NCT02284919

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 breast-cancer

Timeline
6mo left

Started Mar 2015

Longer than P75 for phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Mar 2015Nov 2026

First Submitted

Initial submission to the registry

November 3, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 6, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

March 11, 2015

Completed
11.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

11.7 years

First QC Date

November 3, 2014

Last Update Submit

January 7, 2026

Conditions

Breast CancerBreast Neoplasm

Outcome Measures

Primary Outcomes (1)

  • Correlate [18F]ISO-1 uptake with pathologic assays measuring cellular proliferation rates (e.g. Ki-67)

    Correlate \[18F\]ISO-1 uptake with pathologic assays measuring cellular proliferation rates (e.g. Ki-67)

    6 years

Secondary Outcomes (6)

  • Evaluate the feasibility of using [18F]ISO-1 to image sigma-2 receptor binding in breast cancer

    6 years

  • Evaluate the safety of [18F]ISO-1

    6 years

  • Correlate [18F]ISO-1 uptake with Autoradiography

    6 years

  • Correlate [18F]ISO-1 uptake a with multi-gene expression assay, validated to predict recurrence

    6 years

  • Correlate [18F]ISO-1 uptake with outcomes (e.g. time to recurrence, progression free survival and overall survival)

    6 years

  • +1 more secondary outcomes

Study Arms (1)

ISO-1 PET/CT

EXPERIMENTAL

All subjects will receive an \[18F\]ISO-1 PET/CT scan

Drug: [18F]ISO-1

Interventions

[18F]ISO-1DRUG

\[18F\]ISO-1 PET/CT scan

Also known as: N-(4-(6,7-dimethoxy-3,-4-dihydroisoquinolin-2(1H)-yl)butyl)-2-(2-[18F]-fluoroethoxy)-5- Methylbenzamide ([18F]ISO-1)
ISO-1 PET/CT

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • McDonald ES, Doot RK, Young AJ, Schubert EK, Tchou J, Pryma DA, Farwell MD, Nayak A, Ziober A, Feldman MD, DeMichele A, Clark AS, Shah PD, Lee H, Carlin SD, Mach RH, Mankoff DA. Breast Cancer 18F-ISO-1 Uptake as a Marker of Proliferation Status. J Nucl Med. 2020 May;61(5):665-670. doi: 10.2967/jnumed.119.232363. Epub 2019 Dec 13.

    PMID: 31836680DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Elizabeth McDonald, MD, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • David Mankoff, MD, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2014

First Posted

November 6, 2014

Study Start

March 11, 2015

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

January 9, 2026

Record last verified: 2026-01

Locations

US(1)