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Not yet recruitingNCT07915297Updated Nov 4, 2026

Safety and Biodistribution of [68Ga]Ga DOTA-5G in Subjects With Metastatic Breast Cancer (BC)

A Phase 1 interventional study of [68Ga]Ga DOTA-5G in Metastatic Breast Cancer, sponsored by Luminance Biosciences Inc. Not yet recruiting at 1 site in Australia. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Luminance Biosciences Inc · Phase 1, Interventional, and Diagnostic

Updated Nov 4, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 89 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Metastatic Breast Cancer

Keywords

  • PET
  • Imaging
  • Diagnostic
  • Breast Cancer
03

In context

Breast Neoplasms

12,844 studies on the registry are indexed under Breast Neoplasms; 2,939 are open to participants now.

This study's planned enrollment of 10 is below the median of 72 across 9,517 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

This is the only study on the registry with Luminance Biosciences Inc as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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,
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    [68Ga]Ga DOTA-5G PET/CT imaging

    Drug: [68Ga]Ga DOTA-5G

Interventions

  • Drug[68Ga]Ga DOTA-5G

    Patients will be injected with up to 5 mCi of \[68Ga\]Ga DOTA-5G and imaged at 1 and 2 hours post injection

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: up to 7 days from time of injection

07

Study locations

1 site
  • Icon Cancer Center
    Nedlands, Washington 6009, Australia
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Dec 2027, 13 months later.

Of 308 industry-sponsored phase 1 interventional studies under Breast Neoplasms, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 57. This study's planned 13 months is below that.

Counting every sponsor, half of 648 studies reached it within 45 months; a quarter within 25 and three quarters within 66.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 29, 2026
First posted
Nov 4, 2026
StartEst.
Nov 15, 2026
Primary completionEst.
Dec 31, 2027
CompletionEst.
Jun 30, 2028
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07915297
Lead sponsor
Luminance Biosciences Inc
Collaborators
Icon Cancer Center Hollywood, Icon Group, Ace Integrated Consulting
Responsible party
Sponsor
First posted
Nov 4, 2026
Start date
Nov 15, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Nov 4, 2026

Study contacts

Julie Sutcliffe, Ph.D
Contact
jlsutcliffe@luminancebio.com
5302048801
Zee Uys
Contact
Zee.Ais-Consulting@outlook.com
Julie Sutcliffe
study director · Luminance Biosciences Inc

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Gallium-68

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