Feasibility of the LUM Imaging System for Detection of Cancer to the Brain (NCT03717142) | Clinical Trial Compass
TerminatedNot Applicable
Feasibility of the LUM Imaging System for Detection of Cancer to the Brain
Stopped: Initial data indicated a change in study design required prior to collecting additional data.
United States4 participantsStarted 2019-05-03
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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 resection
* 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
Exclusion Criteria:
* Subjects previously treated with systemic therapies to treat the cancer to be removed during this clinical investigation, such as neo-adjuvant chemotherapy or hormonal therapy.
* 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 pr…
What they're measuring
1
Correlation of fluorescence levels in normal and tumor tissue by dose of LUM015