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[18F]ISO-1 PET/CT in Breast Cancer

This study is currently recruiting participants.
Verified October 2017 by University of Pennsylvania
Sponsor:
ClinicalTrials.gov Identifier:
NCT02284919
First Posted: November 6, 2014
Last Update Posted: October 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Pennsylvania
  Purpose
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 Intervention Phase
Breast Cancer Breast Neoplasm Drug: [18F]ISO-1 Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Correlate [18F]ISO-1 uptake with pathologic assays measuring cellular proliferation rates (e.g. Ki-67) [ Time Frame: 2 years ]

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

Estimated Enrollment: 30
Study Start Date: November 2014
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02284919


Contacts
Contact: Karen Palmer 215-746-2813 Karen.Palmer@uphs.upenn.edu
Contact: Erin Schubert 215-573-6569 Erin.Schubert@uphs.upenn.edu

Locations
United States, Pennsylvania
University of Pennsylvania Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Karen Palmer    215-746-2813    karen.palmer@uphs.upenn.edu   
Contact: Erin Schubert    215-573-6569    erin.schubert@uphs.upenn.edu   
Principal Investigator: Elizabeth McDonald, MD, PhD         
Principal Investigator: David Mankoff, MD, PHD         
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
  More Information

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02284919     History of Changes
Other Study ID Numbers: 820737
First Submitted: November 3, 2014
First Posted: November 6, 2014
Last Update Posted: October 4, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases