Status:
COMPLETED
Fluciclovine and PSMA PET/CT for the Classification and Improved Staging of Invasive Lobular Breast Cancer
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Conditions:
Anatomic Stage IV Breast Cancer AJCC v8
Invasive Breast Lobular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 can...
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 confirme...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
July 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 21 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04750473
Start Date
July 16 2021
End Date
March 21 2024
Last Update
January 17 2025
Active Locations (1)
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1
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322