Actively Recruiting
Molecularly Targeted Theranostic Approach for the Detection and Treatment of Metastatic Carcinomas
Led by University of California, Davis · Updated on 2026-04-27
40
Participants Needed
1
Research Sites
300 weeks
Total Duration
On this page
Sponsors
U
University of California, Davis
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a Phase I study to evaluate the safety and efficacy of the \[68Ga\]Ga DOTA-5G and \[177Lu\]Lu DOTA-ABM-5G theranostics pair in patients with metastatic cancer.
CONDITIONS
Official Title
Molecularly Targeted Theranostic Approach for the Detection and Treatment of Metastatic Carcinomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and willingly sign informed consent
- Age 18 years or older
- Pathologically confirmed metastatic genitourinary, gastrointestinal, gynecologic breast, cervical, uterine, or head and neck cancers with measurable disease
- Documented disease progression after at least one prior FDA-approved systemic treatment
- Available archival tumor tissue, preferably from metastatic site
- Eastern Cooperative Oncology Group Performance Status 0 to 2
- Completed prior systemic therapy at least 2 weeks before PET scan with resolved toxicity except hair loss or sensory neuropathy
- Hematologic parameters: ANC ≥ 1000 cells/mm3, platelet count ≥ 100,000/mm3, hemoglobin ≥ 8 g/dL
- Blood chemistry within limits: AST, ALT, alkaline phosphatase ≤ 5 times ULN; total bilirubin ≤ 2 times ULN; creatinine ≤ 2 times ULN
- Expected life expectancy of at least 3 months
- Ability to remain still for 30-60 minutes per scan
- For therapy: completed PET study and scan
- Presence of at least one measurable lesion on PET/CT with SUVmax > 2-fold above normal relevant tissues
You will not qualify if you...
- Class 3 or 4 congestive heart failure
- Significant bleeding within 2 weeks before enrollment
- Pregnant or lactating women
- Major surgery within 28 days before study or planned within 6 weeks
- Additional active malignancy requiring treatment within past 2 years except certain skin and in situ cancers
- Active uncontrolled infections despite treatment
- Psychiatric or social issues interfering with study compliance
- Cannot undergo PET/CT or SPECT/CT due to weight limits (over 350 lbs.)
- Pathologically confirmed non-small cell lung cancer with metastases
- INR > 2.0 or PTT > 15 seconds above normal
- Use of therapeutic warfarin anticoagulation
- Radiation or radiopharmaceutical treatment within 21 days before study start
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
Research Team
J
Julie L Sutcliffe, Phd
CONTACT
J
Julie L Sutcliffe
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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