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

Primary Purpose

Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Brain Neoplasms

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
111In-DAC
Diagnostic
Sponsored by
Copharos
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Neoplasms focused on measuring Lung Cancer, Metastatic Brain Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Sutter Roseville Medical Center
  • H. Lee Moffitt Cancer Center and Research Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 28, 2002
Last Updated
June 23, 2005
Sponsor
Copharos
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1. Study Identification

Unique Protocol Identification Number
NCT00040560
Brief Title
Study of 111In-DAC as an Medical Imaging Agent for Lung Cancer and Brain Cancer Consistent With Metastatic Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2003
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Copharos

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Brain Neoplasms, Metastases, Neoplasm
Keywords
Lung Cancer, Metastatic Brain Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
111In-DAC
Intervention Type
Procedure
Intervention Name(s)
Diagnostic

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Sutter Roseville Medical Center
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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