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

NCT04750473 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-01-17

Study results available
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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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • National Institutes of Health (NIH)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • David M Schuster, MD · Emory University Hospital/Winship Cancer Institute

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-16
Primary Completion
2023-03-21
Completion
2024-03-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04750473 on ClinicalTrials.gov