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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02762110
• Other study ID #: UPCC 18114
• Status: Recruiting
• Phase: Phase 1
• Start date: October 2014

Study information

• Verified date: September 2018
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: Elizabeth MacDonald, MD, PhD
• Phone: 855-216-0098
• Email: PennCancerTrials[@]emergingmed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events		2 years