Study of 111In-DAC as an Medical Imaging Agent for Lung Cancer and Brain Cancer Consistent With Metastatic Lung Cancer
This trial is active, not recruiting.
|Conditions||lung neoplasms, carcinoma, non-small-cell lung, brain neoplasms, metastases, neoplasm|
|Trial identifier||NCT00040560, CP102|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Male or female participants at least 18 years old.
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
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