Metastatic Lobular Breast Carcinoma
Conditions
Brief summary
This is a prospective study using \[68Ga\]Ga DOTA-5G PET/CT imaging in patients diagnosed with metastatic/advanced invasive lobular breast cancer (LBC).
Detailed description
This is a phase I investigator-initiated study that will investigate \[68Ga\]Ga DOTA-5G in patients with metastatic/advanced invasive LBC. 30 patients diagnosed with LBC will be enrolled over a 24-month period. We hypothesize that a) \[68Ga\]Ga DOTA-5G will detect lesions in patients with invasive LBC, b) \[68Ga\]Ga DOTA-5G will be safe and well tolerated, and that c) \[68Ga\]Ga DOTA-5G PET/CT is more sensitive than 18F-FDG PET/CT at detecting lesions.
Interventions
DRUG[68Ga]Ga DOTA-5G
Patients will be injected with up to 5 mCi of \[68Ga\]Ga DOTA-5G and imaged at 1 and 2 hours post injection.
Sponsors
University of California, Davis
Dr. Helen K Chew, University of California Davis
Dr. Cameron Foster, University of California Davis
Society of Nuclear Medicine and Molecular Imaging
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* (Ability to understand and willingness to sign a written informed consent document. * Men and women age ≥ 18 yrs * Confirmed presence of metastatic/advanced invasive lobular breast cancer and measurable disease per RECIST (version 1.1) or PERCIST * Available archival tumor tissue * Eastern Cooperative Oncology Group Performance Status ≤ 2 * Hematologic parameters defined as: Absolute neutrophil count (ANC) ≥ 1000 cells/mm3,Platelet count ≥ 100,000/mm3, Hemoglobin ≥ 8 g/dL. * Blood chemistry levels defined as: AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN), Total bilirubin ≤ 2 times ULN, eGFR \>60 mL/min/1.73m\*2 * Anticipated life expectancy ≥ 3 months * Able to remain motionless for up to 30-60 minutes per scan.
Exclusion criteria
* Pregnant and lactating women * Prisoners * Concurrent malignancy of a different histology that could confound imaging interpretation. * Patients who cannot undergo PET/CT scanning because of weight limits(\>350lbs)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The ability of [68Ga]Ga DOTA-5G PET/CT imaging to detect lesions | 2 hours from time of injection | To assess the ability of \[68Ga\]Ga DOTA-5G PET/CT imaging to detect lesions. Following injection of \[68Ga\]Ga DOTA-5G patients will be imaged at 1 and 2 hours. Regions of interest will be drawn around lesions and standard uptake values (SUV) calculated. Detection of metastasis by \[68Ga\]Ga DOTA-5G PET/CT imaging, positive vs. negative based on if SUVmax \>2-fold above normal brain, bone, lung, or liver of \[68Ga\]Ga DOTA-5G in at least one lesion assessed by \[68Ga\]Ga DOTA-5G PET/CT and identified on \[18F\]-FDG PET/CT diagnostic imaging. |
| Safety and tolerability of [68Ga]Ga DOTA-5G based on the incidence of adverse events using CTCAE v 5.0 | Up to 7 days from time of injection | To evaluate the safety and tolerability of \[68Ga\]Ga DOTA-5G patients will be followed for up to 7 days for AEs using CTCAE v 5.0. |
Countries
United States
Contacts
CONTACTJulie Sutcliffe, PhD
PRINCIPAL_INVESTIGATORJulie Sutcliffe, PhD
University of California, Davis
Outcome results
None listed