NCT07020806

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
13mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Nov 2025Jun 2027

First Submitted

Initial submission to the registry

May 21, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 13, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

November 18, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

March 23, 2026

Status Verified

February 1, 2026

Enrollment Period

1.5 years

First QC Date

May 21, 2025

Last Update Submit

March 19, 2026

Conditions

Metastatic Lobular Breast Carcinoma

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

[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.

Drug: [68Ga]Ga DOTA-5G

Interventions

[68Ga]Ga DOTA-5GDRUG

Patients will be injected with up to 5 mCi of \[68Ga\]Ga DOTA-5G and imaged at 1 and 2 hours post injection.

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

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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 may not qualify 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Davis

Sacramento, California, 95817, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Lobular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Ductal, Lobular, and MedullaryBreast NeoplasmsNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Julie Sutcliffe, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Sutcliffe, PhD

CONTACT

916-734-5536jlsutcliffe@ucdavis.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 21, 2025

First Posted

June 13, 2025

Study Start

November 18, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

March 23, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)