Coronary Artery Disease
Conditions
Keywords
myocardial perfusion imaging, pharmacological stress, biodistribution, positron emission tomography, myocardial blood flow
Brief summary
This study is a single center, early phase 1 clinical imaging study designed to assess the dosimetry of 68Ga-Galmydar for PET/CT imaging.
Detailed description
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.
Interventions
DRUGGa-68 Galmydar
Single intravenous injection of the PET radiotracer 68Ga-Galmydar.
Sponsors
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
• Healthy men and women, 18-99 years of age and any race
Exclusion criteria
* Inability to receive and sign informed consent; * Positive urine screen for drugs of abuse at screening or before dosing or over-the- counter drug use or herbal preparations within the 2-week period prior to enrollment; * Participation in another research study with a study drug, including a diagnostic or therapeutic radiopharmaceutical, to be administered during this study or which was or will be administered within 10 hall-lives of the radiopharmaceutical. * Severe claustrophobia; * Pregnant or breastfeeding. * Body mass index \< 18 kg/m2 or \> 40 kg/m2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Organ Dosimetry | 6 hours from 68Ga-Galmydar injection | 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. |
| Biodistribution | 6 hours from 68Ga-Galmydar injection | 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. |
| Total Effective Dose of the Radiotracer | 6 hours from 68Ga-Galmydar injection | Total Effective Dose of the radiotracer is calculated using ICRP-60 organ weights and is reported in rem/mCi. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinically Significant Elevation in Oral Temperature | 6 hours from 68Ga-Galmydar injection | Oral temperature of \>100 degrees F. |
| Clinically Significant Change in EKG Showing New AV Block | 6 hours from 68Ga-Galmydar injection | A change in EKG showing new AV Block (Type 1 or Type 2), Mobitz 2:1, or QTc ≥ 500ms). |
| Clinically Significant Change in EKG Showing New Bradycardia | 6 hours from 68Ga-Galmydar injection | New heart rate \< 40 BPM. |
| Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2 | 6 hours from 68Ga-Galmydar injection | 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. |
| Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin | 6 hours from 68Ga-Galmydar injection | 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. |
| Clinically Significant Change in Serum Chemistries: Total Protein, Albumin. | 6 hours from 68Ga-Galmydar injection | Serum chemistries (total protein, albumin), measured in g/dL. Values outside of laboratory range in comparison to baseline or \>20% difference from baseline values. |
| Clinically Significant Change in Blood Pressure. | 6 hours from 68Ga-Galmydar injection | 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. |
| Clinically Significant Change in White Blood Cell Count (WBC) | 6 hours from 68Ga-Galmydar injection | White blood cell count measured in WBC/mm3 blood. Values outside of laboratory range in comparison to baseline or \>20% difference from baseline values. |
| Clinically Significant Change in Hemoglobin (Hgb) | 6 hours from 68Ga-Galmydar injection | Hgb measured in g/dL. Values outside of laboratory range in comparison to baseline or \>20% difference from baseline values. |
| Clinically Significant Change in Hematocrit (Hct) | 6 hours from 68Ga-Galmydar injection | Hct measured in %. Values outside of laboratory range in comparison to baseline or \>20% difference from baseline values. |
| Clinically Significant Change in Platelets | 6 hours from 68Ga-Galmydar injection | Platelets measured in platelets/mm3 blood. Values outside of laboratory range in comparison to baseline or \>20% difference from baseline values. |
| Clinically Significant Change in Red Blood Cell Count (RBC) | 6 hours from 68Ga-Galmydar injection | RBC measured in million/mm3. Values outside of laboratory range in comparison to baseline or \>20% difference from baseline values. |
| Clinically Significant Change in Mean Corpuscular Volume (MCV) | 6 hours from 68Ga-Galmydar injection | MCV measured in µm3. Values outside of laboratory range in comparison to baseline or \>20% difference from baseline values. |
| Clinically Significant Change in Serum Chemistries: Alkaline Phosphatase, ALT, AST | 6 hours from 68Ga-Galmydar injection | Serum chemistries (alkaline phosphatase), measured in U/L. Values outside of laboratory range in comparison to baseline or \>20% difference from baseline values. |
| Clinically Significant Change in Heart Rate. | 6 hours from 68Ga-Galmydar injection | A heart rate of \< 50 BPM or \> 100 or a 20 BPM change from baseline. |
| Clinically Significant Change in Respiratory Rate. | 6 hours from 68Ga-Galmydar injection | A respiratory rate of \< 12 or \> 20 breaths/min. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dosimetry Group Normal Volunteers will receive a single intravenous injection of 8 mCi ± 20% (6.4-9.6 mCi) of the PET radiotracer 68Ga-Galmydar. They will undergo whole-body PET/CT imaging at three-time points, immediately post \[68Ga\]Galmydar injection, and at 2 hours and 4 hours after injection. Serum chemistries, complete blood count, EKG, vital signs, and physical examination will performed before injection and at the completion of the examinations.
Ga-68 Galmydar: Single intravenous injection of the PET radiotracer 68Ga-Galmydar. | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Dosimetry Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 29.1 years STANDARD_DEVIATION 4.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 4 Participants |
| Weight | 79.4 kg STANDARD_DEVIATION 18.3 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dosimetry Group | Biodistribution | 1.923 rad/mCi | Standard Deviation 1.134 |
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dosimetry Group | Organ Dosimetry | Esophagus | 0.034 rad/mCi | Standard Deviation 0.008 |
| Dosimetry Group | Organ Dosimetry | Eyes | 0.018 rad/mCi | Standard Deviation 0.007 |
| Dosimetry Group | Organ Dosimetry | Gallbladder Wall | 1.923 rad/mCi | Standard Deviation 1.134 |
| Dosimetry Group | Organ Dosimetry | Left Colon | 0.107 rad/mCi | Standard Deviation 0.037 |
| Dosimetry Group | Organ Dosimetry | Small Intestine | 0.405 rad/mCi | Standard Deviation 0.181 |
| Dosimetry Group | Organ Dosimetry | Stomach Wall | 0.037 rad/mCi | Standard Deviation 0.008 |
| Dosimetry Group | Organ Dosimetry | Right Colon | 0.327 rad/mCi | Standard Deviation 0.157 |
| Dosimetry Group | Organ Dosimetry | Rectum | 0.037 rad/mCi | Standard Deviation 0.007 |
| Dosimetry Group | Organ Dosimetry | Heart Wall | 0.110 rad/mCi | Standard Deviation 0.026 |
| Dosimetry Group | Organ Dosimetry | Kidneys | 0.483 rad/mCi | Standard Deviation 0.197 |
| Dosimetry Group | Organ Dosimetry | Liver | 0.364 rad/mCi | Standard Deviation 0.039 |
| Dosimetry Group | Organ Dosimetry | Lungs | 0.032 rad/mCi | Standard Deviation 0.008 |
| Dosimetry Group | Organ Dosimetry | Brain | 0.019 rad/mCi | Standard Deviation 0.007 |
| Dosimetry Group | Organ Dosimetry | Breasts | 0.012 rad/mCi | Standard Deviation 0.014 |
| Dosimetry Group | Organ Dosimetry | Adrenals | 0.109 rad/mCi | Standard Deviation 0.015 |
| Dosimetry Group | Organ Dosimetry | Ovaries | 0.042 rad/mCi | Standard Deviation 0.009 |
| Dosimetry Group | Organ Dosimetry | Pancreas | 0.046 rad/mCi | Standard Deviation 0.024 |
| Dosimetry Group | Organ Dosimetry | Salivary Glands | 0.378 rad/mCi | Standard Deviation 0.554 |
| Dosimetry Group | Organ Dosimetry | Red Marrow | 0.064 rad/mCi | Standard Deviation 0.021 |
| Dosimetry Group | Organ Dosimetry | Osteogenic Cells | 0.041 rad/mCi | Standard Deviation 0.01 |
| Dosimetry Group | Organ Dosimetry | Spleen | 0.246 rad/mCi | Standard Deviation 0.055 |
| Dosimetry Group | Organ Dosimetry | Thymus | 0.022 rad/mCi | Standard Deviation 0.01 |
| Dosimetry Group | Organ Dosimetry | Thyroid | 0.098 rad/mCi | Standard Deviation 0.091 |
| Dosimetry Group | Organ Dosimetry | Urinary Bladder Wall | 0.137 rad/mCi | Standard Deviation 0.018 |
| Dosimetry Group | Organ Dosimetry | Uterus | 0.066 rad/mCi | Standard Deviation 0.031 |
| Dosimetry Group | Organ Dosimetry | Total Body | 0.045 rad/mCi | Standard Deviation 0.007 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dosimetry Group | Total Effective Dose of the Radiotracer | 0.103 rem/mCi | Standard Deviation 0.012 |
Secondary
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
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dosimetry Group | Clinically Significant Change in Blood Pressure. | Baseline Systolic Blood Pressure | Normal | 8 Participants |
| Dosimetry Group | Clinically Significant Change in Blood Pressure. | Baseline Systolic Blood Pressure | Abnormal | 0 Participants |
| Dosimetry Group | Clinically Significant Change in Blood Pressure. | Post-Injection Systolic Blood Pressure | Normal | 8 Participants |
| Dosimetry Group | Clinically Significant Change in Blood Pressure. | Post-Injection Systolic Blood Pressure | Abnormal | 0 Participants |
| Dosimetry Group | Clinically Significant Change in Blood Pressure. | Baseline Diastolic Blood Pressure | Normal | 8 Participants |
| Dosimetry Group | Clinically Significant Change in Blood Pressure. | Baseline Diastolic Blood Pressure | Abnormal | 0 Participants |
| Dosimetry Group | Clinically Significant Change in Blood Pressure. | Post-Injection Diastolic Blood Pressure | Normal | 8 Participants |
| Dosimetry Group | Clinically Significant Change in Blood Pressure. | Post-Injection Diastolic Blood Pressure | Abnormal | 0 Participants |
Secondary
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
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dosimetry Group | Clinically Significant Change in EKG Showing New AV Block | Baseline EKG | Normal | 8 Participants |
| Dosimetry Group | Clinically Significant Change in EKG Showing New AV Block | Baseline EKG | Abnormal | 0 Participants |
| Dosimetry Group | Clinically Significant Change in EKG Showing New AV Block | Post-Injection EKG | Normal | 8 Participants |
| Dosimetry Group | Clinically Significant Change in EKG Showing New AV Block | Post-Injection EKG | Abnormal | 0 Participants |
Secondary
Clinically Significant Change in EKG Showing New Bradycardia
New heart rate \< 40 BPM.
Time frame: 6 hours from 68Ga-Galmydar injection
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dosimetry Group | Clinically Significant Change in EKG Showing New Bradycardia | Baseline EKG | Normal | 8 Participants |
| Dosimetry Group | Clinically Significant Change in EKG Showing New Bradycardia | Baseline EKG | Abnormal | 0 Participants |
| Dosimetry Group | Clinically Significant Change in EKG Showing New Bradycardia | Post-Injection EKG | Normal | 8 Participants |
| Dosimetry Group | Clinically Significant Change in EKG Showing New Bradycardia | Post-Injection EKG | Abnormal | 0 Participants |
Secondary
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
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dosimetry Group | Clinically Significant Change in Heart Rate. | Baseline Heart Rate | Normal | 8 Participants |
| Dosimetry Group | Clinically Significant Change in Heart Rate. | Baseline Heart Rate | Abnormal | 0 Participants |
| Dosimetry Group | Clinically Significant Change in Heart Rate. | Post-Injection Heart Rate | Normal | 8 Participants |
| Dosimetry Group | Clinically Significant Change in Heart Rate. | Post-Injection Heart Rate | Abnormal | 0 Participants |
Secondary
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
Population: All patients were scheduled to undergo complete blood count (CBC). Three patients did not undergo post-injection CBC due to various issues (IV or blood hemolysis).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dosimetry Group | Clinically Significant Change in Hematocrit (Hct) | Baseline Hematocrit | Normal | 6 Participants |
| Dosimetry Group | Clinically Significant Change in Hematocrit (Hct) | Baseline Hematocrit | Abnormal | 2 Participants |
| Dosimetry Group | Clinically Significant Change in Hematocrit (Hct) | Post-Injection Hematocrit | Normal | 2 Participants |
| Dosimetry Group | Clinically Significant Change in Hematocrit (Hct) | Post-Injection Hematocrit | Abnormal | 3 Participants |
p-value: 1McNemar
Secondary
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
Population: All patients were scheduled to undergo complete blood count (CBC). Three patients did not undergo post-injection CBC due to various issues (IV or blood hemolysis).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dosimetry Group | Clinically Significant Change in Hemoglobin (Hgb) | Baseline Hemoglobin | Normal | 7 Participants |
| Dosimetry Group | Clinically Significant Change in Hemoglobin (Hgb) | Baseline Hemoglobin | Abnormal | 1 Participants |
| Dosimetry Group | Clinically Significant Change in Hemoglobin (Hgb) | Post-Injection Hemoglobin | Normal | 4 Participants |
| Dosimetry Group | Clinically Significant Change in Hemoglobin (Hgb) | Post-Injection Hemoglobin | Abnormal | 1 Participants |
p-value: 0.375McNemar
Secondary
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
Population: All patients were scheduled to undergo complete blood count (CBC). Three patients did not undergo post-injection CBC due to various issues (IV or blood hemolysis).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dosimetry Group | Clinically Significant Change in Mean Corpuscular Volume (MCV) | Baseline MCV | Normal | 8 Participants |
| Dosimetry Group | Clinically Significant Change in Mean Corpuscular Volume (MCV) | Baseline MCV | Abnormal | 0 Participants |
| Dosimetry Group | Clinically Significant Change in Mean Corpuscular Volume (MCV) | Post-Injection MCV | Normal | 5 Participants |
| Dosimetry Group | Clinically Significant Change in Mean Corpuscular Volume (MCV) | Post-Injection MCV | Abnormal | 0 Participants |
Secondary
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
Population: All patients were scheduled to undergo complete blood count (CBC). Three patients did not undergo post-injection CBC due to various issues (IV or blood hemolysis).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dosimetry Group | Clinically Significant Change in Platelets | Post-Injection Platelets | Normal | 5 Participants |
| Dosimetry Group | Clinically Significant Change in Platelets | Baseline Platelets | Normal | 8 Participants |
| Dosimetry Group | Clinically Significant Change in Platelets | Baseline Platelets | Abnormal | 0 Participants |
| Dosimetry Group | Clinically Significant Change in Platelets | Post-Injection Platelets | Abnormal | 0 Participants |
Secondary
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
Population: All patients were scheduled to undergo complete blood count (CBC). Three patients did not undergo post-injection CBC due to various issues (IV or blood hemolysis).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dosimetry Group | Clinically Significant Change in Red Blood Cell Count (RBC) | Baseline RBC | Normal | 7 Participants |
| Dosimetry Group | Clinically Significant Change in Red Blood Cell Count (RBC) | Baseline RBC | Abnormal | 1 Participants |
| Dosimetry Group | Clinically Significant Change in Red Blood Cell Count (RBC) | Post-Injection RBC | Normal | 4 Participants |
| Dosimetry Group | Clinically Significant Change in Red Blood Cell Count (RBC) | Post-Injection RBC | Abnormal | 1 Participants |
p-value: 0.375McNemar
Secondary
Clinically Significant Change in Respiratory Rate.
A respiratory rate of \< 12 or \> 20 breaths/min.
Time frame: 6 hours from 68Ga-Galmydar injection
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dosimetry Group | Clinically Significant Change in Respiratory Rate. | Baseline Respiratory Rate | Normal | 8 Participants |
| Dosimetry Group | Clinically Significant Change in Respiratory Rate. | Baseline Respiratory Rate | Abnormal | 0 Participants |
| Dosimetry Group | Clinically Significant Change in Respiratory Rate. | Post-Injection Respiratory Rate | Normal | 7 Participants |
| Dosimetry Group | Clinically Significant Change in Respiratory Rate. | Post-Injection Respiratory Rate | Abnormal | 1 Participants |
p-value: 0.016McNemar
Secondary
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
Population: All patients were scheduled to undergo serum chemistries. Three patients did not undergo post-injection serum chemistries due to various issues (IV, blood hemolysis, or wrong labs).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Alkaline Phosphatase, ALT, AST | Baseline Alkaline Phosphatase | Normal | 8 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Alkaline Phosphatase, ALT, AST | Baseline Alkaline Phosphatase | Abnormal | 0 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Alkaline Phosphatase, ALT, AST | Post-Injection Alkaline Phosphatase | Normal | 5 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Alkaline Phosphatase, ALT, AST | Post-Injection Alkaline Phosphatase | Abnormal | 0 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Alkaline Phosphatase, ALT, AST | Baseline ALT | Normal | 7 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Alkaline Phosphatase, ALT, AST | Baseline ALT | Abnormal | 1 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Alkaline Phosphatase, ALT, AST | Post-Injection ALT | Normal | 5 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Alkaline Phosphatase, ALT, AST | Post-Injection ALT | Abnormal | 0 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Alkaline Phosphatase, ALT, AST | Baseline AST | Normal | 8 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Alkaline Phosphatase, ALT, AST | Baseline AST | Abnormal | 0 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Alkaline Phosphatase, ALT, AST | Post-Injection AST | Normal | 5 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Alkaline Phosphatase, ALT, AST | Post-Injection AST | Abnormal | 0 Participants |
p-value: 0.219McNemar
Secondary
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
Population: All patients were scheduled to undergo serum chemistries. Three patients did not undergo post-injection serum chemistries due to various issues (IV, blood hemolysis, or wrong labs).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin | Baseline Glucose | Normal | 7 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin | Baseline Glucose | Abnormal | 1 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin | Post-Injection Glucose | Normal | 4 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin | Post-Injection Glucose | Abnormal | 1 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin | Baseline Calcium | Normal | 7 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin | Baseline Calcium | Abnormal | 1 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin | Post-Injection Calcium | Normal | 4 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin | Post-Injection Calcium | Abnormal | 1 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin | Baseline Creatinine | Normal | 6 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin | Baseline Creatinine | Abnormal | 2 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin | Post-Injection Creatinine | Normal | 5 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin | Post-Injection Creatinine | Abnormal | 0 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin | Baseline BUN | Normal | 8 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin | Baseline BUN | Abnormal | 0 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin | Post-Injection BUN | Normal | 4 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin | Post-Injection BUN | Abnormal | 1 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin | Baseline Total Bilirubin | Normal | 7 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin | Baseline Total Bilirubin | Abnormal | 1 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin | Post-Injection Total Bilirubin | Normal | 5 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin | Post-Injection Total Bilirubin | Abnormal | 0 Participants |
p-value: 0.375McNemar
p-value: 0.375McNemar
p-value: 0.453McNemar
p-value: 0.125McNemar
p-value: 0.219McNemar
Secondary
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
Population: All patients were scheduled to undergo serum chemistries. Three patients did not undergo post-injection serum chemistries due to various issues (IV, blood hemolysis, or wrong labs).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2 | Baseline Sodium | Normal | 8 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2 | Baseline Sodium | Abnormal | 0 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2 | Post-Injection Sodium | Normal | 5 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2 | Post-Injection Sodium | Abnormal | 0 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2 | Baseline Potassium | Normal | 8 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2 | Baseline Potassium | Abnormal | 0 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2 | Post-Injection Potassium | Normal | 5 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2 | Post-Injection Potassium | Abnormal | 0 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2 | Baseline Chloride | Normal | 8 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2 | Baseline Chloride | Abnormal | 0 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2 | Post-Injection Chloride | Normal | 5 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2 | Post-Injection Chloride | Abnormal | 0 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2 | Baseline CO2 | Normal | 7 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2 | Baseline CO2 | Abnormal | 1 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2 | Post-Injection CO2 | Normal | 5 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2 | Post-Injection CO2 | Abnormal | 0 Participants |
p-value: 0.219McNemar
Secondary
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
Population: All patients were scheduled to undergo serum chemistries. Three patients did not undergo post-injection serum chemistries due to various issues (IV, blood hemolysis, or wrong labs).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Total Protein, Albumin. | Baseline Total Protein | Normal | 8 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Total Protein, Albumin. | Baseline Total Protein | Abnormal | 0 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Total Protein, Albumin. | Post-Injection Total Protein | Normal | 5 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Total Protein, Albumin. | Post-Injection Total Protein | Abnormal | 0 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Total Protein, Albumin. | Baseline Albumin | Normal | 7 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Total Protein, Albumin. | Baseline Albumin | Abnormal | 1 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Total Protein, Albumin. | Post-Injection Albumin | Normal | 5 Participants |
| Dosimetry Group | Clinically Significant Change in Serum Chemistries: Total Protein, Albumin. | Post-Injection Albumin | Abnormal | 0 Participants |
p-value: 0.219McNemar
Secondary
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
Population: All patients were scheduled to undergo complete blood count (CBC). Three patients did not undergo post-injection CBC due to various issues (IV or blood hemolysis).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dosimetry Group | Clinically Significant Change in White Blood Cell Count (WBC) | Baseline WBC | Normal | 6 Participants |
| Dosimetry Group | Clinically Significant Change in White Blood Cell Count (WBC) | Baseline WBC | Abnormal | 2 Participants |
| Dosimetry Group | Clinically Significant Change in White Blood Cell Count (WBC) | Post-Injection WBC | Normal | 4 Participants |
| Dosimetry Group | Clinically Significant Change in White Blood Cell Count (WBC) | Post-Injection WBC | Abnormal | 1 Participants |
p-value: 0.687McNemar
Secondary
Clinically Significant Elevation in Oral Temperature
Oral temperature of \>100 degrees F.
Time frame: 6 hours from 68Ga-Galmydar injection
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dosimetry Group | Clinically Significant Elevation in Oral Temperature | Baseline Temperature | Normal | 8 Participants |
| Dosimetry Group | Clinically Significant Elevation in Oral Temperature | Baseline Temperature | Abnormal | 0 Participants |
| Dosimetry Group | Clinically Significant Elevation in Oral Temperature | Post-Injection Temperature | Normal | 8 Participants |
| Dosimetry Group | Clinically Significant Elevation in Oral Temperature | Post-Injection Temperature | Abnormal | 0 Participants |