Completed
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
What is being tested
F-Var3 PET/CT
+ Blood draw
Diagnostic TestOther
Who is being recruted
Breast Diseases+3
+ Breast Neoplasms
+ Neoplasms
Over 18 Years
+9 Eligibility Criteria
How is the trial designed
Diagnostic Study
Phase 1
Interventional
Study Start: August 2019
Summary
Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: August 9, 2019
Actual date on which the first participant was enrolled.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.
Official TitlePhase 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
Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
6 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Breast DiseasesBreast NeoplasmsNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases
Criteria
5 inclusion criteria required to participate
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
Show More Criteria
4 exclusion criteria prevent from participating
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalBreast cancer
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
Memorial Sloan-Kettering Cancer Center
New York, United StatesOpen Memorial Sloan-Kettering Cancer Center in Google MapsCompletedOne Study Center