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
4 other identifiers
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jul 2021
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2021
CompletedFirst Posted
Study publicly available on registry
February 11, 2021
CompletedStudy Start
First participant enrolled
July 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2024
CompletedResults Posted
Study results publicly available
January 17, 2025
CompletedJanuary 17, 2025
January 1, 2025
1.7 years
February 9, 2021
November 21, 2024
January 15, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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 105 days
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 105 days
Study Arms (1)
Diagnostic (Ga PSMA, fluciclovine F18, PET/CT)
EXPERIMENTALPatients 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.
Interventions
Undergo PET/CT scan
Given IV
Given IV
Undergo PET/CT scan
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
- National Cancer Institute (NCI)collaborator
- National Institutes of Health (NIH)collaborator
Study Sites (1)
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Related Publications (1)
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.
PMID: 38976035DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. David Schuster
- Organization
- Emory University/Winship Cancer Institute
Study Officials
- PRINCIPAL INVESTIGATOR
David M Schuster, MD
Emory University Hospital/Winship Cancer Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 9, 2021
First Posted
February 11, 2021
Study Start
July 16, 2021
Primary Completion
March 21, 2023
Study Completion
March 21, 2024
Last Updated
January 17, 2025
Results First Posted
January 17, 2025
Record last verified: 2025-01