NCT00040560UnknownPhase 1
Study of 111In-DAC as an Medical Imaging Agent for Lung Cancer and Brain Cancer Consistent With Metastatic Lung Cancer
Copharos2 sites in 1 countryStarted: July 2, 2002Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Locations
- 2
Study Overview
Brief Summary
The purpose of this study is to investigate the safety and imaging ability of 111In-DAC when used with planar and SPECT imaging for the detection of lung cancer and brain cancer consistent with metastatic lung cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients will be eligible for the study if they:
- •Are male or non-pregnant, non-lactating females 18 years of age or older (must agree to use an appropriate and effective method of birth control during the study and for 2 weeks after study)
- •Have an ECOG performance status of Zero or One
- •Are being evaluated for known or suspected non-small-cell lung cancer (NSCLC), or known brain lesions consistent with metastatic lung cancer
- •(For NSCLC patients)Have been previously scheduled for biopsy or surgical excision of the suspected NSCLC, or have a pathological diagnosis of lung cancer within 2 months of enrollment but have received no previous treatment
- •(For brain cancer patients) Have clinical signs and symptoms consistent with a primary NSCLC with histological or cytopathological confirmation. Patients cannot have received previous treatment with radiation to the brain.
- •Have signed an informed consent form
Exclusion Criteria
- •Patients will not be eligible for this study if they:
- •Have a history or suspicion of significant allergic reaction or anaphylaxis to any of the 111In-DAC components
- •Have a clinically unstable medical condition or opportunistic infection, a life-threatening disease state, impaired renal or hepatic function or are immunosuppressed
- •Are taking or have taken part in any investigational study within 30 days of start of study
- •Have received an indium agent within 30 days of start of study
- •Are not able to remain immobile during scanning time
- •Have taken drugs that may damage the kidneys within 2 weeks of start of study
- •Have abnormal laboratory test results: hemoglobin<9.5 gms/dl, serum creatinine>1.5mg/100ml, alkaline phosphatase 2X the upper limit of normal
- •Have undergone an excisional and/or needle localization biopsy within 4 days prior to study drug administration
- •Have undergone a PET scan within 7 days prior to study drug administration
- •Have any active or previously treated second malignancy except carcinoma in situ of the uterine cervix or non-melanoma skin cancer
Investigators
Study Sites (2)
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