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

  • STATUS
    Recruiting
  • participants needed
    30
  • sponsor
    Abramson Cancer Center of the University of Pennsylvania
Updated on 8 November 2020
mammogram
magnetic resonance imaging of breast

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.

Details
Condition Breast Cancer
Treatment N-(4-(6,7-dimethoxy-3,-4-dihydroisoquinolin-2(1H)-yl)butyl)-2-(2-[18F]- fluoroethoxy)-5-methylbenzamide (18F-3c) ([18F]ISO-1), Positron emission tomography (PET/CT) imaging
Clinical Study IdentifierNCT02762110
SponsorAbramson Cancer Center of the University of Pennsylvania
Last Modified on8 November 2020

Eligibility

Yes No Not Sure

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
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