FEASIBILITY OF THE LUM IMAGING SYSTEM FOR IN VIVO AND EX VIVO DETECTION OF CANCER IN SUBJECTS WITH LOW GRADE GLIOMAS, GLIOBLASTOMAS AND CANCER METASTASES TO THE BRAIN
The overall objective of this study is to assess the safety and efficacy of the LUM Imaging
System in imaging primary and metastatic cancer in the brain. This includes selecting a dose
to determine the initial efficacy of LUM015 for the molecular imaging of low-grade gliomas,
glioblastomas and cancer masses that have metastasized to the brain.
- Has radiologic imaging with a presumed diagnosis of low grade gliomas, glioblastoma/
grade III glioma or cancer metastases to the brain and must be scheduled for surgical
- Male or female subjects 18 years of age or older
- Subjects must have normal liver, kidney, and bone marrow function as defined below:
- Leukocytes > 3,000/mcL
- Platelets > 100,000/mcL
- total bilirubin within normal institutional limits
- AST (SGOT)/ALT (SGPT) < 2.5 X institutional upper limit of normal
- Creatinine ≤ 1.5 mg/dL or creatinine clearance > 60 mL/min/1.73 m2 for subjects
with creatinine levels above institutional normal.
- Women of child-bearing potential must agree to use adequate contraception (hormonal or
barrier method of birth control, abstinence) starting the day entering the study, and
for 60 days after injection of the imaging agent
- Subjects with ECOG performance status of 0 or 1
- Subjects previously treated with systemic therapies to treat the cancer to be removed
during this clinical investigation, such as neo-adjuvant chemotherapy or hormonal
- Subjects with a known current condition of substance addiction.
- Subjects who have taken an investigational drug within 30 days of enrollment or those
who have not recovered from adverse events due to pharmaceutical or diagnostic agents.
- Subjects with uncontrolled hypertension defined as persistent systolic blood pressure
> 180 mm Hg, or diastolic blood pressure > 110 mm Hg; those subjects with known HTN
should be stable within these ranges while under pharmaceutical therapy.
- History of allergic reaction attributed to drugs containing polyethylene glycol (PEG).
- History of allergic reaction to any oral or intravenous contrast agents.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, COPD or asthma requiring hospitalization within the past 12 months, or
psychiatric illness/social situations that would limit compliance with study
- Subjects who are pregnant or nursing.
- Subjects who are sexually active and not willing/able to use medically acceptable
forms of contraception upon entering the study.
- HIV-positive individuals on combination antiretroviral therapy are ineligible because
of the potential for pharmacokinetic interactions with LUM015.