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
1 other identifier
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 breast-cancer
Started Aug 2019
Shorter than P25 for phase_1 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2019
CompletedStudy Start
First participant enrolled
August 9, 2019
CompletedFirst Posted
Study publicly available on registry
August 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 18, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 18, 2020
CompletedMay 16, 2025
September 1, 2020
1.1 years
August 9, 2019
May 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0
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.
30 days after completion of study treatment and assessments
Study Arms (1)
Breast Cancer
EXPERIMENTALBreast cancer
Interventions
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.
Collection of blood for research tests before the injection, 30, 60, 120 and 240 min after the injection.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher Riedle, MD, PhD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2019
First Posted
August 13, 2019
Study Start
August 9, 2019
Primary Completion
September 18, 2020
Study Completion
September 18, 2020
Last Updated
May 16, 2025
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.