Brain Neoplasms, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Metastases, Neoplasm
Conditions
Keywords
Lung Cancer, Metastatic Brain Cancer
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.
Interventions
DRUG111In-DAC
PROCEDUREDiagnostic
Sponsors
Copharos
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Countries
United States
Outcome results
None listed