NCT07915297Not yet recruitingPhase 1
Safety and Biodistribution of [68Ga]Ga DOTA-5G in Subjects With Metastatic Breast Cancer (BC)
A Phase I Study to Evaluate the Safety and Biodistribution of [68Ga]Ga DOTA-5G in Subjects With Metastatic Breast Cancer (BC)
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
This is a prospective study using [68Ga]Ga DOTA-5G PET/CT imaging in patients diagnosed with metastatic breast cancer (BC).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 29 Oct 2026
- Start date
- 15 Nov 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Luminance Biosciences Inc
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07915297
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 10
- From 15 Nov 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with confirmed metastatic breast cancer who can have a PET/CT scan with the imaging agent [68Ga]Ga DOTA-5G.
- Age
- 18 to 89 years
- Sex
- Men and women can join.
- Disease stage
- Confirmed metastatic breast cancer.
Main reasons for not taking part
- Pregnant or breastfeeding women
- Prisoners
- Another cancer of a different type that could confuse the scan results
- Weight over 450 lbs, too heavy for the PET/CT scanner
- Cannot stay motionless for 30-60 minutes per scan
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent malignancy of a different histology that could confound imaging interpretation.
Other
- Pregnant and lactating women
- Prisoners
- Patients who cannot undergo PET/CT scanning because of weight limits(>450lbs)
Who the study is looking for
- 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.
Age in the registry: 18 years to 89 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Icon Cancer Center | Nedlands | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.