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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer, Breast Neoplasm

Intervention / Treatment
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* Drug: [18F]ISO-1


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ISO-1 PET/CT<br>All subjects will receive an [18F]ISO-1 PET/CT scan | Drug: [18F]ISO-1<br>* [18F]ISO-1 PET/CT scan<br>* Other names: N-(4-(6,7-dimethoxy-3,-4-dihydroisoquinolin-2(1H)-yl)butyl)-2-(2-[18F]-fluoroethoxy)-5- Methylbenzamide ([18F]ISO-1);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlate [18F]ISO-1 uptake with pathologic assays measuring cellular proliferation rates (e.g. Ki-67) | Correlate [18F]ISO-1 uptake with pathologic assays measuring cellular proliferation rates (e.g. Ki-67) | 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the feasibility of using [18F]ISO-1 to image sigma-2 receptor binding in breast cancer | Evaluate the feasibility of using [18F]ISO-1 to image sigma-2 receptor binding in breast cancer | 6 years | 
| Evaluate the safety of [18F]ISO-1 | Evaluate the safety of [18F]ISO-1 | 6 years | 
| Correlate [18F]ISO-1 uptake with Autoradiography | Correlate [18F]ISO-1 uptake with Autoradiography | 6 years | 
| Correlate [18F]ISO-1 uptake a with multi-gene expression assay, validated to predict recurrence | Correlate [18F]ISO-1 uptake a with multi-gene expression assay, validated to predict recurrence | 6 years | 
| Correlate [18F]ISO-1 uptake with outcomes (e.g. time to recurrence, progression free survival and overall survival) | Correlate [18F]ISO-1 uptake with outcomes (e.g. time to recurrence, progression free survival and overall survival) | 6 years | 
| Test the association of [18F]ISO-1 uptake with phenotypic breast cancer subtypes (e.g. HER2+, TN, ER/PR+, etc.) | Test the association of [18F]ISO-1 uptake with phenotypic breast cancer subtypes (e.g. HER2+, TN, ER/PR+, etc.) | 6 years |