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

Sponsored by:	Copharos
Information provided by:	Copharos
ClinicalTrials.gov Identifier:	NCT00040560

Purpose

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.

Condition	Intervention	Phase
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Brain Neoplasms Metastases, Neoplasm	Drug: 111In-DAC Procedure: Diagnostic	Phase I

MedlinePlus related topics: Brain Cancer Cancer Lung Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00040560

Locations

United States, California
Sutter Roseville Medical Center
Roseville, California, United States, 95661
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612

Sponsors and Collaborators

Copharos

More Information

No publications provided

Study ID Numbers:	CP102
Study First Received:	June 28, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00040560 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Copharos:

Lung Cancer
Metastatic Brain Cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Carcinoma
Brain Neoplasms
Respiratory Tract Diseases

Lung Neoplasms
Lung Diseases
Neoplasm Metastasis
Carcinoma, Non-Small-Cell Lung
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Nervous System Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Carcinoma
Brain Neoplasms
Neoplastic Processes

Neoplasms
Pathologic Processes
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasm Metastasis
Carcinoma, Non-Small-Cell Lung
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009