Fluciclovine and PSMA PET/CT for the Classification and Improved Staging of Invasive Lobular Breast Cancer

Study Overview
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Brief Summary
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This phase I trial studies how well fluciclovine positron emission tomography (PET)/computed tomography (CT) and PSMA PET/CT work in helping doctors understand and classify invasive lobular breast cancer in patients with invasive lobular breast cancer that is suspicious for or has spread to other places in the body (metastasized). Fluciclovine and PSMA are radiotracers used in PET/CT imaging scans that emit radiation. The PET/CT scan than picks up the radiation being released to create a picture from within the body. Information learned from this study may help researchers learn how to better identify metastatic disease in invasive lobular breast cancer patients which will impact appropriate staging.

Detailed Description
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PRIMARY OBJECTIVES: I. Improve detection of metastasis with fluciclovine F18 (fluciclovine) and gallium Ga 68-labeled PSMA-11 (PSMA) PET versus best standard of care conventional imaging, as confirmed with histology. II. Determine concordance and discordance of invasive lobular breast cancer (ILC) detection with PSMA versus fluciclovine PET, as confirmed with histology. EXPLORATORY OBJECTIVE: I. Establish the role of circulating tumor deoxyribonucleic acid (DNA) (ctDNA) directed to ESR1 and PI3K DNA in characterizing the degree of tumor burden as identified by metabolic amino acid transport and tumor neovasculature receptor imaging. OUTLINE: Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV) and undergo a PET/computed tomography (CT) scan over 30 minutes. On a separate day, patients receive fluciclovine F18 IV and undergo a PET/CT scan over 30 minutes. After completion of study, patients are followed up in 5-10 business days, and then up to 5 years.

Official Title
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Phase 1 Feasibility Trial: Improved Staging of Lobular Breast Cancer With Novel Amino Acid Metabolic and Tumor Neovasculature Receptor Imaging

Conditions
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Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Lobular Carcinoma, Metastatic Breast Lobular Carcinoma, Prognostic Stage IV Breast Cancer AJCC v8

Intervention / Treatment
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* Procedure: Computed Tomography
* Drug: Fluciclovine F18
* Drug: Gallium Ga 68 Gozetotide
* Procedure: Positron Emission Tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Treatment naive biopsy proven ILC patients with ILC Either: a) clinical or imaging suspicion of metastatic disease; or b) proven metastatic disease but in whom there is suspicion of an even greater tumor burden that could change therapy approach Ability and willingness to undergo biopsy if needed per standard of care for possible metastasis which could change therapy approach Exclusion Criteria: Pregnancy. Qualitative or quantitative serum or urine pregnancy test will be done in women of childbearing potential within 24 hours before PET A female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (if age > 55 years); if the female subject is < 55 years and she has been naturally postmenopausal for > 1 year her reproductive status has to be verified by additional lab tests (< 20 estradiol OR estradiol < 40 with follicle-stimulating hormone [FSH] > 40 in women not on estrogen replacement therapy)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (Ga PSMA, fluciclovine F18, PET/CT)<br>Patients receive gallium Ga 68-labeled PSMA-11 IV and undergo a PET/CT scan over 30 minutes. On a separate day, patients receive fluciclovine F18 IV and undergo a PET/CT scan over 30 minutes. | Procedure: Computed Tomography<br>* Undergo PET/CT scan<br>* Other names: tomography;Drug: Fluciclovine F18<br>* Given IV<br>* Other names: GE-148 F-18;Drug: Gallium Ga 68 Gozetotide<br>* Given IV<br>* Other names: PSMA-HBED-CC GA-68;Procedure: Positron Emission Tomography<br>* Undergo PET/CT scan<br>* Other names: proton magnetic resonance spectroscopic imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verified detection rate for metastasis | Detection rates are compared between fluciclovine positron emission tomography (PET) and conventional imaging. Paired detection rates will be assessed using McNemar's test. Detection rates will be reported for each method, and 95% confidence intervals will be estimated using the Clopper-Pearson approach. Rates of concordant/discordant observations will be reported. | Up to 5 years | 
| Verified detection rate for invasive lobular breast cancer | Compared between gallium Ga 68-labeled PSMA-11 PET, fluciclovine PET, and conventional imaging. Paired detection rates will be assessed using McNemar's test. Detection rates will be reported for each method, and 95% confidence intervals will be estimated using the Clopper-Pearson approach. Rates of concordant/discordant observations will be reported. | Up to 5 years |