Breast LesionsROSENCT01368939
Investigation of High Resolution Nuclear Breast Imaging Camera (MBI) in Patients Administered Tc-99m Sestamibi (ROSE)
An observational study of Breast Lesions, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Lesions
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2012to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Juravinski Hospital
Hamilton, Ontario, L8B 1C3
Tammy Murray, Research Officer, 905-522-1155 ext. 35019, tmurray@stjosham.on.ca
About this study
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)
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.
Read more
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
- Keywords
- breast imaging, MBI, dose reduction, Tc-99m, imaging, cardiac
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2011 (estimated)
- Study startMar 2012
- Primary completionSep 2012 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amit Singnurkar, MD, FRCPC, Principal investigator, HHSC, McMaster University, St. Joseph's Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01368939
- Sponsor's protocol ID
- HHSC-CPDC-001
- Acronym
- ROSE
- Status last verified
- Apr 2012
- First submitted
- 7 Jun 2011
- Last updated
- 23 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01368939
- Acronym / sponsor ID
- ROSE / HHSC-CPDC-001
- Conditions
- Breast Lesions
- Keywords
- breast imaging, MBI, dose reduction, Tc-99m, imaging, cardiac
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 8 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amit Singnurkar, MD, FRCPC principal investigator
HHSC, McMaster University, St. Joseph's Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Lesions, run by Hamilton Health Sciences Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tammy Murray (905-522-1155 ext. 35019, tmurray@stjosham.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2012; AzTrials last refreshed its copy on 7 Nov 2026.