Back to results[18F]ISO-1 Positron Emission Tomography (PET/CT) in Primary Breast Cancer (ISO-1Primary)
Primary Purpose
Breast Cancer, Breast Neoplasm
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
[18F]ISO-1
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer
Eligibility Criteria
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.
Sites / Locations
- University of Pennsylvania Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ISO-1 PET/CT
Arm Description
All subjects will receive an [18F]ISO-1 PET/CT scan
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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
Evaluate the safety of [18F]ISO-1
Evaluate the safety of [18F]ISO-1
Correlate [18F]ISO-1 uptake with Autoradiography
Correlate [18F]ISO-1 uptake with Autoradiography
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
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)
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.)
Full Information
NCT ID
NCT02284919
First Posted
November 3, 2014
Last Updated
January 17, 2023
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT02284919
Brief Title
[18F]ISO-1 Positron Emission Tomography (PET/CT) in Primary Breast Cancer
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2014 (undefined)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Breast Neoplasm
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ISO-1 PET/CT
Arm Type
Experimental
Arm Description
All subjects will receive an [18F]ISO-1 PET/CT scan
Intervention Type
Drug
Intervention Name(s)
[18F]ISO-1
Other Intervention Name(s)
N-(4-(6,7-dimethoxy-3,-4-dihydroisoquinolin-2(1H)-yl)butyl)-2-(2-[18F]-fluoroethoxy)-5- Methylbenzamide ([18F]ISO-1)
Intervention Description
[18F]ISO-1 PET/CT scan
Primary Outcome Measure Information:
Title
Correlate [18F]ISO-1 uptake with pathologic assays measuring cellular proliferation rates (e.g. Ki-67)
Description
Correlate [18F]ISO-1 uptake with pathologic assays measuring cellular proliferation rates (e.g. Ki-67)
Time Frame
6 years
Secondary Outcome Measure Information:
Title
Evaluate the feasibility of using [18F]ISO-1 to image sigma-2 receptor binding in breast cancer
Description
Evaluate the feasibility of using [18F]ISO-1 to image sigma-2 receptor binding in breast cancer
Time Frame
6 years
Title
Evaluate the safety of [18F]ISO-1
Description
Evaluate the safety of [18F]ISO-1
Time Frame
6 years
Title
Correlate [18F]ISO-1 uptake with Autoradiography
Description
Correlate [18F]ISO-1 uptake with Autoradiography
Time Frame
6 years
Title
Correlate [18F]ISO-1 uptake a with multi-gene expression assay, validated to predict recurrence
Description
Correlate [18F]ISO-1 uptake a with multi-gene expression assay, validated to predict recurrence
Time Frame
6 years
Title
Correlate [18F]ISO-1 uptake with outcomes (e.g. time to recurrence, progression free survival and overall survival)
Description
Correlate [18F]ISO-1 uptake with outcomes (e.g. time to recurrence, progression free survival and overall survival)
Time Frame
6 years
Title
Test the association of [18F]ISO-1 uptake with phenotypic breast cancer subtypes (e.g. HER2+, TN, ER/PR+, etc.)
Description
Test the association of [18F]ISO-1 uptake with phenotypic breast cancer subtypes (e.g. HER2+, TN, ER/PR+, etc.)
Time Frame
6 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth McDonald, MD, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Mankoff, MD, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31836680
Citation
McDonald ES, Doot RK, Young AJ, Schubert EK, Tchou J, Pryma DA, Farwell MD, Nayak A, Ziober A, Feldman MD, DeMichele A, Clark AS, Shah PD, Lee H, Carlin SD, Mach RH, Mankoff DA. Breast Cancer 18F-ISO-1 Uptake as a Marker of Proliferation Status. J Nucl Med. 2020 May;61(5):665-670. doi: 10.2967/jnumed.119.232363. Epub 2019 Dec 13.
Results Reference
derived
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[18F]ISO-1 Positron Emission Tomography (PET/CT) in Primary Breast Cancer
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