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
Recruitment status was Active, not recruiting
Sponsor:
Copharos
Information provided by:
Copharos
ClinicalTrials.gov Identifier:
NCT00040560
First received: June 28, 2002
Last updated: June 23, 2005
Last verified: January 2003
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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 1 |
| 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:
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 May 23, 2013