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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04054986
• Other study ID #: 19-147
• Status: Completed
• Phase: Phase 1
• Start date: August 9, 2019
• Est. completion date: September 18, 2020

Study information

• Verified date: September 2020
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 18, 2020
• Est. primary completion date: September 18, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Diagnostic Test:
• F-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.

Other:
• Blood draw
Collection of blood for research tests before the injection, 30, 60, 120 and 240 min after the injection.

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center