Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Lobular Carcinoma, Metastatic Breast Lobular Carcinoma, Prognostic Stage IV Breast Cancer AJCC v8
Conditions
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.
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 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.
Interventions
PROCEDUREComputed Tomography
Undergo PET/CT scan
DRUGFluciclovine F18
Given IV
Given IV
PROCEDUREPositron Emission Tomography
Undergo PET/CT scan
Sponsors
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Emory University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Verified Detection Rate for Metastasis | Up to 105 days | 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 105 days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Diagnostic (Ga PSMA, Fluciclovine F18, PET/CT) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Region of Enrollment United States | 20 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
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.
Time frame: Up to 105 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| F-Fluciclovine | Verified Detection Rate for Invasive Lobular Breast Cancer | 7.8 SUVMax |
| Ga-PSMA-11 | Verified Detection Rate for Invasive Lobular Breast Cancer | 4.6 SUVMax |
Primary
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.
Time frame: Up to 105 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| F-Fluciclovine | Verified Detection Rate for Metastasis | 5.9 SUVMax |
| Ga-PSMA-11 | Verified Detection Rate for Metastasis | 5.5 SUVMax |