Clincosm LogoSign in Get a demo

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

Sponsor
University of Pennsylvania (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02284919
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
108
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Imaging of In Vivo Sigma-2 Receptor Expression With [18F]ISO-1 Positron Emission Tomography (PET/CT) in Primary Breast Cancer
Study Start Date :
Nov 1, 2014
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: ISO-1 PET/CT

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

Drug: [18F]ISO-1
[18F]ISO-1 PET/CT scan
Other Names:
  • N-(4-(6,7-dimethoxy-3,-4-dihydroisoquinolin-2(1H)-yl)butyl)-2-(2-[18F]-fluoroethoxy)-5- Methylbenzamide ([18F]ISO-1)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. Evaluate the safety of [18F]ISO-1 [6 years]

      Evaluate the safety of [18F]ISO-1

    3. Correlate [18F]ISO-1 uptake with Autoradiography [6 years]

      Correlate [18F]ISO-1 uptake with Autoradiography

    4. 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

    5. 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)

    6. 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.)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Pennsylvania Hospital Philadelphia Pennsylvania United States 19104

    Sponsors and Collaborators

    • University of Pennsylvania

    Investigators

    • Principal Investigator: Elizabeth McDonald, MD, PhD, University of Pennsylvania
    • Principal Investigator: David Mankoff, MD, PhD, University of Pennsylvania

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Pennsylvania
    ClinicalTrials.gov Identifier:
    NCT02284919
    Other Study ID Numbers:
    • 820737
    • NCT02762110
    First Posted:
    Nov 6, 2014
    Last Update Posted:
    Aug 15, 2022
    Last Verified:
    Aug 1, 2022
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Aug 15, 2022