Study of 111In-DAC as an Medical Imaging Agent for Lung Cancer and Brain Cancer Consistent With Metastatic Lung Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Copharos

Criteria

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