Fluciclovine and PSMA PET/CT for the Classification and Improved Staging of Invasive Lobular Breast Cancer
NCT ID: NCT04750473
Last Updated: 2025-01-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2021-07-16
2024-03-21
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (Ga PSMA, fluciclovine F18, PET/CT)
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.
Computed Tomography
Undergo PET/CT scan
Fluciclovine F18
Given IV
Gallium Ga 68 Gozetotide
Given IV
Positron Emission Tomography
Undergo PET/CT scan
Interventions
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Computed Tomography
Undergo PET/CT scan
Fluciclovine F18
Given IV
Gallium Ga 68 Gozetotide
Given IV
Positron Emission Tomography
Undergo PET/CT scan
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
National Institutes of Health (NIH)
NIH
Emory University
OTHER
Responsible Party
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David M Schuster
Principal Investigator
Principal Investigators
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David M Schuster, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University Hospital/Winship Cancer Institute
Locations
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Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Countries
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References
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Mushtaq A, Lawal IO, Muzahir S, Friend SC, Bhave M, Meisel JL, Torres MA, Styblo TM, Graham CL, Kalinsky K, Switchenko J, Ulaner GA, Schuster DM. Prospective investigation of amino acid transport and PSMA-targeted positron emission tomography for metastatic lobular breast carcinoma. Eur J Nucl Med Mol Imaging. 2024 Nov;51(13):4073-4082. doi: 10.1007/s00259-024-06830-7. Epub 2024 Jul 8.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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NCI-2020-00366
Identifier Type: REGISTRY
Identifier Source: secondary_id
WINSHIP4933-19
Identifier Type: OTHER
Identifier Source: secondary_id
STUDY00000675
Identifier Type: -
Identifier Source: org_study_id
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