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

Sponsor

Copharos (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00040560

Collaborator

(none)

Locations

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Brain Neoplasms Metastases, Neoplasm	Drug: 111In-DAC Procedure: Diagnostic	Phase 1

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Sutter Roseville Medical Center	Roseville	California	United States	95661
2	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida	United States	33612