What side effects are associated with this type of intervention?

Common treatments for breast cancer include endocrine therapies like tamoxifen and aromatase inhibitors, chemotherapy, and radiation therapy. Tamoxifen can cause side effects such as hot flashes, increased risk of blood clots, and endometrial cancer. Aromatase inhibitors, like anastrozole, may lead to bone density loss, fractures, and cardiovascular issues. Chemotherapy often results in nausea, hair loss, fatigue, and increased infection risk. Radiation therapy can cause skin irritation, fatigue, and, in rare cases, heart or lung issues. Each treatment has a unique side effect profile that should be discussed with a healthcare provider.

What prior FDA approvals exist?

FDA-approved treatments for breast cancer include a variety of hormonal therapies, chemotherapies, and targeted therapies. Hormonal therapies such as tamoxifen and aromatase inhibitors (e.g., letrozole, anastrozole) are commonly used for hormone receptor-positive breast cancer. Chemotherapies like doxorubicin and cyclophosphamide are also standard treatments. Targeted therapies include HER2 inhibitors like trastuzumab and pertuzumab. While specific FDA approvals for sigma-2 receptor-targeting drugs like [18F]ISO-1 for imaging are not detailed, the landscape of breast cancer treatment is diverse, encompassing multiple modalities to address different cancer subtypes.

What other types of research exist?

Promising alternatives to [18F]ISO-1 for breast cancer imaging in 2024 include radiotracers targeting estrogen receptors, such as [18F]fluoroestradiol (FES), and other novel agents that bind to sigma receptors or AEBS ligands. Additionally, advancements in PET/CT imaging and the development of new radiotracers targeting specific cancer biomarkers may offer improved diagnostic capabilities.

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PET/CT Imaging for Breast Cancer (ISO-1Primary Trial)

Phase 1

Waitlist Available

Led By Elizabeth McDonald, 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

No Placebo-Only Group

Summary

This trial uses a new imaging method to detect specific features in breast cancer cells. It targets patients with primary breast cancer to see how well this method works and to ensure it is safe. The imaging substance helps make the cancer cells visible.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

Select...

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast cancer include endocrine therapy, chemotherapy, targeted therapy, and radiation therapy. Endocrine therapy works by blocking hormones like estrogen that fuel certain breast cancers. Chemotherapy targets rapidly dividing cancer cells, while targeted therapies, such as HER2 inhibitors, specifically attack cancer cells with certain genetic markers. Radiation therapy uses high-energy rays to destroy cancer cells. The investigational radiotracer [18F]ISO-1, which binds to sigma-2 receptors, is used in imaging to identify and evaluate the extent of breast cancer. Understanding these mechanisms helps tailor treatments to individual patients, improving efficacy and minimizing side effects.

Endocrine and targeted manipulation of breast cancer: summary statement for the Sixth Cambridge Conference.