Fluciclovine and PSMA PET/CT for the Classification and Improved Staging of Invasive Lobular Breast Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
PRIMARY OBJECTIVES:
-
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.
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Determine concordance and discordance of invasive lobular breast cancer (ILC) detection with PSMA versus fluciclovine PET, as confirmed with histology.
EXPLORATORY OBJECTIVE:
- 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Procedure: Computed Tomography
Undergo PET/CT scan
Other Names:
Drug: Fluciclovine F18
Given IV
Other Names:
Drug: Gallium Ga 68 Gozetotide
Given IV
Other Names:
Procedure: Positron Emission Tomography
Undergo PET/CT scan
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Verified detection rate for metastasis [Up to 5 years]
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.
- Verified detection rate for invasive lobular breast cancer [Up to 5 years]
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.
Other Outcome Measures
- Presence or absence of metastasis [Up to 5 years]
Will correlate circulating tumor deoxyribonucleic acid (ctDNA) results with the presence or absence of metastasis. ctDNA parameters will be summarized descriptively using mean, median, minimum/maximum, interquartile range, and standard deviation. ctDNA will be correlated with positron emission tomography uptake parameters using Pearson's or Spearman's correlation coefficient (where appropriate), as well as chi-squared tests, Fisher's exact tests, or analysis of variance if any variables are further categorized
- Imaging results [Up to 5 years]
Will correlate ctDNA results with the results of imaging.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Treatment naive biopsy proven ILC patients with ILC
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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
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Ability and willingness to undergo biopsy if needed per standard of care for possible metastasis which could change therapy approach
Exclusion Criteria:
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Pregnancy. Qualitative or quantitative serum or urine pregnancy test will be done in women of childbearing potential within 24 hours before PET
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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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | United States | 30322 |
Sponsors and Collaborators
- Emory University
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: David M Schuster, MD, Emory University Hospital/Winship Cancer Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00000675
- NCI-2020-00366
- WINSHIP4933-19
- P30CA138292