TheranosticTrials.org

Clinical Trial · NCT07915297

Safety and Biodistribution of [68Ga]Ga DOTA-5G in Subjects With Metastatic Breast Cancer (BC)

Overview

This is a prospective study using \[68Ga\]Ga DOTA-5G PET/CT imaging in patients diagnosed with metastatic breast cancer (BC).

Sponsor

Luminance Biosciences Inc

Phase

Phase 1

Contacts

Julie Sutcliffe (STUDY_DIRECTOR)

Julie Sutcliffe, Ph.D (CONTACT)

jlsutcliffe@luminancebio.com

5302048801

Zee Uys (CONTACT)

zee.ais-consulting@outlook.com

ClinicalTrials.gov

NCT07915297

Eligibility

Inclusion

  • Anticipated life expectancy ≥ 3 months
  • Hemoglobin ≥ 80 g/L.
  • Total bilirubin ≤ 2 times ULN,
  • Absolute neutrophil count (ANC) ≥ 1x 109 /L,
  • Confirmed presence of metastatic breast cancer
  • Creatinine ≤ 2 times ULN.
  • Blood chemistry levels defined as:
  • Platelet count ≥ 100x 109 /L,
  • Eastern Cooperative Oncology Group Performance Status ≤ 2
  • Hematologic parameters defined as:
  • AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN),
  • Able to remain motionless for up to 30-60 minutes per scan.

Exclusion

  • Prisoners
  • Pregnant and lactating women
  • Concurrent malignancy of a different histology that could confound imaging interpretation.
  • Patients who cannot undergo PET/CT scanning because of weight limits(\>450lbs)