MedDataX Logo

[18F]ISO-1 Positron Emission Tomography (PET/CT) in Primary Breast Cancer

NCT ID: NCT02284919

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2025-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 population. \[18F\]ISO-1 uptake measures will be correlated with qualitative immunohistochemical staining for cell proliferation (Ki67). This is an observational study in that \[18F\]ISO-1 PET/CT will not be used to direct treatment decisions.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer Breast Neoplasm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ISO-1 PET/CT

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

Group Type EXPERIMENTAL

[18F]ISO-1

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

[18F]ISO-1

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

N-(4-(6,7-dimethoxy-3,-4-dihydroisoquinolin-2(1H)-yl)butyl)-2-(2-[18F]-fluoroethoxy)-5- Methylbenzamide ([18F]ISO-1)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Adult patients, at least 18 years of age
2. 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)
3. 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

1. 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.
2. Inability to tolerate imaging procedure in the opinion of an investigator or treating physician
3. 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.
4. Unwilling or unable to provide informed consent.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Elizabeth McDonald, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

David Mankoff, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 31836680 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

820737

Identifier Type: -

Identifier Source: org_study_id

NCT02762110

Identifier Type: -

Identifier Source: nct_alias