Previous studies showed that a dose of 8 millicuries of Altropane was appropriate for imaging patients with suspected Parkinson's disease. This study determined if a lower dose (5 millicuries) would suffice.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
15
Each participant received a single intravenous (IV) administration of 5 millicuries (mCi) (185 megabecquerels \[MBq\]) of Altropane (123I) Injection on Day 1. Altropane SPECT images were acquired for 30 minutes starting 15 to 20 minutes after administration with Altropane. These images were visually interpreted by 5 expert independent blinded readers.
Johns Hopkins University
Baltimore, Maryland, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Mississippi Medical Center (UMMC)
Jackson, Mississippi, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Striatal Visualization: Percentage of Participants With Correct Majority Classifications of 5-mCi Altropane Images as Determined by 5 Independent Blinded Readers
Assessment of the Altropane SPECT images was performed by 5 independent expert blinded readers to determine striatal uptake, reported as a forced choice of either normal (caudate and putamen fully visible on left and right, or with small insignificant defects) or abnormal (unilateral or bilateral reduced). Majority classification was determined from the majority interpretation of the 5 expert blinded readers (at least 3 of 5 readers).
Time frame: Day 1, up to 30 minutes
Percentage of Participants With Confidence Ratings for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Confidence in Striatal Visualization)
Visual interpretation of the Altropane SPECT images was conducted by 5 independent expert readers who were blinded to each participant's clinical information, and who were not otherwise involved in the study. Their visual image interpretations were a forced choice between normal (caudate and putamen fully visible on left and right, or with small insignificant defects) or abnormal (unilateral or bilateral reduced) striatal uptake. Readers evaluated their confidence in striatal visualization, rating it as high, medium, or low. Majority classification was determined from the majority interpretation of the 5 expert blinded readers (at least 3 of 5 readers) using the high and medium/low groupings. Percentage of participants with confidence ratings for 5-mCi Altropane images are reported.
Time frame: Day 1, up to 30 minutes
Percentage of Participants With Image Quality for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Assessment of Image Quality)
Visual interpretation of the Altropane SPECT images was conducted by 5 independent expert readers who were blinded to each participant's clinical information, and who were not otherwise involved in the study. Their visual image interpretations were a forced choice between normal (caudate and putamen fully visible on left and right, or with small insignificant defects) or abnormal (unilateral or bilateral reduced) striatal uptake. Readers assessed image quality as excellent, good, fair, poor, or unevaluable. Majority classification was determined from the majority interpretation of the 5 expert blinded readers (at least 3 of 5 readers) using the excellent/good and fair/poor/unevaluable groupings. Percentage of participants with image quality for 5-mCi Altropane images are reported.
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Time frame: Day 1, up to 30 minutes
Inter-Reader Agreement on Percentage of Participants With Normal Images
Visual interpretation of the Altropane SPECT images was conducted by 5 independent expert readers who were blinded to each subject's clinical information, and who were not otherwise involved in the study. Their visual image interpretations were a forced choice between normal (caudate and putamen fully visible on left and right, or with small insignificant defects) or abnormal (unilateral or bilateral reduced) striatal uptake. Percentage of participants with inter-reader agreement on striatal visualization classification for whom 5, 4, and 3 readers, respectively, were in agreement on the participants classification (normal images) are reported.
Time frame: Day 1, up to 30 minutes
Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs)
An Adverse Event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product, which did not necessarily have a causal relationship with the treatment. Treatment-Emergent Adverse Events (TEAEs) were defined as AEs that started or worsened between the start of pharmaceutical product administration and the end of the follow-up period.
Time frame: From administration of Altropane until 24 hours post dose
Percentage of Participants With Adverse Drug Reaction (ADR)
ADR is an AE that is caused by the investigational medicinal product.
Time frame: From administration of Altropane until 24 hours post dose
Percentage of Participants With Clinically Significant Changes From Baseline in Vital Signs
Percentage of participants with clinically significant changes from baseline in vital signs (systolic and diastolic blood pressure, heart rate, respiratory rate, and temperature). Normal limits of vital signs are: 1. Systolic BP (mmHg) - low: 85 and High: 139; Diastolic BP (mmHg) - low: 60 and High: 89. 2. Heart rate (bpm) - low: 60 and High: 100. 3. Respiration Rate (rpm) - low: 12 and High: 22. 4. Body Temperature - low: 36.4 degree Celsius (97.5 degree Fahrenheit) and High: 37.7 degree Celsius (99.5 degree Fahrenheit).
Time frame: From administration of Altropane until 24 hours post dose
Percentage of Participants With Clinically Significant Changes From Baseline in Physical Examination Until 24 Hours Post Dose
Percentage of participants with clinically significant changes from baseline in physical examination (general appearance, lungs and heart).
Time frame: From administration of Altropane until 24 hours post dose
Percentage of Participants With Clinically Significant Changes From Baseline in Electrocardiogram (ECG) Examinations (PR Interval, QTc, QRS and RR Interval) Until 24 Hours Post Dose
Percentage of participants with clinically significant changes from baseline in electrocardiogram (ECG) examinations: (PR interval, QTc, QRS and RR interval). The normal limits (ms) of ECG variables: 1. PR interval (ms) - low: 120 and high: 200 2. QRS interval (ms) - low: 50 and high: 100 3. QTc interval (ms)- high =\<440 4. RR interval (ms) - low: 600 and high: 1000
Time frame: From administration of Altropane until 24 hours post dose
Percentage of Participants With Clinically Significant Changes From Baseline in Serum Biochemistry and Hematology Parameters Until 24 Hours Post Dose
Percentage of participants with clinically significant changes from baseline in serum biochemistry (Alanine aminotransferase, Albumin, Alkaline phosphatase, Bicarbonate, Creatine phosphokinase (CPK), total Creatinine, Protein (total), Phosphorous Glucose) and hematology parameters (Red blood cell (RBC) count, Platelet count, White blood cell (WBC) count).
Time frame: From administration of Altropane until 24 hours post dose