[68Ga]Ga DOTA-5G as a Diagnostic Imaging Agent for Metastatic/Advanced Invasive Lobular Breast Cancer (LBC)

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a study on Breast Cancer

Summary

Eligibility
for people ages 18-89 (full criteria)
Location
at Sacramento, California
Dates
study started
study ends around
Principal Investigator
by Julie Sutcliffe, PhD

Description

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).

Details

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.

Keywords

Metastatic Lobular Breast Carcinoma, Lobular Carcinoma, [68Ga]Ga DOTA-5G, [68Ga]Ga-DOTA-5G PET/CT imaging

Eligibility

You can join if…

Open to people ages 18-89

  • (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.

You CAN'T join if...

  • 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)

Location

  • University of California Davis accepting new patients
    Sacramento California 95817 United States

Lead Scientist at UC Davis

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
Links
Sign up for this study
ID
NCT07020806
Phase
Phase 1 Breast Cancer Research Study
Study Type
Interventional
Participants
Expecting 30 study participants
Last Updated
Contact us about this trial