Recruiting
Phase 1

DOTA-5G PET/CT

Sponsor:

UCLA

Code:

NCT07020806

Conditions

Metastatic Lobular Breast Carcinoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

[68Ga]Ga DOTA-5G

Study Details

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).

Conditions

Metastatic Lobular Breast Carcinoma

Study ID

NCT07020806

Start date

Nov 18, 2025

Status verified date

Feb, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: [68Ga]Ga-DOTA-5G PET/CT imaging

Following an injection of up to 5 mCi of \[68Ga\]Ga DOTA-5G patients will be undergo PET/CT scans.

Interventions

[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.

Primary outcome measure

  • The ability of [68Ga]Ga DOTA-5G PET/CT imaging to detect lesions [ Time Frame: 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 [ Time Frame: Up to 7 days from time of injection ]

Central Contacts and Locations

Central contacts

Julie Sutcliffe, PhD

916-734-5536jlsutcliffe@ucdavis.edu

Locations

University of California Davis

Recruiting

Sacramento, California, United States, 95817

Contacts

Julie L Sutcliffe

9167345536jlsutcliffe@ucdavis.edu

Principal Investigator:

Julie Sutcliffe

More Information

Sponsor

University of California, Davis

Last update posted

Mar 23, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-03-23.