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

Breast Cancer Clinical Trial

— ISO-1Primary  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02284919
• Other study ID #: 820737
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: November 2014
• Est. completion date: November 2024

Study information

• Verified date: December 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT02762110

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasm
• Breast Neoplasms

Intervention

Drug:
• [18F]ISO-1
[18F]ISO-1 PET/CT scan

Locations

Country	Name	City	State
United States	University of Pennsylvania Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Evaluate the safety of [18F]ISO-1	Evaluate the safety of [18F]ISO-1	6 years
Secondary	Correlate [18F]ISO-1 uptake with Autoradiography	Correlate [18F]ISO-1 uptake with Autoradiography	6 years
Secondary	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
Secondary	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
Secondary	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