Breast CancerEarly Phase 1NCT04016818
Pilot Breast-Dedicated PET Camera With 1 Millimeter Spatial Resolution
A Early Phase 1 study testing 18F-FDG and Breast-dedicated PET camera in people with Breast Cancer, run by Stanford University at 1 site in United States.
Trial summary
This is a research study of a novel, "breast-dedicated" positron emission tomography (PET) camera with 1 millimeter spatial resolution. The main goal of the study is for the personnel to understand practical and logistical issues with using the camera in the clinic Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- 18F-FDG and Breast-dedicated PET camera
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2026to Dec 2027
- Phase
- Early Phase 1
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy-confirmed breast cancer measuring ≥ 5 mm on mammogram or ultrasound.
- Prior diagnostic imaging test(s) with another modality such as MRI, CT, or x-ray mammography (or other applicable imaging modalities) within 60 days prior to the study date.
- Documented written informed consent document.
Who cannot join
- 1. Additional condition, or extenuating circumstance that, in the opinion of the investigator, may interfere with study compliance.
- Known allergies to FDG
- Pregnant or nursing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of a Breast-Dedicated PET Camera With 1 Millimeter Spatial Resolution
This is a research study of a novel, "breast-dedicated" positron emission tomography (PET) camera with 1 millimeter spatial resolution. The main goal of the study is for the personnel to understand practical and logistical issues with using the camera in the clinic
Read the detailed description
Primary Objective To obtain initial experience using the novel, breast-dedicated PET camera design in the breast imaging clinic.
Secondary Objectives To understand, given the 10-fold higher sensitivity of this novel camera, how low we can go with administered tracer dose, and, given the >100-fold better volumetric spatial resolution, understand the achievable image quality.
- Conditions
- Breast Cancer
- Being tested
- 18F-FDG, Breast-dedicated PET 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.
18F-FDGDrug
Also called 18F-fluorodeoxiglucose, 18F-FDG radiotracer
Participant will be injected IV (intravenously) with 10 ± 2 mCi of 18F-FDG.
Breast-dedicated PET cameraDevice
Breast-dedicated PET camera designed by Stanford satellite radiochemistry facility
| Study group | Role | What they receive |
|---|---|---|
| 18-F FDG Study using Breast-Dedicated PET Camera | Experimental | Breast-Dedicated PET Camera will be used with standard PET 18-F FDG tracer dose Receives: Drug: 18F-FDG; Device: Breast-dedicated PET camera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image quality with the breast-dedicated PET camera
Feasibility of the pilot breast-dedicated PET camera will be assessed on the basis of whether acceptable images are obtained. Images will be assessed and graded as 1 of 3 quality ratings: excellent, good, and poor. The outcome will be reported as the number of images that are excellent, good, and poor, a number without dispersion.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study startJun 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Why it stopped: Awaiting more funding to build a more stable technology.
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.
- More trials run by Stanford UniversityThe 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
- Early Phase 1
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wendy B DeMartini, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016818
- Sponsor's protocol ID
- IRB-50877
- Other IDs
- BRS0102, IRB-50877, NCI-2019-03810
- Status last verified
- May 2026
- First submitted
- 2 Jul 2019
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Breast-Dedicated PET Camera With 1 Millimeter Spatial Resolution
- ClinicalTrials.gov ID
- NCT04016818
- Acronym / sponsor ID
- IRB-50877
- Conditions
- Breast Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Awaiting more funding to build a more stable technology.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 12 Jul 2019 (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.
This is a research study of a novel, "breast-dedicated" positron emission tomography (PET) camera with 1 millimeter spatial resolution. The main goal of the study is for the personnel to understand practical and logistical issues with using the camera in the clinic
Detailed description
Primary Objective To obtain initial experience using the novel, breast-dedicated PET camera design in the breast imaging clinic.
Secondary Objectives To understand, given the 10-fold higher sensitivity of this novel camera, how low we can go with administered tracer dose, and, given the >100-fold better volumetric spatial resolution, understand the achievable image quality.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18-F FDG Study using Breast-Dedicated PET Camera | Experimental | Drug: 18F-FDG, Device: Breast-dedicated PET cameraBreast-Dedicated PET Camera will be used with standard PET 18-F FDG tracer dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Biopsy-confirmed breast cancer measuring ≥ 5 mm on mammogram or ultrasound.
- Prior diagnostic imaging test(s) with another modality such as MRI, CT, or x-ray mammography (or other applicable imaging modalities) within 60 days prior to the study date.
- Documented written informed consent document.
Key exclusion criteria (3 listed)
- 1. Additional condition, or extenuating circumstance that, in the opinion of the investigator, may interfere with study compliance.
- Known allergies to FDG
- Pregnant or nursing.
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 |
|---|---|---|
| 18F-FDGAlso: 18F-fluorodeoxiglucose, 18F-FDG radiotracerParticipant will be injected IV (intravenously) with 10 ± 2 mCi of 18F-FDG. | Drug | 18-F FDG Study using Breast-Dedicated PET Camera |
| Breast-dedicated PET cameraBreast-dedicated PET camera designed by Stanford satellite radiochemistry facility | Device | 18-F FDG Study using Breast-Dedicated PET Camera |
Primary outcome
Image quality with the breast-dedicated PET camera
Time frame: 1 day
Feasibility of the pilot breast-dedicated PET camera will be assessed on the basis of whether acceptable images are obtained. Images will be assessed and graded as 1 of 3 quality ratings: excellent, good, and poor. The outcome will be reported as the number of images that are excellent, good, and poor, a number without dispersion.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- 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.
Wendy B DeMartini principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 18F-FDG and Breast-dedicated PET camera in people with Breast Cancer, run by Stanford University 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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 29 May 2026. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Image quality with the breast-dedicated PET camera (time frame: 1 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 29 May 2026.