RECRUITING

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

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Conditions

Metastatic Lobular Breast Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-06
Study Completion:2027-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07020806

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * (Ability to understand and willingness to sign a written informed consent document.
  2. * Men and women age ≥ 18 yrs
  3. * Confirmed presence of metastatic/advanced invasive lobular breast cancer and measurable disease per RECIST (version 1.1)
  4. * Available archival tumor tissue
  5. * Eastern Cooperative Oncology Group Performance Status ≤ 2
  6. * Hematologic parameters defined as: Absolute neutrophil count (ANC) ≥ 1000 cells/mm3,Platelet count ≥ 100,000/mm3, Hemoglobin ≥ 8 g/dL.
  7. * 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.
  8. * Anticipated life expectancy ≥ 3 months
  9. * Able to remain motionless for up to 30-60 minutes per scan.
  1. * Pregnant and lactating women
  2. * Prisoners
  3. * Concurrent malignancy of a different histology that could confound imaging interpretation.
  4. * Patients who cannot undergo PET/CT scanning because of weight limits(\>350lbs)

Contacts and Locations

Study Contact

Julie Sutcliffe, PhD
CONTACT
916-734-5536
jlsutcliffe@ucdavis.edu

Principal Investigator

Julie Sutcliffe, PhD
PRINCIPAL_INVESTIGATOR
University of California, Davis

Study Locations (Sites)

University of California Davis
Sacramento, California, 95817
United States

Collaborators and Investigators

Sponsor: University of California, Davis

  • Julie Sutcliffe, PhD, PRINCIPAL_INVESTIGATOR, University of California, Davis

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06
Study Completion Date2027-06

Study Record Updates

Study Start Date2025-06
Study Completion Date2027-06

Terms related to this study

Additional Relevant MeSH Terms

  • Metastatic Lobular Breast Carcinoma