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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07915297




Registration number
Help: Registration number
NCT07915297
Ethics application status
Help: Ethics application status
Date submitted
Help: Date submitted
29/10/2026
Date registered
Help: Date registered
4/11/2026
Date last updated
Help: Date last updated
4/11/2026

Titles & IDs
Public title
Safety and Biodistribution of [68Ga]Ga DOTA-5G in Subjects With Metastatic Breast Cancer (BC)
Scientific title
A Phase I Study to Evaluate the Safety and Biodistribution of [68Ga]Ga DOTA-5G in Subjects With Metastatic Breast Cancer (BC)
Additional trial identifiers [1] 0 0
2026-06-1062
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Metastatic Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Treatment: Drugs - [68Ga]Ga DOTA-5G

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


Treatment: Drugs: [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
Intervention code [1] 0 0
Treatment: Drugs
Description of the comparator or control
Control group

Outcomes
Primary outcome [1] 0 0
The ability of [68Ga]Ga DOTA-5G PET/CT imaging to detect lesions
Timepoint [1] 0 0
2 hours from time of injection
Secondary outcome [1] 0 0
Safety and tolerability [68Ga]Ga DOTA-5G based on the incidence of of adverse events using CTCAE v5.0.
Timepoint [1] 0 0
up to 7 days from time of injection

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
89 Years
Sex
Both males and females
Healthy volunteers
No
Key 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)

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
15/11/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2028
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Washingto
Recruitment hospital [1] 0 0
Icon Cancer Center - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Luminance Biosciences Inc
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Icon Cancer Center Hollywood
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Icon Group
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Ace Integrated Consulting
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Julie Sutcliffe
Address 0 0
Luminance Biosciences Inc
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Julie Sutcliffe, Ph.D
Address 0 0
Country 0 0
Phone 0 0
5302048801
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07915297