Breast Cancer DetectionMBI-GB-PilotNCT07114679
Molecular Breast Imaging (MBI)-Guided Biopsy
A study testing Molecular Breast Imaging and MBI-guided biopsy in people with Breast Cancer Detection and Breast Neoplasm, run by Smart Breast Corp. at 1 site in United States.
Trial summary
The goal of this pilot clinical trial is to demonstrate supplemental screening MBI (molecular breast imaging) in women with dense breasts. The main questions it aims to answer are: Does screening MBI find more cancer than screening DBT (3D mammography, digital breast tomosynthesis? Does screening MBI result in more… Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer Detection, Breast Neoplasm, Molecular Imaging
- What is being tested?
- Molecular Breast Imaging and MBI-guided biopsy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2027to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- dense breasts (BI-RADS C or D) on screening DBT
Who cannot join
- pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Radiology Clinical Research Manager, 214-648-7754, Charlton.Starcke@UTSouthwestern.edu
About this study
Official title: Molecular Breast Imaging (MBI)-Guided Biopsy Pilot SBIR
The goal of this pilot clinical trial is to demonstrate supplemental screening MBI (molecular breast imaging) in women with dense breasts. The main questions it aims to answer are:
- Does screening MBI find more cancer than screening DBT (3D mammography, digital breast tomosynthesis?
- Does screening MBI result in more call-backs for biopsy than DBT?
- How well does MBI-guided biopsy conform with pathology reports?
Read more
Researchers will compare screening MBI to screening DBT to see if MBI is more sensitive to detecting cancer in women with dense breasts.
Participants will
- Receive both screening DBT and screening MBI
- Receive either DBT-guided or MBI-guided biopsy (randomly assigned), if required by the screening images
Read the detailed description
This is a pilot single-group crossover screening clinical trial comparing screening MBI (molecular breast imaging) to screening DBT (3D mammography, digital breast tomosynthesis. Women who have recently completed their annual screening DBT will be assessed for breast density. If they have BI-RADS density C or D (dense breasts), they are eligible for this study. After consent, participants will receive a supplemental screening MBI (crossover from DBT). Both screenings will be read while blinded to knowledge of the other. After independent reporting, a Conciliation Conference will compare the two, and a consensus report will be prepared.
If biopsy is required on the consensus basis of both image sets, then the participant will be randomly assigned to DBT-guided or MBI-guided biopsy. If only one modality has visible lesions that require biopsy, then that modality will be assigned.
The primary outcome measure is Cancer Detection Rate. Secondary outcome measures include Biopsy Callback Rate, Concordance Rate between MBI biopsy sample images and pathology, Time Duration of Biopsy, and Accuracy of Lesion Targeting.
- Being tested
- Molecular Breast Imaging, MBI-guided biopsy
- Keywords
- screening, crossover, single-group, pilot, biopsy, randomized assignment, dense breasts, MBI, molecular imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular Breast ImagingDevice
Also called MBI
MBI is a molecular imaging (nuclear medicine) technique using a low dose i.v. radiopharmaceutical injection and solid-state gamma cameras to image the breast, where cancer mitochondria avidly take up the radiopharmaceutical.
MBI-guided biopsyDevice
Two stereotactic MBI views of the breast produce a precise 3D location for each lesion targeted for biopsy. A vacuum-assisted core biopsy needle is guided to the lesion position.
| Study group | Role | What they receive |
|---|---|---|
| Breast screening | Active comparator | Screening DBT and screening MBI are compared in women with dense breasts. Then, DBT-guided biopsy and MBI-guided biopsy are compared. Receives: Device: Molecular Breast Imaging; Device: MBI-guided biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer Detection Rate
The number of cancers found by a particular modality compared to the number of women with dense breasts screened by that modality.
Measured: less than one day
Secondary outcomes (3)
Concordance Rate
MBI-guided biopsies include an MBI image of the biopsy tissue samples in a Petri dish. Comparison of that image with the pathology report yields concordance.
Measured: less than a day
Biopsy Call-Back Rate
The percentage of women with dense breasts screened by a particular modality who have a suspicious lesion on their screening and they require biopsy.
Measured: less than a day
Duration of Biopsy
The amount of time that the modality-guided biopsy took to complete.
Measured: less than a day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study startJun 2027 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer DetectionStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Every participant (dense breast woman) will receive both screening DBT and screening MBI (crossover). If biopsy is required, participant will be randomly assigned to either DBT-guided or MBI-guided biopsy.
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Smart Breast Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Texas, Southwestern Medical Center at Dallas, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- James W Hugg, PhD, Principal investigator, Smart Breast Corp.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114679
- Sponsor's protocol ID
- MBI_Biopsy_Pilot_SBIR
- Acronym
- MBI-GB-Pilot
- Status last verified
- Aug 2025
- First submitted
- 3 Aug 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: We will reconsider at the end of data acquisition.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Breast Imaging (MBI)-Guided Biopsy Pilot SBIR
- ClinicalTrials.gov ID
- NCT07114679
- Acronym / sponsor ID
- MBI-GB-Pilot / MBI_Biopsy_Pilot_SBIR
- Keywords
- screening, crossover, single-group, pilot, biopsy, randomized assignment, dense breasts, MBI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Smart Breast Corp.Industry (pharma, biotech, devices)
- Collaborators
- University of Texas, Southwestern Medical Center at Dallas, National Cancer Institute (NCI)
- Study start
- Jun 2027 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 11 Aug 2025 (actual)
- 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.
The goal of this pilot clinical trial is to demonstrate supplemental screening MBI (molecular breast imaging) in women with dense breasts. The main questions it aims to answer are:
- Does screening MBI find more cancer than screening DBT (3D mammography, digital breast tomosynthesis?
- Does screening MBI result in more call-backs for biopsy than DBT?
- How well does MBI-guided biopsy conform with pathology reports?
Researchers will compare screening MBI to screening DBT to see if MBI is more sensitive to detecting cancer in women with dense breasts.
Participants will
- Receive both screening DBT and screening MBI
- Receive either DBT-guided or MBI-guided biopsy (randomly assigned), if required by the screening images
Detailed description
This is a pilot single-group crossover screening clinical trial comparing screening MBI (molecular breast imaging) to screening DBT (3D mammography, digital breast tomosynthesis. Women who have recently completed their annual screening DBT will be assessed for breast density. If they have BI-RADS density C or D (dense breasts), they are eligible for this study. After consent, participants will receive a supplemental screening MBI (crossover from DBT). Both screenings will be read while blinded to knowledge of the other. After independent reporting, a Conciliation Conference will compare the two, and a consensus report will be prepared.
If biopsy is required on the consensus basis of both image sets, then the participant will be randomly assigned to DBT-guided or MBI-guided biopsy. If only one modality has visible lesions that require biopsy, then that modality will be assigned.
The primary outcome measure is Cancer Detection Rate. Secondary outcome measures include Biopsy Callback Rate, Concordance Rate between MBI biopsy sample images and pathology, Time Duration of Biopsy, and Accuracy of Lesion Targeting.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Every participant (dense breast woman) will receive both screening DBT and screening MBI (crossover). If biopsy is required, participant will be randomly assigned to either DBT-guided or MBI-guided biopsy.
| Arm | Type | Receives |
|---|---|---|
| Breast screening | Active comparator | Device: Molecular Breast Imaging, Device: MBI-guided biopsyScreening DBT and screening MBI are compared in women with dense breasts. Then, DBT-guided biopsy and MBI-guided biopsy are compared. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- dense breasts (BI-RADS C or D) on screening DBT
Key exclusion criteria (1 listed)
- pregnancy
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 ImagingAlso: MBIMBI is a molecular imaging (nuclear medicine) technique using a low dose i.v. radiopharmaceutical injection and solid-state gamma cameras to image the breast, where cancer mitochondria avidly take up the radiopharmaceutical. | Device | Breast screening |
| MBI-guided biopsyTwo stereotactic MBI views of the breast produce a precise 3D location for each lesion targeted for biopsy. A vacuum-assisted core biopsy needle is guided to the lesion position. | Device | Breast screening |
Primary outcome
Cancer Detection Rate
Time frame: less than one day
The number of cancers found by a particular modality compared to the number of women with dense breasts screened by that modality.
3 secondary outcomes
Concordance Rate
Time frame: less than a day
Biopsy Call-Back Rate
Time frame: less than a day
Duration of Biopsy
Time frame: less than a day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: No. We will reconsider at the end of data acquisition.
Related trials for Breast Cancer Detection
RecruitingPhase 2
Detecting Tumor DNA in the Blood of HR+/HER2-low Metastatic Breast Cancer Patients to Find Candidates for T-DXd Therapy
Breast Cancer Metastatic, Breast Cancer Stage IV
RecruitingObservational study
Avera Cancer Sequencing and Analytics Protocol (ASAP)
Cancer, Cancer Diagnosis
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingObservational study
EXActDNA-003 / NSABP B-64: Study of Molecular Residual Disease Detection in Breast Cancer (MRD)
Breast Cancer
RecruitingObservational study
Post-market Safety Study of LUMISIGHT
Hypersensitivity Reactions
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.
James W Hugg, PhD principal investigator
Smart Breast Corp.
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 and MBI-guided biopsy in people with Breast Cancer Detection and Breast Neoplasm, run by Smart Breast Corp. 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 11 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James W Hugg, PhD (724-584-3266, James.Hugg@SmartBreast.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer Detection Rate (time frame: less than one day). 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 11 Aug 2025.