Metastatic Breast CancerPhase 1NCT07915297
Safety and Biodistribution of [68Ga]Ga DOTA-5G in Subjects With Metastatic Breast Cancer (BC)
A Phase 1 study testing [68Ga]Ga DOTA-5G in people with Metastatic Breast Cancer, run by Luminance Biosciences Inc at 1 site in Australia.
Trial summary
This is a prospective study using [68Ga]Ga DOTA-5G PET/CT imaging in patients diagnosed with metastatic breast cancer (BC). Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Metastatic Breast Cancer
- 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
- 10 participants
- Where
- 1 siteAustralia
- Study dates
- 15 Nov 2026to 30 Jun 2028
- 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 breast cancer
- Eastern Cooperative Oncology Group Performance Status ≤ 2
- Hematologic parameters defined as:
- Absolute neutrophil count (ANC) ≥ 1x 109 /L,
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- Platelet count ≥ 100x 109 /L,
- Hemoglobin ≥ 80 g/L.
- Blood chemistry levels defined as:
- AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN),
- Total bilirubin ≤ 2 times ULN,
- Creatinine ≤ 2 times ULN.
- 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(>450lbs)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zee Uys contact
Australia1 site
Icon Cancer Center
Nedlands, Washington, 6009
Tenille Baker, 0737374500, Research.Governance@icon.team
Nat Lenzo, MD
About this study
Official title: A Phase I Study to Evaluate the Safety and Biodistribution of [68Ga]Ga DOTA-5G in Subjects With Metastatic Breast Cancer (BC)
This is a prospective study using [68Ga]Ga DOTA-5G PET/CT imaging in patients diagnosed with metastatic breast cancer (BC).
Read the detailed description
This is a phase I study that will investigate [68Ga]Ga DOTA-5G in patients with metastatic BC. 10 patients diagnosed with invasive BC will be enrolled.
- Conditions
- Metastatic Breast Cancer
- Being tested
- [68Ga]Ga DOTA-5G
- Keywords
- PET, Imaging, Diagnostic, Breast Cancer
- Medical subject headings
- Breast Neoplasms, Disease
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 | Not described 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 to detect lesions: detection of metastasis by [68Ga]Ga DOTA-5G , positive vs. negative based on if SUVmax above background 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
Secondary outcomes (1)
Safety and tolerability [68Ga]Ga DOTA-5G based on the incidence of of adverse events using CTCAE v5.0.
To evaluate the Safety and tolerability [68Ga]Ga DOTA-5G patients will be followed for up to 7 days for AEs using CTCAE v5.0.
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 posted4 Nov 2026
- Study start15 Nov 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luminance Biosciences Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Icon Cancer Center Hollywood, Icon Group, Ace Integrated Consulting
- Responsible party
- Sponsor
- Investigators
- Julie Sutcliffe, Study director, Luminance Biosciences Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915297
- Sponsor's protocol ID
- 2026-06-1062
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety and Biodistribution of [68Ga]Ga DOTA-5G in Subjects With Metastatic Breast Cancer (BC)
- ClinicalTrials.gov ID
- NCT07915297
- Acronym / sponsor ID
- 2026-06-1062
- Conditions
- Metastatic Breast Cancer
- Keywords
- PET, Imaging, Diagnostic, Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Luminance Biosciences IncIndustry (pharma, biotech, devices)
- Collaborators
- Icon Cancer Center Hollywood, Icon Group, Ace Integrated Consulting
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 4 Nov 2026 (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 breast cancer (BC).
Detailed description
This is a phase I study that will investigate [68Ga]Ga DOTA-5G in patients with metastatic BC. 10 patients diagnosed with invasive BC will be enrolled.
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-5G |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Ability to understand and willingness to sign a written informed consent document.
- Men and women age ≥ 18 yrs
- Confirmed presence of metastatic breast cancer
- Eastern Cooperative Oncology Group Performance Status ≤ 2
- Hematologic parameters defined as:
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(>450lbs)
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 to detect lesions: detection of metastasis by [68Ga]Ga DOTA-5G , positive vs. negative based on if SUVmax above background 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.
1 secondary outcome
Safety and tolerability [68Ga]Ga DOTA-5G based on the incidence of of adverse events using CTCAE v5.0.
Time frame: up to 7 days from time of injection
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 4 Nov 2026.
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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.
Zee Uys contact
Julie Sutcliffe study director
Luminance Biosciences Inc
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 Breast Cancer, run by Luminance Biosciences Inc at 1 site in Australia.
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 14 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: opening soon, as of the sponsor's last update on 4 Nov 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 Australia. 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, Ph.D (5302048801, jlsutcliffe@luminancebio.com), 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). 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 4 Nov 2026.