID

NCT01368939

Start date

Mar, 2012

Status verified date

Apr, 2012

Completion date

Jun, 2013

Anticipated

Primary completion date

Sep, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Central Contacts and Locations

Central contacts

Locations

Juravinski Hospital

Recruiting

Hamilton, Ontario, Canada, L8B 1C3

Contacts

Tammy Murray, Research Officer

905-522-1155tmurray@stjosham.on.ca

More Information

Sponsor

Hamilton Health Sciences Corporation

Last update posted

Apr 23, 2012

Last verified

Apr, 2012

Keywords

  • breast imaging
  • MBI
  • dose reduction
  • Tc-99m
  • imaging
  • cardiac

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hamilton Health Sciences Corporation on 2012-04-23.