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Phase 1
18 Years
Open (Enrolling)
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Brain Neoplasms, Metastases, Neoplasm

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Trial Information

Inclusion 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

- Are taking or have taken part in any investigational study within 30 days of start of

- 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

Type of Study:


Study Design:

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


United States: Food and Drug Administration

Study ID:




Start Date:

Completion Date:

Related Keywords:

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



H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Sutter Roseville Medical Center Roseville, California  95661