Study of the Imaging Agent 18F-Var3 in Patients With Breast Cancer

Phase 1

Completed

• Conditions: Breast Cancer
• Interventions: Diagnostic Test: F-Var3 PET/CT; Other: Blood draw

• Registration Number: NCT04054986
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-08-09
• Study First Submitted: 2019-08-09
• Study First Submitted QC: 2019-08-12
• Study First Posted: 2019-08-13
• Status Verified: 2020-09
• Primary Completion: 2020-09-18
• Study Completion: 2020-09-18
• Last Update Submitted: 2020-09-28
• Last Update Posted: 2020-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 6

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Breast Cancer	F-Var3 PET/CT	Breast cancer
Breast Cancer	Blood draw	Breast cancer

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States