CClinicalTrials.gg
Status unknownNCT00040560Updated Jun 24, 2005

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

A Phase 1 interventional study of 111In-DAC and Diagnostic in Lung Neoplasms, Carcinoma, Non-Small-Cell Lung and Brain Neoplasms, sponsored by Copharos. Status unknown at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by Copharos · Phase 1, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jan 2003), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Lung Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Brain Neoplasms
  • Metastases, Neoplasm

Keywords

  • Lung Cancer
  • Metastatic Brain Cancer
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

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Lead sponsor

Copharos is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)

Interventions

  • Drug111In-DAC
  • ProcedureDiagnostic
06

Study locations

2 sites
  • Sutter Roseville Medical Center
    Roseville, California 95661, United States
  • H. Lee Moffitt Cancer Center and Research Institute
    Tampa, Florida 33612, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00040560
Lead sponsor
Copharos
First posted
Jul 2, 2002
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2003. You cannot join it, but the record below documents what was studied.

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