Metastatic Lobular Breast CarcinomaPhase 1NCT07020806
[68Ga]Ga DOTA-5G as a Diagnostic Imaging Agent for Metastatic/Advanced Invasive Lobular Breast Cancer (LBC)
A Phase 1 study testing [68Ga]Ga DOTA-5G in people with Metastatic Lobular Breast Carcinoma, run by University of California, Davis at 1 site in United States.
Trial summary
This is a prospective study using [68Ga]Ga DOTA-5G PET/CT imaging in patients diagnosed with metastatic/advanced invasive lobular breast cancer (LBC). Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Metastatic Lobular Breast Carcinoma
- What is being tested?
- [68Ga]Ga DOTA-5G
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2025to Jun 2027
- Phase
- Phase 1
- 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 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (Ability to understand and willingness to sign a written informed consent document.
- Men and women age ≥ 18 yrs
- Confirmed presence of metastatic/advanced invasive lobular breast cancer and measurable disease per RECIST (version 1.1) or PERCIST
- Available archival tumor tissue
- Eastern Cooperative Oncology Group Performance Status ≤ 2
- Hematologic parameters defined as: Absolute neutrophil count (ANC) ≥ 1000 cells/mm3,Platelet count ≥ 100,000/mm3, Hemoglobin ≥ 8 g/dL.
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- Blood chemistry levels defined as: AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN), Total bilirubin ≤ 2 times ULN, eGFR >60 mL/min/1.73m*2
- Anticipated life expectancy ≥ 3 months
- Able to remain motionless for up to 30-60 minutes per scan.
Who cannot join
- Pregnant and lactating women
- Prisoners
- Concurrent malignancy of a different histology that could confound imaging interpretation.
- Patients who cannot undergo PET/CT scanning because of weight limits(>350lbs)
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, 1 recruiting
- Recruiting
University of California Davis
Sacramento, California, 95817
Julie L Sutcliffe, 916-734-5536, jlsutcliffe@health.ucdavis.edu
Julie Sutcliffe
About this study
This is a prospective study using [68Ga]Ga DOTA-5G PET/CT imaging in patients diagnosed with metastatic/advanced invasive lobular breast cancer (LBC).
Read the detailed description
This is a phase I investigator-initiated study that will investigate [68Ga]Ga DOTA-5G in patients with metastatic/advanced invasive LBC. 30 patients diagnosed with LBC will be enrolled over a 24-month period.
We hypothesize that a) [68Ga]Ga DOTA-5G will detect lesions in patients with invasive LBC, b) [68Ga]Ga DOTA-5G will be safe and well tolerated, and that c) [68Ga]Ga DOTA-5G PET/CT is more sensitive than 18F-FDG PET/CT at detecting lesions.
- Conditions
- Metastatic Lobular Breast Carcinoma
- Being tested
- [68Ga]Ga DOTA-5G
- Medical subject headings
- Carcinoma, Lobular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga DOTA-5GDrug
Patients will be injected with up to 5 mCi of [68Ga]Ga DOTA-5G and imaged at 1 and 2 hours post injection.
| Study group | Role | What they receive |
|---|---|---|
| [68Ga]Ga-DOTA-5G PET/CT imaging | Experimental | Following an injection of up to 5 mCi of [68Ga]Ga DOTA-5G patients will be undergo PET/CT scans. Receives: Drug: [68Ga]Ga DOTA-5G |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ability of [68Ga]Ga DOTA-5G PET/CT imaging to detect lesions
To assess the ability of [68Ga]Ga DOTA-5G PET/CT imaging to detect lesions. Following injection of [68Ga]Ga DOTA-5G patients will be imaged at 1 and 2 hours. Regions of interest will be drawn around lesions and standard uptake values (SUV) calculated. Detection of metastasis by [68Ga]Ga DOTA-5G PET/CT imaging, positive vs. negative based on if SUVmax >2-fold above normal brain, bone, lung, or liver of [68Ga]Ga DOTA-5G in at least one lesion assessed by [68Ga]Ga DOTA-5G PET/CT and identified on [18F]-FDG PET/CT diagnostic imaging.
Measured: 2 hours from time of injection
Safety and tolerability of [68Ga]Ga DOTA-5G based on the incidence of adverse events using CTCAE v 5.0
To evaluate the safety and tolerability of [68Ga]Ga DOTA-5G patients will be followed for up to 7 days for AEs using CTCAE v 5.0.
Measured: Up to 7 days from time of injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start18 Nov 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Lobular Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Helen K Chew, University of California Davis, Dr. Cameron Foster, University of California Davis, Society of Nuclear Medicine and Molecular Imaging
- Responsible party
- Principal investigator, Julie L. Sutcliffe, Ph.D, University of California, Davis
- Investigators
- Julie Sutcliffe, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020806
- Sponsor's protocol ID
- 2213682
- Status last verified
- Sep 2026
- First submitted
- 21 May 2025
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [68Ga]Ga DOTA-5G as a Diagnostic Imaging Agent for Metastatic/Advanced Invasive Lobular Breast Cancer (LBC)
- ClinicalTrials.gov ID
- NCT07020806
- Acronym / sponsor ID
- 2213682
- Conditions
- Metastatic Lobular Breast Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Dr. Helen K Chew, University of California Davis, Dr. Cameron Foster, University of California Davis, Society of Nuclear Medicine and Molecular Imaging
- Study start
- 18 Nov 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 13 Jun 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.
This is a prospective study using [68Ga]Ga DOTA-5G PET/CT imaging in patients diagnosed with metastatic/advanced invasive lobular breast cancer (LBC).
Detailed description
This is a phase I investigator-initiated study that will investigate [68Ga]Ga DOTA-5G in patients with metastatic/advanced invasive LBC. 30 patients diagnosed with LBC will be enrolled over a 24-month period.
We hypothesize that a) [68Ga]Ga DOTA-5G will detect lesions in patients with invasive LBC, b) [68Ga]Ga DOTA-5G will be safe and well tolerated, and that c) [68Ga]Ga DOTA-5G PET/CT is more sensitive than 18F-FDG PET/CT at detecting lesions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [68Ga]Ga-DOTA-5G PET/CT imaging | Experimental | Drug: [68Ga]Ga DOTA-5GFollowing an injection of up to 5 mCi of [68Ga]Ga DOTA-5G patients will be undergo PET/CT scans. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- (Ability to understand and willingness to sign a written informed consent document.
- Men and women age ≥ 18 yrs
- Confirmed presence of metastatic/advanced invasive lobular breast cancer and measurable disease per RECIST (version 1.1) or PERCIST
- Available archival tumor tissue
- Eastern Cooperative Oncology Group Performance Status ≤ 2
Key exclusion criteria (4 listed)
- Pregnant and lactating women
- Prisoners
- Concurrent malignancy of a different histology that could confound imaging interpretation.
- Patients who cannot undergo PET/CT scanning because of weight limits(>350lbs)
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 |
|---|---|---|
| [68Ga]Ga DOTA-5GPatients will be injected with up to 5 mCi of [68Ga]Ga DOTA-5G and imaged at 1 and 2 hours post injection. | Drug | [68Ga]Ga-DOTA-5G PET/CT imaging |
Primary outcome
The ability of [68Ga]Ga DOTA-5G PET/CT imaging to detect lesions
Time frame: 2 hours from time of injection
To assess the ability of [68Ga]Ga DOTA-5G PET/CT imaging to detect lesions. Following injection of [68Ga]Ga DOTA-5G patients will be imaged at 1 and 2 hours. Regions of interest will be drawn around lesions and standard uptake values (SUV) calculated. Detection of metastasis by [68Ga]Ga DOTA-5G PET/CT imaging, positive vs. negative based on if SUVmax >2-fold above normal brain, bone, lung, or liver of [68Ga]Ga DOTA-5G in at least one lesion assessed by [68Ga]Ga DOTA-5G PET/CT and identified on [18F]-FDG PET/CT diagnostic imaging.
Safety and tolerability of [68Ga]Ga DOTA-5G based on the incidence of adverse events using CTCAE v 5.0
Time frame: Up to 7 days from time of injection
To evaluate the safety and tolerability of [68Ga]Ga DOTA-5G patients will be followed for up to 7 days for AEs using CTCAE v 5.0.
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 14 Sep 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.
Julie Sutcliffe, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [68Ga]Ga DOTA-5G in people with Metastatic Lobular Breast Carcinoma, run by University of California, Davis 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 9 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 14 Sep 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Julie Sutcliffe, PhD (916-734-5536, jlsutcliffe@health.ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ability of [68Ga]Ga DOTA-5G PET/CT imaging to detect lesions (time frame: 2 hours from time of injection). The study lists 2 primary outcomes in all. 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 14 Sep 2026.