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| Name | Class |
|---|---|
| Dr. Helen K Chew, University of California Davis | UNKNOWN |
| Dr. Cameron Foster, University of California Davis | UNKNOWN |
| Society of Nuclear Medicine and Molecular Imaging | UNKNOWN |
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This is a prospective study using [68Ga]Ga DOTA-5G PET/CT imaging in patients diagnosed with metastatic/advanced invasive lobular breast cancer (LBC).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [68Ga]Ga-DOTA-5G PET/CT imaging | Experimental | Following an injection of up to 5 mCi of [68Ga]Ga DOTA-5G patients will be undergo PET/CT scans. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [68Ga]Ga DOTA-5G | Drug | Patients will be injected with up to 5 mCi of [68Ga]Ga DOTA-5G and imaged at 1 and 2 hours post injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The ability of [68Ga]Ga DOTA-5G PET/CT imaging to detect lesions | 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. | 2 hours from time of injection |
| Safety and tolerability of [68Ga]Ga DOTA-5G based on the incidence of adverse events using CTCAE v 5.0 | 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. | Up to 7 days from time of injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julie Sutcliffe, PhD | Contact | 916-734-5536 | jlsutcliffe@ucdavis.edu |
| Name | Affiliation | Role |
|---|---|---|
| Julie Sutcliffe, PhD | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Davis | Recruiting | Sacramento | California | 95817 | United States |
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| ID | Term |
|---|---|
| D018275 | Carcinoma, Lobular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| D009369 | Neoplasms |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |