Status:
ACTIVE_NOT_RECRUITING
[18F]ISO-1 Positron Emission Tomography (PET/CT) in Primary Breast Cancer
Lead Sponsor:
University of Pennsylvania
Conditions:
Breast Cancer
Breast Neoplasm
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
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-...
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 popul...
Eligibility Criteria
Inclusion
- Adult patients, 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)
- 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
- 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 procedure 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.
Key Trial Info
Start Date :
March 11 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02284919
Start Date
March 11 2015
End Date
November 1 2026
Last Update
January 9 2026
Active Locations (1)
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1
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19104