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

Status
Active
Cancer Type
Breast Cancer
Unknown Primary
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Diagnostic
NCT ID
NCT04750473
Protocol IDs
WINSHIP4933-19 (primary)
NCI-2020-00366
Study Sponsor
Emory University Hospital/Winship Cancer Institute

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.

Objectives

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 molecular detection by circulating tumor deoxyribonucleic acid (ctDNA) mutations including PIK3CA, ESR1, HER2, and AKT1 in characterizing the degree of tumor burden as identified by metabolic amino acid transport and/or 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.

Eligibility

  1. Biopsy proven patients with ILC not currently on systemic treatment (> 4 weeks)
  2. 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
  3. Ability and willingness to undergo biopsy if needed per standard of care for possible metastasis which could change therapy approach
  4. Age over 18
  5. Non-English-speaking patients may be considered for enrollment in this trial. Subjects with Limited English Proficiency LEP may be enrolled and study team members will use Emory Institutional Review Board (IRB) approved short forms to conduct the consent process
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.