This trial is active, not recruiting.

Conditions lung neoplasms, carcinoma, non-small-cell lung, brain neoplasms, metastases, neoplasm
Treatments 111in-dac, diagnostic
Phase phase 1
Sponsor Copharos
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

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic

Eligibility Criteria

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

Trial information was received from ClinicalTrials.gov and was last updated in June 2005.
Information provided to ClinicalTrials.gov by Copharos.