Breast CancerTHORNNCT01062100
Study To Investigate the Feasibility and Safety of A Dedicated High Resolution Nuclear Breast Imaging Camera
A study testing nuclear breast imaging using MBI Gamma camera in people with Breast Cancer, run by Ontario Clinical Oncology Group (OCOG) at 1 site in Canada.
Trial summary
To evaluate the feasibility, acceptability and safety of using a molecular breast imaging (MBI) Gamma Camera in women at high risk of developing breast cancer Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- nuclear breast imaging using MBI Gamma camera
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2010to Feb 2013
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females ≥18 years of age
- Undergoing annual breast MRI because of a high risk of breast cancer due to any of the following:
- Known BRCA1 or BRCA2 mutation carriers, or is untested for BRCA but is a first degree relative of a BRCA mutation carrier
- History of radiation to the chest between 10-30 years of age (e.g. Hodgkin's Disease)
- History of Cowdens or Li Fraumeni Syndrome
- A first degree relative with Cowdens or Li Fraumeni Syndrome
- Prior breast biopsy positive for lobular carcinoma in situ (LCIS) or atypical lobular hyperplasia or atypical ductal hyperplasia (ADH)
- Family history consistent with a hereditary breast cancer syndrome and estimated personal lifetime cancer risk ≥25% using the IBIS risk evaluator
Who cannot join
- Pregnant or lactating
- History of invasive breast cancer or ductal carcinoma in situ (DCIS)
- Unable to undergo MRI because of:
- Renal dysfunction with an estimated creatinine clearance of < 30 ml/min calculated using the Cockcroft-Gault formula
- Implanted ferrous metal prostheses
- Claustrophobia
Show all 11Show fewer
- Medical or psychological conditions that on assessment, make them unable to complete the procedure
- Known allergies to Gadolinium-DTPA
- Known allergies to Sestamibi (Miraluma or Cardiolite)
- Prior bilateral mastectomy
- Prior breast biopsy or surgery within 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Hamilton Prospective Pilot Study To Investigate the Feasibility and Safety of A Dedicated High Resolution Nuclear Breast Imaging Camera
To evaluate the feasibility, acceptability and safety of using a molecular breast imaging (MBI) Gamma Camera in women at high risk of developing breast cancer
- Conditions
- Breast Cancer
- Being tested
- nuclear breast imaging using MBI Gamma camera
- Keywords
- breast cancer, molecular breast imaging, MRI, gamma camera
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nuclear breast imaging using MBI Gamma cameraDevice
nuclear breast imaging using MBI Gamma camera in addition to MRI
| Study group | Role | What they receive |
|---|---|---|
| nuclear breast imaging | Experimental | nuclear breast imaging using MBI Gamma camera Receives: Device: nuclear breast imaging using MBI Gamma camera |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the feasibility, safety and acceptability to patients of the MBI Gamma camera.
Measured: 1 year
Secondary outcomes (1)
To explore the ability of the MBI Gamma camera to detect breast cancer.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionSep 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory Pond, Principal investigator, Ontario Clinical Oncology Group - McMaster UniversityKaren Gulenchyn, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01062100
- Sponsor's protocol ID
- OCOG-2009-THORN
- Acronym
- THORN
- Status last verified
- Feb 2013
- First submitted
- 2 Feb 2010
- Last updated
- 18 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hamilton Prospective Pilot Study To Investigate the Feasibility and Safety of A Dedicated High Resolution Nuclear Breast Imaging Camera
- ClinicalTrials.gov ID
- NCT01062100
- Acronym / sponsor ID
- THORN / OCOG-2009-THORN
- Conditions
- Breast Cancer
- Keywords
- breast cancer, molecular breast imaging, MRI, gamma camera
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)University, hospital or other
- Study start
- Feb 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 4 Feb 2010 (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.
To evaluate the feasibility, acceptability and safety of using a molecular breast imaging (MBI) Gamma Camera in women at high risk of developing breast cancer
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nuclear breast imaging | Experimental | Device: nuclear breast imaging using MBI Gamma cameranuclear breast imaging using MBI Gamma camera |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Females ≥18 years of age
- Undergoing annual breast MRI because of a high risk of breast cancer due to any of the following:
Key exclusion criteria (11 listed)
- Pregnant or lactating
- History of invasive breast cancer or ductal carcinoma in situ (DCIS)
- Unable to undergo MRI because of:
- Known allergies to Sestamibi (Miraluma or Cardiolite)
- Prior bilateral mastectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nuclear breast imaging using MBI Gamma cameranuclear breast imaging using MBI Gamma camera in addition to MRI | Device | nuclear breast imaging |
Primary outcome
To assess the feasibility, safety and acceptability to patients of the MBI Gamma camera.
Time frame: 1 year
1 secondary outcome
To explore the ability of the MBI Gamma camera to detect breast cancer.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2013.
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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.
Gregory Pond principal investigator
Ontario Clinical Oncology Group - McMaster University
Karen Gulenchyn principal investigator
Hamilton Health Sciences Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nuclear breast imaging using MBI Gamma camera in people with Breast Cancer, run by Ontario Clinical Oncology Group (OCOG) 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 8 inclusion and 11 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: finished, as of the sponsor's last update on 18 Feb 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the feasibility, safety and acceptability to patients of the MBI Gamma camera. (time frame: 1 year). It is what the study was designed to measure, not a finding.
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 18 Feb 2013.