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

NCT00040560 | Unknown Phase 1

• 1 other identifier: CP102
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Brain Neoplasms; Metastases, Neoplasm

Keywords

Lung Cancer; Metastatic Brain Cancer

Interventions

111In-DAC DRUG

Diagnostic PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Copharos: lead

Study Sites (2)

Sutter Roseville Medical Center

Roseville, California, 95661, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Brain Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 28, 2002
• First Posted: July 2, 2002
• Last Updated: June 24, 2005

Record last verified: 2003-01

Locations

US (2)