Trial Outcomes & Findings for Development and Translation of Generator-Produced PET Tracer for Myocardial Perfusion Imaging-Dosimetry Group (NCT NCT05280782)
NCT ID: NCT05280782
Last Updated: 2023-09-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
8 participants
Primary outcome timeframe
6 hours from 68Ga-Galmydar injection
Results posted on
2023-09-08
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Development and Translation of Generator-Produced PET Tracer for Myocardial Perfusion Imaging-Dosimetry Group
Baseline characteristics by cohort
| Measure |
Dosimetry Group
n=8 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
29.1 years
STANDARD_DEVIATION 4.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Weight
|
79.4 kg
STANDARD_DEVIATION 18.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 hours from 68Ga-Galmydar injectionOn 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.
Outcome measures
| Measure |
Dosimetry Group
n=8 Participants
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.
|
|---|---|
|
Organ Dosimetry
Adrenals
|
0.109 rad/mCi
Standard Deviation 0.015
|
|
Organ Dosimetry
Brain
|
0.019 rad/mCi
Standard Deviation 0.007
|
|
Organ Dosimetry
Breasts
|
0.012 rad/mCi
Standard Deviation 0.014
|
|
Organ Dosimetry
Esophagus
|
0.034 rad/mCi
Standard Deviation 0.008
|
|
Organ Dosimetry
Eyes
|
0.018 rad/mCi
Standard Deviation 0.007
|
|
Organ Dosimetry
Gallbladder Wall
|
1.923 rad/mCi
Standard Deviation 1.134
|
|
Organ Dosimetry
Left Colon
|
0.107 rad/mCi
Standard Deviation 0.037
|
|
Organ Dosimetry
Small Intestine
|
0.405 rad/mCi
Standard Deviation 0.181
|
|
Organ Dosimetry
Stomach Wall
|
0.037 rad/mCi
Standard Deviation 0.008
|
|
Organ Dosimetry
Right Colon
|
0.327 rad/mCi
Standard Deviation 0.157
|
|
Organ Dosimetry
Rectum
|
0.037 rad/mCi
Standard Deviation 0.007
|
|
Organ Dosimetry
Heart Wall
|
0.110 rad/mCi
Standard Deviation 0.026
|
|
Organ Dosimetry
Kidneys
|
0.483 rad/mCi
Standard Deviation 0.197
|
|
Organ Dosimetry
Liver
|
0.364 rad/mCi
Standard Deviation 0.039
|
|
Organ Dosimetry
Lungs
|
0.032 rad/mCi
Standard Deviation 0.008
|
|
Organ Dosimetry
Ovaries
|
0.042 rad/mCi
Standard Deviation 0.009
|
|
Organ Dosimetry
Pancreas
|
0.046 rad/mCi
Standard Deviation 0.024
|
|
Organ Dosimetry
Salivary Glands
|
0.378 rad/mCi
Standard Deviation 0.554
|
|
Organ Dosimetry
Red Marrow
|
0.064 rad/mCi
Standard Deviation 0.021
|
|
Organ Dosimetry
Osteogenic Cells
|
0.041 rad/mCi
Standard Deviation 0.010
|
|
Organ Dosimetry
Spleen
|
0.246 rad/mCi
Standard Deviation 0.055
|
|
Organ Dosimetry
Thymus
|
0.022 rad/mCi
Standard Deviation 0.010
|
|
Organ Dosimetry
Thyroid
|
0.098 rad/mCi
Standard Deviation 0.091
|
|
Organ Dosimetry
Urinary Bladder Wall
|
0.137 rad/mCi
Standard Deviation 0.018
|
|
Organ Dosimetry
Uterus
|
0.066 rad/mCi
Standard Deviation 0.031
|
|
Organ Dosimetry
Total Body
|
0.045 rad/mCi
Standard Deviation 0.007
|
PRIMARY outcome
Timeframe: 6 hours from 68Ga-Galmydar injectionThe 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.
Outcome measures
| Measure |
Dosimetry Group
n=8 Participants
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.
|
|---|---|
|
Biodistribution
|
1.923 rad/mCi
Standard Deviation 1.134
|
PRIMARY outcome
Timeframe: 6 hours from 68Ga-Galmydar injectionTotal Effective Dose of the radiotracer is calculated using ICRP-60 organ weights and is reported in rem/mCi.
Outcome measures
| Measure |
Dosimetry Group
n=8 Participants
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.
|
|---|---|
|
Total Effective Dose of the Radiotracer
|
0.103 rem/mCi
Standard Deviation 0.012
|
SECONDARY outcome
Timeframe: 6 hours from 68Ga-Galmydar injectionThe 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.
Outcome measures
| Measure |
Dosimetry Group
n=8 Participants
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.
|
|---|---|
|
Clinically Significant Change in Blood Pressure.
Baseline Systolic Blood Pressure · Normal
|
8 Participants
|
|
Clinically Significant Change in Blood Pressure.
Baseline Systolic Blood Pressure · Abnormal
|
0 Participants
|
|
Clinically Significant Change in Blood Pressure.
Post-Injection Systolic Blood Pressure · Normal
|
8 Participants
|
|
Clinically Significant Change in Blood Pressure.
Post-Injection Systolic Blood Pressure · Abnormal
|
0 Participants
|
|
Clinically Significant Change in Blood Pressure.
Baseline Diastolic Blood Pressure · Normal
|
8 Participants
|
|
Clinically Significant Change in Blood Pressure.
Baseline Diastolic Blood Pressure · Abnormal
|
0 Participants
|
|
Clinically Significant Change in Blood Pressure.
Post-Injection Diastolic Blood Pressure · Normal
|
8 Participants
|
|
Clinically Significant Change in Blood Pressure.
Post-Injection Diastolic Blood Pressure · Abnormal
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 hours from 68Ga-Galmydar injectionA heart rate of \< 50 BPM or \> 100 or a 20 BPM change from baseline.
Outcome measures
| Measure |
Dosimetry Group
n=8 Participants
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.
|
|---|---|
|
Clinically Significant Change in Heart Rate.
Baseline Heart Rate · Normal
|
8 Participants
|
|
Clinically Significant Change in Heart Rate.
Baseline Heart Rate · Abnormal
|
0 Participants
|
|
Clinically Significant Change in Heart Rate.
Post-Injection Heart Rate · Normal
|
8 Participants
|
|
Clinically Significant Change in Heart Rate.
Post-Injection Heart Rate · Abnormal
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 hours from 68Ga-Galmydar injectionA respiratory rate of \< 12 or \> 20 breaths/min.
Outcome measures
| Measure |
Dosimetry Group
n=8 Participants
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.
|
|---|---|
|
Clinically Significant Change in Respiratory Rate.
Baseline Respiratory Rate · Normal
|
8 Participants
|
|
Clinically Significant Change in Respiratory Rate.
Baseline Respiratory Rate · Abnormal
|
0 Participants
|
|
Clinically Significant Change in Respiratory Rate.
Post-Injection Respiratory Rate · Normal
|
7 Participants
|
|
Clinically Significant Change in Respiratory Rate.
Post-Injection Respiratory Rate · Abnormal
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 hours from 68Ga-Galmydar injectionOral temperature of \>100 degrees F.
Outcome measures
| Measure |
Dosimetry Group
n=8 Participants
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.
|
|---|---|
|
Clinically Significant Elevation in Oral Temperature
Baseline Temperature · Normal
|
8 Participants
|
|
Clinically Significant Elevation in Oral Temperature
Baseline Temperature · Abnormal
|
0 Participants
|
|
Clinically Significant Elevation in Oral Temperature
Post-Injection Temperature · Normal
|
8 Participants
|
|
Clinically Significant Elevation in Oral Temperature
Post-Injection Temperature · Abnormal
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 hours from 68Ga-Galmydar injectionA change in EKG showing new AV Block (Type 1 or Type 2), Mobitz 2:1, or QTc ≥ 500ms).
Outcome measures
| Measure |
Dosimetry Group
n=8 Participants
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.
|
|---|---|
|
Clinically Significant Change in EKG Showing New AV Block
Baseline EKG · Normal
|
8 Participants
|
|
Clinically Significant Change in EKG Showing New AV Block
Baseline EKG · Abnormal
|
0 Participants
|
|
Clinically Significant Change in EKG Showing New AV Block
Post-Injection EKG · Normal
|
8 Participants
|
|
Clinically Significant Change in EKG Showing New AV Block
Post-Injection EKG · Abnormal
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 hours from 68Ga-Galmydar injectionNew heart rate \< 40 BPM.
Outcome measures
| Measure |
Dosimetry Group
n=8 Participants
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.
|
|---|---|
|
Clinically Significant Change in EKG Showing New Bradycardia
Baseline EKG · Normal
|
8 Participants
|
|
Clinically Significant Change in EKG Showing New Bradycardia
Baseline EKG · Abnormal
|
0 Participants
|
|
Clinically Significant Change in EKG Showing New Bradycardia
Post-Injection EKG · Normal
|
8 Participants
|
|
Clinically Significant Change in EKG Showing New Bradycardia
Post-Injection EKG · Abnormal
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 hours from 68Ga-Galmydar injectionPopulation: 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).
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.
Outcome measures
| Measure |
Dosimetry Group
n=8 Participants
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.
|
|---|---|
|
Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2
Baseline CO2 · Normal
|
7 Participants
|
|
Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2
Post-Injection CO2 · Normal
|
5 Participants
|
|
Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2
Baseline Sodium · Normal
|
8 Participants
|
|
Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2
Baseline Sodium · Abnormal
|
0 Participants
|
|
Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2
Post-Injection Sodium · Normal
|
5 Participants
|
|
Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2
Post-Injection Sodium · Abnormal
|
0 Participants
|
|
Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2
Baseline Potassium · Normal
|
8 Participants
|
|
Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2
Baseline Potassium · Abnormal
|
0 Participants
|
|
Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2
Post-Injection Potassium · Normal
|
5 Participants
|
|
Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2
Post-Injection Potassium · Abnormal
|
0 Participants
|
|
Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2
Baseline Chloride · Normal
|
8 Participants
|
|
Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2
Baseline Chloride · Abnormal
|
0 Participants
|
|
Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2
Post-Injection Chloride · Normal
|
5 Participants
|
|
Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2
Post-Injection Chloride · Abnormal
|
0 Participants
|
|
Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2
Baseline CO2 · Abnormal
|
1 Participants
|
|
Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2
Post-Injection CO2 · Abnormal
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 hours from 68Ga-Galmydar injectionPopulation: 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).
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.
Outcome measures
| Measure |
Dosimetry Group
n=8 Participants
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.
|
|---|---|
|
Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin
Baseline Glucose · Normal
|
7 Participants
|
|
Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin
Baseline Glucose · Abnormal
|
1 Participants
|
|
Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin
Post-Injection Glucose · Normal
|
4 Participants
|
|
Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin
Post-Injection Glucose · Abnormal
|
1 Participants
|
|
Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin
Baseline Calcium · Normal
|
7 Participants
|
|
Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin
Baseline Calcium · Abnormal
|
1 Participants
|
|
Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin
Post-Injection Calcium · Normal
|
4 Participants
|
|
Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin
Post-Injection Calcium · Abnormal
|
1 Participants
|
|
Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin
Baseline Creatinine · Normal
|
6 Participants
|
|
Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin
Baseline Creatinine · Abnormal
|
2 Participants
|
|
Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin
Post-Injection Creatinine · Normal
|
5 Participants
|
|
Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin
Post-Injection Creatinine · Abnormal
|
0 Participants
|
|
Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin
Baseline BUN · Normal
|
8 Participants
|
|
Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin
Baseline BUN · Abnormal
|
0 Participants
|
|
Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin
Post-Injection BUN · Normal
|
4 Participants
|
|
Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin
Post-Injection BUN · Abnormal
|
1 Participants
|
|
Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin
Baseline Total Bilirubin · Normal
|
7 Participants
|
|
Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin
Baseline Total Bilirubin · Abnormal
|
1 Participants
|
|
Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin
Post-Injection Total Bilirubin · Normal
|
5 Participants
|
|
Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin
Post-Injection Total Bilirubin · Abnormal
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 hours from 68Ga-Galmydar injectionPopulation: 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).
Serum chemistries (total protein, albumin), measured in g/dL. Values outside of laboratory range in comparison to baseline or \>20% difference from baseline values.
Outcome measures
| Measure |
Dosimetry Group
n=8 Participants
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.
|
|---|---|
|
Clinically Significant Change in Serum Chemistries: Total Protein, Albumin.
Baseline Total Protein · Normal
|
8 Participants
|
|
Clinically Significant Change in Serum Chemistries: Total Protein, Albumin.
Baseline Total Protein · Abnormal
|
0 Participants
|
|
Clinically Significant Change in Serum Chemistries: Total Protein, Albumin.
Post-Injection Total Protein · Normal
|
5 Participants
|
|
Clinically Significant Change in Serum Chemistries: Total Protein, Albumin.
Post-Injection Total Protein · Abnormal
|
0 Participants
|
|
Clinically Significant Change in Serum Chemistries: Total Protein, Albumin.
Baseline Albumin · Normal
|
7 Participants
|
|
Clinically Significant Change in Serum Chemistries: Total Protein, Albumin.
Baseline Albumin · Abnormal
|
1 Participants
|
|
Clinically Significant Change in Serum Chemistries: Total Protein, Albumin.
Post-Injection Albumin · Normal
|
5 Participants
|
|
Clinically Significant Change in Serum Chemistries: Total Protein, Albumin.
Post-Injection Albumin · Abnormal
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 hours from 68Ga-Galmydar injectionPopulation: 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).
Serum chemistries (alkaline phosphatase), measured in U/L. Values outside of laboratory range in comparison to baseline or \>20% difference from baseline values.
Outcome measures
| Measure |
Dosimetry Group
n=8 Participants
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.
|
|---|---|
|
Clinically Significant Change in Serum Chemistries: Alkaline Phosphatase, ALT, AST
Post-Injection ALT · Normal
|
5 Participants
|
|
Clinically Significant Change in Serum Chemistries: Alkaline Phosphatase, ALT, AST
Post-Injection ALT · Abnormal
|
0 Participants
|
|
Clinically Significant Change in Serum Chemistries: Alkaline Phosphatase, ALT, AST
Baseline AST · Normal
|
8 Participants
|
|
Clinically Significant Change in Serum Chemistries: Alkaline Phosphatase, ALT, AST
Baseline AST · Abnormal
|
0 Participants
|
|
Clinically Significant Change in Serum Chemistries: Alkaline Phosphatase, ALT, AST
Post-Injection AST · Normal
|
5 Participants
|
|
Clinically Significant Change in Serum Chemistries: Alkaline Phosphatase, ALT, AST
Post-Injection AST · Abnormal
|
0 Participants
|
|
Clinically Significant Change in Serum Chemistries: Alkaline Phosphatase, ALT, AST
Baseline Alkaline Phosphatase · Normal
|
8 Participants
|
|
Clinically Significant Change in Serum Chemistries: Alkaline Phosphatase, ALT, AST
Baseline Alkaline Phosphatase · Abnormal
|
0 Participants
|
|
Clinically Significant Change in Serum Chemistries: Alkaline Phosphatase, ALT, AST
Post-Injection Alkaline Phosphatase · Normal
|
5 Participants
|
|
Clinically Significant Change in Serum Chemistries: Alkaline Phosphatase, ALT, AST
Post-Injection Alkaline Phosphatase · Abnormal
|
0 Participants
|
|
Clinically Significant Change in Serum Chemistries: Alkaline Phosphatase, ALT, AST
Baseline ALT · Normal
|
7 Participants
|
|
Clinically Significant Change in Serum Chemistries: Alkaline Phosphatase, ALT, AST
Baseline ALT · Abnormal
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 hours from 68Ga-Galmydar injectionPopulation: 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).
White blood cell count measured in WBC/mm3 blood. Values outside of laboratory range in comparison to baseline or \>20% difference from baseline values.
Outcome measures
| Measure |
Dosimetry Group
n=8 Participants
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.
|
|---|---|
|
Clinically Significant Change in White Blood Cell Count (WBC)
Baseline WBC · Normal
|
6 Participants
|
|
Clinically Significant Change in White Blood Cell Count (WBC)
Baseline WBC · Abnormal
|
2 Participants
|
|
Clinically Significant Change in White Blood Cell Count (WBC)
Post-Injection WBC · Normal
|
4 Participants
|
|
Clinically Significant Change in White Blood Cell Count (WBC)
Post-Injection WBC · Abnormal
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 hours from 68Ga-Galmydar injectionPopulation: 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).
Hgb measured in g/dL. Values outside of laboratory range in comparison to baseline or \>20% difference from baseline values.
Outcome measures
| Measure |
Dosimetry Group
n=8 Participants
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.
|
|---|---|
|
Clinically Significant Change in Hemoglobin (Hgb)
Baseline Hemoglobin · Normal
|
7 Participants
|
|
Clinically Significant Change in Hemoglobin (Hgb)
Baseline Hemoglobin · Abnormal
|
1 Participants
|
|
Clinically Significant Change in Hemoglobin (Hgb)
Post-Injection Hemoglobin · Normal
|
4 Participants
|
|
Clinically Significant Change in Hemoglobin (Hgb)
Post-Injection Hemoglobin · Abnormal
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 hours from 68Ga-Galmydar injectionPopulation: 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).
Hct measured in %. Values outside of laboratory range in comparison to baseline or \>20% difference from baseline values.
Outcome measures
| Measure |
Dosimetry Group
n=8 Participants
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.
|
|---|---|
|
Clinically Significant Change in Hematocrit (Hct)
Baseline Hematocrit · Normal
|
6 Participants
|
|
Clinically Significant Change in Hematocrit (Hct)
Baseline Hematocrit · Abnormal
|
2 Participants
|
|
Clinically Significant Change in Hematocrit (Hct)
Post-Injection Hematocrit · Normal
|
2 Participants
|
|
Clinically Significant Change in Hematocrit (Hct)
Post-Injection Hematocrit · Abnormal
|
3 Participants
|
SECONDARY outcome
Timeframe: 6 hours from 68Ga-Galmydar injectionPopulation: 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).
Platelets measured in platelets/mm3 blood. Values outside of laboratory range in comparison to baseline or \>20% difference from baseline values.
Outcome measures
| Measure |
Dosimetry Group
n=8 Participants
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.
|
|---|---|
|
Clinically Significant Change in Platelets
Baseline Platelets · Normal
|
8 Participants
|
|
Clinically Significant Change in Platelets
Baseline Platelets · Abnormal
|
0 Participants
|
|
Clinically Significant Change in Platelets
Post-Injection Platelets · Normal
|
5 Participants
|
|
Clinically Significant Change in Platelets
Post-Injection Platelets · Abnormal
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 hours from 68Ga-Galmydar injectionPopulation: 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).
RBC measured in million/mm3. Values outside of laboratory range in comparison to baseline or \>20% difference from baseline values.
Outcome measures
| Measure |
Dosimetry Group
n=8 Participants
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.
|
|---|---|
|
Clinically Significant Change in Red Blood Cell Count (RBC)
Post-Injection RBC · Normal
|
4 Participants
|
|
Clinically Significant Change in Red Blood Cell Count (RBC)
Post-Injection RBC · Abnormal
|
1 Participants
|
|
Clinically Significant Change in Red Blood Cell Count (RBC)
Baseline RBC · Normal
|
7 Participants
|
|
Clinically Significant Change in Red Blood Cell Count (RBC)
Baseline RBC · Abnormal
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 hours from 68Ga-Galmydar injectionPopulation: 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).
MCV measured in µm3. Values outside of laboratory range in comparison to baseline or \>20% difference from baseline values.
Outcome measures
| Measure |
Dosimetry Group
n=8 Participants
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.
|
|---|---|
|
Clinically Significant Change in Mean Corpuscular Volume (MCV)
Baseline MCV · Normal
|
8 Participants
|
|
Clinically Significant Change in Mean Corpuscular Volume (MCV)
Baseline MCV · Abnormal
|
0 Participants
|
|
Clinically Significant Change in Mean Corpuscular Volume (MCV)
Post-Injection MCV · Normal
|
5 Participants
|
|
Clinically Significant Change in Mean Corpuscular Volume (MCV)
Post-Injection MCV · Abnormal
|
0 Participants
|
Adverse Events
Dosimetry Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Pamela K. Woodard
Washington University School of Medicine
Phone: 314-362-7100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place