Clinical trial · Interventional
[68Ga]Ga DOTA-5G as a Diagnostic Imaging Agent for Metastatic/Advanced Invasive Lobular Breast Cancer (LBC)
NCT07020806CI-TRIAL-00106171recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
This is a prospective study using \[68Ga\]Ga DOTA-5G PET/CT imaging in patients diagnosed with metastatic/advanced invasive lobular breast cancer (LBC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Lobular Breast Carcinoma | Breast Lobular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [68Ga]Ga DOTA-5G | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [68Ga]Ga-DOTA-5G PET/CT imaging
- description
- Following an injection of up to 5 mCi of \[68Ga\]Ga DOTA-5G patients will be undergo PET/CT scans.
- interventionNames
- Drug: [68Ga]Ga DOTA-5G
Primary outcomes (2)
- measure
- The ability of [68Ga]Ga DOTA-5G PET/CT imaging to detect lesions
- timeFrame
- 2 hours from time of injection
- description
- 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.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 89 Years
Show eligibility criteria text
Inclusion Criteria: * (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. * 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. 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(\>350lbs)
References
Publications (0)
Data not yet available
No reference posted for this study.