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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04054986

Enrollment

Registered

2019-08-13

Start date

2019-08-09

Completion date

2020-09-18

Last updated

2025-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast Cancer, 18F-Var3, First in human, Acidosis imaging, Memorial Sloan Kettering Cancer Center, 19-147

Brief summary

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.

Interventions

DIAGNOSTIC_TESTF-Var3 PET/CT

Participants will undergo up to 5 serial F-Var3 PET/CT scans within 25 minutes of the injection of 18F-Var3, 30, 60, 120 and 240 minutes after injection of the 18FVar3.

OTHERBlood draw

Collection of blood for research tests before the injection, 30, 60, 120 and 240 min after the injection.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0	30 days after completion of study treatment and assessments	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026