NCT02284919

[18F]ISO-1 Positron Emission Tomography (PET/CT) in Primary Breast Cancer

Imaging of In Vivo Sigma-2 Receptor Expression With [18F]ISO-1 Positron Emission Tomography (PET/CT) in Primary Breast Cancer

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this study, positron emission tomography (PET/CT) imaging will be used to evaluate sigma-2 (σ2) receptor activity in sites of primary breast cancer using the investigational radiotracer \[18F\]ISO-1.

Detailed description

This study will evaluate the feasibility of using \[18F\]ISO-1 PET/CT to image sigma-2 receptor binding in primary breast tumors and continue to evaluate the safety of the tracer in this patient population. \[18F\]ISO-1 uptake measures will be correlated with qualitative immunohistochemical staining for cell proliferation (Ki67). This is an observational study in that \[18F\]ISO-1 PET/CT will not be used to direct treatment decisions.

Conditions

• Breast Cancer
• Breast Neoplasm

Interventions

Type	Name	Description
DRUG	[18F]ISO-1	\[18F\]ISO-1 PET/CT scan

Timeline

• Start date: 2015-03-11
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2014-11-06
• Last updated: 2026-01-09

Locations

1 site across 1 country: United States