Imaging Trial With I-124-CLR1404 in Patients With Newly Diagnosed or Recurrent Glioblastoma

Study Overview
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Brief Summary
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The primary objective of this trial is to determine the optimal dose and imaging time point(s) of I-124-CLR1404 in subjects with newly diagnosed and recurrent glioma to be used in future trials.

Official Title
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Phase 2, Open-Label, Imaging Trial of I-124-CLR1404 in Patients With Newly Diagnosed or Recurrent Glioblastoma

Conditions
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Glioblastoma

Intervention / Treatment
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* Drug: I-124-CLR1404


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: newly diagnosed glioblastoma or recurrent/suspected recurrent glioblastoma scheduled to undergo a clinically-indicated surgery or biopsy (specific cohorts) ECOG performance status of 0 to 2 (Appendix C) 18 years of age or older has the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits has the ability to read, understand and provide written informed consent for the initiation of any study related procedures (or legal representative) if female of childbearing potential must have a negative pregnancy test within 24 hours of enrollment Women of childbearing potential and men who are able to father a child, must agree to use an effective method of contraception (e.g., oral contraceptives, double-barrier methods such as a condom and a diaphragm, intrauterine device, Norplant, Depo-Provera) during the study and for 45 days following the last dose of the study drug. Exclusion Criteria: ongoing grade 2 or greater toxicities due to previous therapies. However, tolerable grade 2 adverse (e.g. neuropathy) events may be allowed at the discretion of the investigator. has following laboratory abnormalities Platelets < 100,000/μL WBC < 3000/μL Hematocrit < 22% Serum creatinine > 2.5 mg/dL ALT > 1.5 x ULN Bilirubin > 1.5 x ULN ongoing chronic immunosuppressive therapy history of hypersensitivity to iodine any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise subject safety or interfere with the evaluation of the safety of the test drug women of childbearing potential, or men who are able to father a child, unwilling to use a medically acceptable method of contraception during the trial pregnancy or breast-feeding inability to comply with the protocol use of any investigational drug within 4 weeks of dosing (unless a longer time period is required by local regulations or the investigational agent)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single<br>I-124-CLR1404, open-label | Drug: I-124-CLR1404<br>* single-dose, intravenous<br>* Other names: I-124-NM404;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optimal Imaging Parameters - Dose | Up to two dose levels (5 mCi and 7.5 mCi) will be evaluated in conjunction with multiple imaging time points to determine the optimal parameters for PET/CT brain imaging. Dosing will begin at 5 mCi and if the images are deemed inadequate, as assessed by count statistics and image quality, the 7.5 mCi dose level will be evaluated. | 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optimal Imaging Parameters - Imaging Time Point | Multiple imaging time points (Day 2, Day 3, and Day 4-8) will be evaluated to determine the optimal parameters for PET/CT brain imaging. | 8 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glioma, Glioblastoma Multiforme, PET, Imaging, Radiopharmaceutical, Diagnostic