NCT04750473

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography	Undergo PET/CT scan
DRUG	Fluciclovine F18	Given IV
DRUG	Gallium Ga 68 Gozetotide	Given IV
PROCEDURE	Positron Emission Tomography	Undergo PET/CT scan

Timeline

• Start date: 2021-07-16
• Primary completion: 2023-03-21
• Completion: 2024-03-21
• First posted: 2021-02-11
• Last updated: 2025-01-17
• Results posted: 2025-01-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study