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[18F]ISO-1 for Breast Cancer (ISO-1Primary Trial)

Phase 1

Waitlist Available

Led By David Mankoff, MD, PhD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 years

Awards & highlights

ISO-1Primary Trial Summary

This trial will use PET/CT imaging to study sigma-2 receptor activity in primary breast cancer.

Who is the study for?

This trial is for adults over 18 with known or suspected breast cancer and at least one lesion larger than 1 cm. They must understand the study's experimental nature and give written consent. It excludes pregnant women, those unable to undergo imaging procedures, and individuals with serious medical or psychological conditions.Check my eligibility

What is being tested?

[18F]ISO-1 PET/CT scans are being tested to see how well they can detect sigma-2 receptor activity in primary breast cancer sites. This could help in assessing the tumor's characteristics using a new type of imaging tracer.See study design

What are the potential side effects?

Since this trial involves diagnostic imaging rather than drug treatment, side effects may include discomfort from lying still during the scan and exposure to a small amount of radiation typical for PET/CT scans.

ISO-1Primary Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have a breast lesion that is at least 1 cm big, confirmed by imaging.

ISO-1Primary Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

Correlate [18F]ISO-1 uptake with Autoradiography

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

+3 more

ISO-1Primary Trial Design

1Treatment groups

Experimental Treatment

Group I: ISO-1 PET/CTExperimental Treatment1 Intervention

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,002 Previous Clinical Trials

42,880,969 Total Patients Enrolled

27 Trials studying Breast Cancer

26,330 Patients Enrolled for Breast Cancer

David Mankoff, MD, PhDPrincipal InvestigatorUniversity of Pennsylvania

3 Previous Clinical Trials

100 Total Patients Enrolled

Elizabeth McDonald, MD, PhDPrincipal InvestigatorUniversity of Pennsylvania

Media Library

[18F]ISO-1 Clinical Trial Eligibility Overview. Trial Name: NCT02284919 — Phase 1

Breast Cancer Research Study Groups: ISO-1 PET/CT

Breast Cancer Clinical Trial 2023: [18F]ISO-1 Highlights & Side Effects. Trial Name: NCT02284919 — Phase 1

[18F]ISO-1 2023 Treatment Timeline for Medical Study. Trial Name: NCT02284919 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the population size involved in this research endeavor?

"Currently, this research project is not accepting any additional participants. According to the data posted on clinicaltrials.gov, it was first listed in November 2014 and most recently revised August 2022. Those seeking alternate studies may find there are 2602 trials searching for breast cancer patients and 1 trial looking for [18F]ISO-1 volunteers."

Answered by AI

Is this research endeavor looking for participants at the moment?

"Per the clinicaltrials.gov page, enrollment for this study is no longer active. It was initially listed on November 1st 2014 and last updated on August 11th 2022. Despite its inactivity, 2602 other medical trials are currently recruiting patients worldwide."

Answered by AI

What regulatory approval has [18F]ISO-1 achieved?

"Due to the experimental nature of [18F]ISO-1, and limited data regarding efficacy and safety, our team at Power have given it a rating of 1."

Answered by AI

Have there been any precedent occurrences of [18F]ISO-1 being employed in clinical trials?

"Presently, one clinical trial is being conducted to evaluate the effects of [18F]ISO-1. This medical experiment has progressed beyond Phase 2 and is taking place primarily in Philadelphia, Pennsylvania with a single additional site as well."

Answered by AI

Recent research and studies

Journal of Nuclear MedicineJournal

Breast Cancer <sup>18</sup>f-iso-1 Uptake as a Marker of Proliferation Status

McDonald, Elizabeth S., Robert K. Doot, Anthony J. Young, Erin K. Schubert, Julia Tchou, Daniel A. Pryma, Michael D. Farwell, et al.. 2019. “Breast Cancer 18f-iso-1 Uptake as a Marker of Proliferation Status”. Journal of Nuclear Medicine. Society of Nuclear Medicine. doi:10.2967/jnumed.119.232363.

clinicaltrials.govStudy

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

2014. "[18F]ISO-1 Positron Emission Tomography (PET/CT) in Primary Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02284919.