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

a study on Breast Cancer

Summary

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

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)
  • 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, creatinine clearance >60 mL/min.
  • 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 5389489 California 5332921 95817 United States

Lead Scientist at University of California Health

  • Julie Sutcliffe, PhD (ucdavis)
    Professor, MED: Int Med Hematology/Oncology, School of Medicine. Authored (or co-authored) 66 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
ID
NCT07020806
Phase
Phase 1 Breast Cancer Research Study
Study Type
Interventional
Participants
Expecting 30 study participants
Last Updated