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

Phase 1

Active, not recruiting

• Conditions: Breast Cancer; Breast Neoplasm
• Interventions: Drug: [18F]ISO-1

• Registration Number: NCT02284919
• Lead Sponsor: University of Pennsylvania

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.

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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-03
• Study First Submitted QC: 2014-11-03
• Study First Posted: 2014-11-06
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-18
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

1. Adult patients, at least 18 years of age
2. 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)
3. 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

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Exclusion Criteria

1. 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.
2. Inability to tolerate imaging procedure in the opinion of an investigator or treating physician
3. 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.
4. Unwilling or unable to provide informed consent.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ISO-1 PET/CT	[18F]ISO-1	All subjects will receive an \[18F\]ISO-1 PET/CT scan

Primary Outcome Measures

Name	Time	Method
Correlate [18F]ISO-1 uptake with pathologic assays measuring cellular proliferation rates (e.g. Ki-67)	6 years	Correlate \[18F\]ISO-1 uptake with pathologic assays measuring cellular proliferation rates (e.g. Ki-67)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Pennsylvania Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States