Clinical trial · Interventional
Study of the Imaging Agent 18F-Var3 in Patients With Breast Cancer
Phase 1 Study Using First-in-Human Acidosis Imaging With [18F]AlF-cysVar3 pHLIP® (18F-Var3) in Patients With Breast Cancer for Determination of Safety, Biodistribution and Radiation Dosimetry
NCT04054986CI-TRIAL-00089784completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to measure the safety of the investigational imaging agent, 18F-Var3 and to determine if it is helpful in providing information about how tumor tissues behave.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood draw | Other | — | UNRESOLVED |
| F-Var3 PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Breast Cancer
- description
- Breast cancer
- interventionNames
- Diagnostic Test: F-Var3 PET/CT
- Other: Blood draw
Primary outcomes (1)
- measure
- Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0
- timeFrame
- 30 days after completion of study treatment and assessments
- description
- The safety of patients will be evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Grade 1 and grade 2 toxicities are considered safe.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or greater * Biopsy-proven breast malignancy * \>/= 1 viable lesion, \>/= 1 cm, confirmed on CT, MR, or FDG PET/CT within 4 weeks of protocol enrollment * Newly diagnosed or recurrent disease, on or off therapy * ECOG performance of 0-2 \*Note: Lesions are considered viable if they are stable or increasing soft tissue lesions, or if they are FDG-avid bone lesions Exclusion Criteria: * Life expectancy \< 3 months * Pregnancy or lactation * Biopsy or other surgical procedures within 48 hours prior to receiving study intervention * Patients who cannot undergo PT/CT scanning because of weight limits. PET/CT scanners may not be able to function with patients over 400 pounds
References
Publications (0)
Data not yet available
No reference posted for this study.