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

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ClinicalTrials.gov Identifier: NCT02762110
Recruitment Status : Recruiting
First Posted : May 4, 2016
Last Update Posted : May 10, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Evaluate the feasibility of using a novel imaging test, [18F]ISO-1 PET/CT to image sigma-2 receptor binding in cancer. Correlate uptake with standard and experimental pathology assays of biopsy or surgical tissue. The target population is up to 30 adult patients at least 18 years, with a known or suspected breast cancer and at least one lesion 1.0 cm in size by at least one type of standard imaging.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: N-(4-(6,7-dimethoxy-3,-4-dihydroisoquinolin-2(1H)-yl)butyl)-2-(2-[18F]- fluoroethoxy)-5-methylbenzamide (18F-3c) ([18F]ISO-1) Radiation: Positron emission tomography (PET/CT) imaging Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
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 : October 2014
Estimated Primary Completion Date : October 2017

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U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: 2 years ]

Eligibility Criteria

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:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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). Only one type of imaging is required to show a lesion of 1 cm or greater in order for the patient to be eligible to participate in this study. Patients that have a prior diagnosis of primary breast cancer in the opposite breast can be included.
  • 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 procedures, 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. Only individuals (aged 18 or over) who can understand and give informed consent will be approached to participate in this study. Individuals who are considered to be mentally disabled will not be recruited for this study. All subjects must understand and be able to give informed consent. The investigators will not be using specific methods to assess decisional capacity. Economically disadvantaged persons will not be vulnerable to undue influence, as this study offers no compensation. All individuals will be told that their choice regarding study participation will in no way change their access to clinical care. This should negate any undue influence or coercion. Children, fetuses, neonates, or prisoners are not included in this research study. The menopausal status of the study participant will be reviewed during the screening process by examining the patient's chart, women of childbearing potential will have a serum or urine pregnancy test at the time of screening.
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): NCT02762110


Contacts
Contact: Elizabeth MacDonald, MD, PhD 855-216-0098 PennCancerTrials@emergingmed.com

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Elizabeth McDonald, MD, PhD    855-216-0098    PennCancerTrials@emergingmed.com   
Principal Investigator: Elizabeth McDonald, MD, PhD         
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
Principal Investigator: Elizabeth McDonald, MD, PhD Abramson Cancer Center of the University of Pennsylvania
More Information

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02762110     History of Changes
Other Study ID Numbers: UPCC 18114
First Posted: May 4, 2016    Key Record Dates
Last Update Posted: May 10, 2016
Last Verified: May 2016

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