This study is a single center, early phase 1 clinical imaging study designed to assess the dosimetry of 68Ga-Galmydar for PET/CT imaging.
The objective is to evaluate dosimetry, biodistribution, safety, and imaging characteristics following a single 68Ga-Galmydar injection in normal healthy volunteers. Healthy adult normal volunteers (n=8, 4 males; 4 females) will undergo whole-body imaging (dosimetry group). Healthy adult normal volunteers (n=8, 4 males; 4 females) will receive a single intravenous Ga-68 Galmydar administration of 8 mCi ± 20% (6.4-9.6 mCi) with a mass of ≤ 10 µg followed by whole-body PET/CT imaging.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
8
Single intravenous injection of the PET radiotracer 68Ga-Galmydar.
Washington University School of Medicine
St Louis, Missouri, United States
Organ Dosimetry
On whole body PET/CT, regions of interest are drawn on the liver, spleen, kidney, lumbar vertebrae and left ventricle of the heart. Average organ dose is measured and compared. Organ radiation dose is measured and reported in rad/mCi.
Time frame: 6 hours from 68Ga-Galmydar injection
Biodistribution
The organ with the highest radiation dose in rad/mCi is determined to be the dose-critical organ. The organ showing the largest dose is the gallbladder wall.
Time frame: 6 hours from 68Ga-Galmydar injection
Total Effective Dose of the Radiotracer
Total Effective Dose of the radiotracer is calculated using ICRP-60 organ weights and is reported in rem/mCi.
Time frame: 6 hours from 68Ga-Galmydar injection
Clinically Significant Change in Blood Pressure.
The following variables are considered clinically significant if changes occur from baseline. A systolic BP of \< 90 or \> 160 mmHg or a diastolic BP of \< 50 or \> 100 mmHg or a 20 mmHg change from baseline in the SBP or DBP.
Time frame: 6 hours from 68Ga-Galmydar injection
Clinically Significant Change in Heart Rate.
A heart rate of \< 50 BPM or \> 100 or a 20 BPM change from baseline.
Time frame: 6 hours from 68Ga-Galmydar injection
Clinically Significant Change in Respiratory Rate.
A respiratory rate of \< 12 or \> 20 breaths/min.
Time frame: 6 hours from 68Ga-Galmydar injection
Clinically Significant Elevation in Oral Temperature
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Oral temperature of \>100 degrees F.
Time frame: 6 hours from 68Ga-Galmydar injection
Clinically Significant Change in EKG Showing New AV Block
A change in EKG showing new AV Block (Type 1 or Type 2), Mobitz 2:1, or QTc ≥ 500ms).
Time frame: 6 hours from 68Ga-Galmydar injection
Clinically Significant Change in EKG Showing New Bradycardia
New heart rate \< 40 BPM.
Time frame: 6 hours from 68Ga-Galmydar injection
Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2
Serum chemistries (sodium, potassium, chloride, CO2) measured in mmol/L. Values outside of laboratory range in comparison to baseline or \>20% difference from baseline values.
Time frame: 6 hours from 68Ga-Galmydar injection
Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin
Serum chemistries (glucose, calcium creatinine, BUN, total bilirubin), measured in mg/dL. Values outside of laboratory range in comparison to baseline or \>20% difference from baseline values.
Time frame: 6 hours from 68Ga-Galmydar injection
Clinically Significant Change in Serum Chemistries: Total Protein, Albumin.
Serum chemistries (total protein, albumin), measured in g/dL. Values outside of laboratory range in comparison to baseline or \>20% difference from baseline values.
Time frame: 6 hours from 68Ga-Galmydar injection
Clinically Significant Change in Serum Chemistries: Alkaline Phosphatase, ALT, AST
Serum chemistries (alkaline phosphatase), measured in U/L. Values outside of laboratory range in comparison to baseline or \>20% difference from baseline values.
Time frame: 6 hours from 68Ga-Galmydar injection
Clinically Significant Change in White Blood Cell Count (WBC)
White blood cell count measured in WBC/mm3 blood. Values outside of laboratory range in comparison to baseline or \>20% difference from baseline values.
Time frame: 6 hours from 68Ga-Galmydar injection
Clinically Significant Change in Hemoglobin (Hgb)
Hgb measured in g/dL. Values outside of laboratory range in comparison to baseline or \>20% difference from baseline values.
Time frame: 6 hours from 68Ga-Galmydar injection
Clinically Significant Change in Hematocrit (Hct)
Hct measured in %. Values outside of laboratory range in comparison to baseline or \>20% difference from baseline values.
Time frame: 6 hours from 68Ga-Galmydar injection
Clinically Significant Change in Platelets
Platelets measured in platelets/mm3 blood. Values outside of laboratory range in comparison to baseline or \>20% difference from baseline values.
Time frame: 6 hours from 68Ga-Galmydar injection
Clinically Significant Change in Red Blood Cell Count (RBC)
RBC measured in million/mm3. Values outside of laboratory range in comparison to baseline or \>20% difference from baseline values.
Time frame: 6 hours from 68Ga-Galmydar injection
Clinically Significant Change in Mean Corpuscular Volume (MCV)
MCV measured in µm3. Values outside of laboratory range in comparison to baseline or \>20% difference from baseline values.
Time frame: 6 hours from 68Ga-Galmydar injection