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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2003 by Copharos. Recruitment status was Active, not recruiting

First Received on June 28, 2002. Last Updated on June 23, 2005 History of Changes

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by Copharos:

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

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

Keywords provided by Copharos:

Lung Cancer
Metastatic Brain Cancer

Additional relevant MeSH terms:

Brain Neoplasms
Neoplasms
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasm Metastasis
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases

Nervous System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on February 12, 2012