What is the mechanism of action of this treatment?

Common treatments for breast cancer include hormone therapy, chemotherapy, targeted therapy, and immunotherapy. Hormone therapy, such as tamoxifen, blocks estrogen receptors on cancer cells, slowing their growth. Chemotherapy uses drugs to kill rapidly dividing cells, including cancer cells. Targeted therapies, like trastuzumab, specifically attack cancer cells with certain markers, such as HER2. Immunotherapy boosts the body's immune system to fight cancer. The [18F]F-GLN PET/CT trial focuses on imaging glutamine metabolism, which is crucial as cancer cells often have altered metabolism to support their rapid growth. Understanding these mechanisms helps tailor treatments to target specific pathways in breast cancer, potentially improving outcomes for patients.

What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as chemotherapy, anti-HER2 therapies, antihormonal treatments, and radiotherapy, are associated with a range of side effects. Chemotherapy can cause neutropenia, anemia, nausea, and peripheral neuropathy. Anti-HER2 therapies, like trastuzumab and pertuzumab, may lead to interstitial lung disease and cardiac issues. Antihormonal treatments, such as tamoxifen and aromatase inhibitors, can result in bone density loss, fractures, and cardiovascular risks. Radiotherapy is linked to acute toxicity, fatigue, and potential long-term cardiopulmonary issues.

What prior FDA approvals exist?

FDA-approved treatments for breast cancer include trastuzumab-emtansine (T-DM1) and fam-trastuzumab deruxtecan (T-DXd), both of which are used for HER2-positive breast cancer. These antibody-drug conjugates target the HER2 receptor, delivering cytotoxic agents directly to cancer cells. These treatments are similar to the investigational [18F]F-GLN PET/CT imaging, which focuses on metabolic processes in breast cancer, providing a comprehensive approach to targeting and visualizing cancer cells.

What other types of research exist?

Promising, novel alternatives to [18F]F-GLN PET/CT for breast cancer patients include [18F]Fluciclovine PET, which has potential as a pharmacodynamic biomarker of glutaminase inhibition, and integrated PET/MRI using advanced radiotracers like [18F]fluorodeoxyglucose (FDG) for staging and restaging. These alternatives offer enhanced imaging capabilities and may provide valuable insights for treatment planning and monitoring.

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[18F] F-GLN PET/CT Imaging for Breast Cancer ([18F]F-GLN Trial)

Phase 1

Recruiting

Led By Austin Pantel, MD

Research Sponsored by Abramson Cancer Center at Penn Medicine

Eligibility Criteria Checklist

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

Must have

Known or suspected primary or metastatic breast cancer

At least one lesion ≥ 1.5 cm that is seen on standard imaging (e.g. CT, MRI, mammogram, ultrasound, FDG-PET/CT). Only one type of imaging is required to show a lesion

Must not have

Females who are pregnant or breast feeding at the time of screening; a urine pregnancy test will be performed in women of child-bearing potential at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a special scan to see how a substance is absorbed by breast cancer cells in adults with significant lesions. The scan helps doctors understand the activity of the cancer by showing how much of the substance the cancer cells take up.

Who is the study for?

This trial is for adults with breast cancer who have at least one tumor that's 1.5 cm or larger, visible on standard imaging like CT, MRI, mammograms, etc. It's open to those with primary or metastatic breast cancer and requires participants to consent to its investigational nature. Pregnant or breastfeeding women and individuals unable to tolerate imaging procedures are excluded.

What is being tested?

[18F]F-GLN PET/CT scans are being tested in this observational study of up to 40 patients with different types of breast cancer. The scan involves an injection of [18F]F-GLN and aims to collect metabolism data and assess the uptake related to glutamine metabolism in tumors when tissue samples are available.

What are the potential side effects?

The safety profile of [18F]F-GLN will be monitored throughout the study; however, as it is a diagnostic agent rather than a therapeutic drug, fewer side effects are expected compared to treatment drugs. Any potential side effects from the injection or imaging process will be evaluated.

Eligibility Criteria

Inclusion Criteria

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

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I have or might have breast cancer that has spread.

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I have a tumor larger than 1.5 cm visible on an imaging test.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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

Kinetics and Biodistribution of [18F]F-GLN

Secondary study objectives

Association of Uptake with [18F]F-GLN

Association with Tumor Markers and [18F]F-GLN

Change in Uptake of [18F]F-GLN After Therapy

+2 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: UPTAKE OF [18F]F-GLN BY PET/CT IN BREAST CANCERExperimental Treatment1 Intervention

Pilot data will be collected to evaluate image quality and collect preliminary information on the uptake of \[18F\]F-Gln in breast cancer. Uptake measures will be compared to tumor markers of glutamine metabolism, when tissue is available. The safety of \[18F\]F-Gln will also be evaluated in all subjects.

0 / 4Eligibility 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 hormone therapy, chemotherapy, targeted therapy, and immunotherapy. Hormone therapy, such as tamoxifen, blocks estrogen receptors on cancer cells, slowing their growth. Chemotherapy uses drugs to kill rapidly dividing cells, including cancer cells. Targeted therapies, like trastuzumab, specifically attack cancer cells with certain markers, such as HER2. Immunotherapy boosts the body's immune system to fight cancer. The [18F]F-GLN PET/CT trial focuses on imaging glutamine metabolism, which is crucial as cancer cells often have altered metabolism to support their rapid growth. Understanding these mechanisms helps tailor treatments to target specific pathways in breast cancer, potentially improving outcomes for patients.