68Ga DOTA-5G PET/CT imaging for metastatic invasive lobular breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective Phase I investigator-initiated imaging study enrolling 30 patients with metastatic or advanced invasive lobular breast cancer over 24 months. Participants will undergo PET/CT imaging with 68Ga DOTA-5G, with comparisons made to standard 18F-FDG PET/CT to compare lesion detection. The study will monitor safety and tolerability of the tracer and record imaging sensitivity against RECIST or PERCIST-measurable disease. Eligibility requires measurable metastatic disease, available archival tumor tissue, ECOG ≤2, and basic hematologic and renal function criteria.

Why it matters

Who can join: the full rules

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)

Where it's running

• University of California Davis
  Sacramento, California, United States Recruiting

Study contacts

• Principal investigator: Julie Sutcliffe, PhD — University of California, Davis
• Study coordinator: Julie Sutcliffe, PhD
• Email: jlsutcliffe@health.ucdavis.edu
• Phone: 916-734-5536

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• FES-PET/MRI to tailor treatment for Luminal A and ER-positive lobular breast cancer

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• Registry for patients with metastatic lobular breast cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.