Breast CancerSplit-DoseNCT01653964
Evaluation of Half-Dose Molecular Breast Imaging With Wide Beam Reconstruction Processing
A study testing Molecular breast imaging in people with Breast Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
The primary objective of this work is to determine if half-dose Molecular Breast Imaging (MBI) performed with 4 mCi Tc-99m sestamibi with or without Wide Beam Reconstruction applied can achieve image quality and diagnostic accuracy non-inferior to that of standard MBI performed with 8 millicurie (mCi) Tc-99m sestamibi. Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Molecular breast imaging
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to May 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subgroup 1, Patients with breast lesions:
- -At least one breast lesion detected by mammogram, ultrasound or breast MRI that measures < 20 mm in greatest dimension, presents as a mass, is considered suspicious or highly suggestive of malignancy according to the Breast Imaging Reporting and Data System Atlas criteria (BIRADS 4 or 5), and is scheduled for core-needle biopsy or surgical biopsy.
- OR
- -At least one breast lesion that measures between > 10 mm but < 20 mm in greatest dimension, presents as a mass, is biopsy-proven as malignant, and is scheduled for surgical resection.
- AND
- Age > 40 years
Show all 12Show fewer
- Negative pregnancy test, postmenopausal, or surgically sterilized
- Subgroup 2, Patients without known breast lesions:
- Negative screening mammogram performed at Mayo Clinic Rochester within 15 months prior to performance of study MBI
- No signs or symptoms of breast disease
- Age > 40 years
- Negative pregnancy test, postmenopausal, or surgically sterilized
Who cannot join
- Vacuum-assisted or excisional biopsy has been performed prior to the study MBI. Reason: these types of biopsies are more likely to remove all of the tumor
- MBI is performed after biopsy and neo-adjuvant chemotherapy is planned prior to surgery. Reason: true tumor size will not be able to be ascertained from the final pathology findings
- Breast implants. Reason: cases with breast implants will be easily identifiable on blinded interpretation to take place at the study end
- Suspected that breasts will not fit in the MBI field of view. Reason: cases that require tiled views or additional views will be easily identifiable on blinded interpretation to take place at the study end
- Only one breast remaining. Reason: unilateral cases will be easily identifiable on blinded interpretation to take place at the study end; injection timing is designed for bilateral views
- Pregnancy test (if necessary) is not negative, or the patient is unable to complete the pregnancy test
- Physically unable to sit upright and still remain still during two consecutive MBI studies over the course of a 2-hour period.
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this work is to determine if half-dose Molecular Breast Imaging (MBI) performed with 4 mCi Tc-99m sestamibi with or without Wide Beam Reconstruction applied can achieve image quality and diagnostic accuracy non-inferior to that of standard MBI performed with 8 millicurie (mCi) Tc-99m sestamibi.
Read the detailed description
Recent implementation of dose reduction strategies for Molecular Breast Imaging now allow performance of MBI at an administered dose of 8 mCi Tc-99m sestamibi, which is reduced from the previously used doses of 20-30 mCi. In order to safely introduce MBI as a screening modality, we aim to perform MBI using 4 mCi Tc-99m sestamibi. An image processing algorithm called Wide Beam Reconstruction (WBR) has been tailored for MBI technology with the goal of allowing either the current administered dose or current acquisition time to be reduced by half.
- Conditions
- Breast Cancer
- Being tested
- Molecular breast imaging
- Keywords
- suspicious, lesion, breast, cancer, screening, mammogram, negative
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular breast imagingDiagnostic test
Molecular breast imaging performed with injection of Tc-99m sestamibi and a dedicated gamma camera (Luma Gem, Gamma Medica)
| Study group | Role | What they receive |
|---|---|---|
| Molecular breast imaging | Experimental | Molecular Breast Imaging at 4 mCi dose and at 8 mCi dose, consecutively. Receives: Diagnostic Test: Molecular breast imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the Diagnostic Accuracy of 8 mCi Molecular Breast Imaging (MBI) With 4 mCi MBI.
Measured: At time of study (within 2 days after exam) and when enrollment has been reached (approximately 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Friends for an Earlier Breast Cancer Test
- Responsible party
- Principal investigator, Carrie Hruska, Mayo Clinic
- Investigators
- Carrie B Hruska, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01653964
- Sponsor's protocol ID
- 12-004437
- Acronym
- Split-Dose
- Status last verified
- Sep 2017
- First submitted
- 24 Jul 2012
- Last updated
- 18 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Half-Dose Molecular Breast Imaging With Wide Beam Reconstruction Processing
- ClinicalTrials.gov ID
- NCT01653964
- Acronym / sponsor ID
- Split-Dose / 12-004437
- Conditions
- Breast Cancer
- Keywords
- suspicious, lesion, breast, cancer, screening, mammogram, negative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Friends for an Earlier Breast Cancer Test
- Study start
- Jul 2012
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 31 Jul 2012 (estimated)
- Results
- Posted 18 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this work is to determine if half-dose Molecular Breast Imaging (MBI) performed with 4 mCi Tc-99m sestamibi with or without Wide Beam Reconstruction applied can achieve image quality and diagnostic accuracy non-inferior to that of standard MBI performed with 8 millicurie (mCi) Tc-99m sestamibi.
Detailed description
Recent implementation of dose reduction strategies for Molecular Breast Imaging now allow performance of MBI at an administered dose of 8 mCi Tc-99m sestamibi, which is reduced from the previously used doses of 20-30 mCi. In order to safely introduce MBI as a screening modality, we aim to perform MBI using 4 mCi Tc-99m sestamibi. An image processing algorithm called Wide Beam Reconstruction (WBR) has been tailored for MBI technology with the goal of allowing either the current administered dose or current acquisition time to be reduced by half.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Molecular breast imaging | Experimental | Diagnostic Test: Molecular breast imagingMolecular Breast Imaging at 4 mCi dose and at 8 mCi dose, consecutively. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- -At least one breast lesion detected by mammogram, ultrasound or breast MRI that measures < 20 mm in greatest dimension, presents as a mass, is considered suspicious or highly suggestive of malignancy according to the Breast Imaging Reporting and Data System Atlas criteria (BIRADS 4 or 5), and is scheduled for core-needle biopsy or surgical biopsy.
- OR
- -At least one breast lesion that measures between > 10 mm but < 20 mm in greatest dimension, presents as a mass, is biopsy-proven as malignant, and is scheduled for surgical resection.
- AND
- Age > 40 years
Key exclusion criteria (7 listed)
- Vacuum-assisted or excisional biopsy has been performed prior to the study MBI. Reason: these types of biopsies are more likely to remove all of the tumor
- MBI is performed after biopsy and neo-adjuvant chemotherapy is planned prior to surgery. Reason: true tumor size will not be able to be ascertained from the final pathology findings
- Breast implants. Reason: cases with breast implants will be easily identifiable on blinded interpretation to take place at the study end
- Suspected that breasts will not fit in the MBI field of view. Reason: cases that require tiled views or additional views will be easily identifiable on blinded interpretation to take place at the study end
- Only one breast remaining. Reason: unilateral cases will be easily identifiable on blinded interpretation to take place at the study end; injection timing is designed for bilateral views
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 |
|---|---|---|
| Molecular breast imagingMolecular breast imaging performed with injection of Tc-99m sestamibi and a dedicated gamma camera (Luma Gem, Gamma Medica) | Diagnostic test | Molecular breast imaging |
Primary outcome
Compare the Diagnostic Accuracy of 8 mCi Molecular Breast Imaging (MBI) With 4 mCi MBI.
Time frame: At time of study (within 2 days after exam) and when enrollment has been reached (approximately 24 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic You Tube ChannelLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Carrie B Hruska, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Molecular breast imaging in people with Breast Cancer, run by Mayo Clinic at 1 site in United States.
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 12 inclusion and 7 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 Sep 2017. 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 United States. 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?
Yes. Results are posted in the registry (first posted 18 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Compare the Diagnostic Accuracy of 8 mCi Molecular Breast Imaging (MBI) With 4 mCi MBI. (time frame: At time of study (within 2 days after exam) and when enrollment has been reached (approximately 24 months)). 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 Sep 2017; AzTrials last refreshed its copy on 6 Nov 2026.