Active, not recruiting • Phase I • Stage 0, I, II, III, IV • Post-Menopausal • Interventional

The following is imported from ClinicalTrials.gov:

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

Brief 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.

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.

Study Design

Eligibility Criteria

Arms and Intervention

• [18F]ISO-1

Inclusion criteria

• adult patients, at least 18 years of age

• known or suspected breast cancer with at least one breast lesion that is 1 cm or greater in size by standard imaging (e.g. mammography, ultrasound or breast mri)

• participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures

Exclusion criteria

• females who are pregnant at the time of screening will not be eligible for this study, urine or serum pregnancy test will be performed in women of child-bearing potential at the time of screening.

• inability to tolerate imaging procedure in the opinion of an investigator or treating physician

• serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.

• unwilling or unable to provide informed consent.