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

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. Read our disclaimer for details. Identifier: NCT02284919
Recruitment Status : Active, not recruiting
First Posted : November 6, 2014
Last Update Posted : December 11, 2018
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Breast Neoplasm Drug: [18F]ISO-1 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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 : November 2014
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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 identifier (NCT number): NCT02284919

United States, Pennsylvania
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Principal Investigator: Elizabeth McDonald, MD, PhD University of Pennsylvania
Principal Investigator: David Mankoff, MD, PhD University of Pennsylvania

Responsible Party: University of Pennsylvania Identifier: NCT02284919     History of Changes
Obsolete Identifiers: NCT02762110
Other Study ID Numbers: 820737
First Posted: November 6, 2014    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018

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