Altropane Dose for Imaging Patients With Suspected Parkinson's Disease

Phase 2

Terminated

Conditions: Parkinson Disease
Movement Disorders

Interventions: Drug: Altropane (123I) Injection

Registration Number: NCT05636852

Lead Sponsor: GE Healthcare

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 15

Inclusion Criteria

For Part 1: a) the participant had a DaTscan image, obtained within 1 year (preferably within 6 months) before screening, that showed normal striatal uptake and b) the participant had a clinical diagnosis (made by a board-certified neurologist who was qualified by training and experience in the diagnosis of movement disorders) that was consistent with the DaTscan image.

For Part 2 (which was not conducted): a) the participant had a DaTscan image, obtained within 1 year (preferably within 6 months) before screening, that showed abnormal (unilateral or bilateral reduced) striatal uptake and b) the participant also had a confirmed clinical diagnosis of a dPS (such as Parkinson's disease, multiple system atrophy, corticobasal degeneration, progressive supranuclear palsy, etc.) made by a board-certified neurologist who was qualified by training and experience in the diagnosis of movement disorders, and c) the diagnosis was consistent with the DaTscan image.

The participant was male or female, ≥18 years of age, of any race and ethnicity.
The participant was able and willing to comply with study procedures and signed and dated informed consent was obtained.
If the participant was a woman of childbearing potential*, she must have used a highly effective method of contraception** from Screening until 30 days after the last administration of Altropane, and the results of a serum or urine human chorionic gonadotropin (hCG) pregnancy test, performed at Screening and on the day of Altropane administration (with the result known before Altropane administration), must have been negative.

* A woman of childbearing potential was defined as neither post-menopausal nor surgically sterile. Post-menopausal means having had no menses for at least 12 months without an alternative medical cause. Surgically sterile means having had a documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy, or any combination of these.

** A highly effective method of contraception was defined as one that had a failure rate of less than 1% per year when used consistently and correctly; such methods included combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable); intrauterine device; intrauterine hormone-releasing system; bilateral tubal ligation/occlusion; vasectomized partner (with medical confirmation of success); and abstinence from heterosexual intercourse involving a woman of childbearing potential.
If the participant was a male*** with a sexual partner who was a woman of childbearing potential*, he and his partner must have used adequate contraception** from Screening until 30 days after the last administration of Altropane.

(***A male was considered fertile after puberty unless permanently sterile by bilateral orchidectomy, or vasectomized with confirmation of success.)

Exclusion Criteria

The participant was previously included in this study.
Fewer than 7 disintegration half-lives had elapsed between the participant's last procedure (therapeutic or diagnostic) involving a radioisotope and Visit 2 (altropane SPECT imaging).
Including participation in this study, the participant's total exposure to radiation during medical procedures/tests in the past year would have exceeded 50 mSv.
The participant had participated in an investigational drug or device clinical trial within 30 days before the date of informed consent.
The participant had any clinically significant or unstable physical or psychological illness, structural brain abnormality, abnormal laboratory results, or abnormal ECG (based on medical history or physical examination at Screening), as determined by the Principal Investigator, that would interfere with study participation.
The participant had any history of drug or alcohol abuse in the 2 years prior to the date of informed consent.
The participant had a positive urine screen for drugs of abuse at Screening.
The participant was a pregnant or breast-feeding female, or was a female of child-bearing potential that was not using appropriate birth control.
The participant was unable to lie supine for 1 hour.
The participant had any thyroid disease other than adequately treated hypothyroidism.
The participant had known or suspected allergy/hypersensitivity to any ingredient in Altropane or to the thyroid blocking medication to be used before imaging.
The participant was taking any of the medications/treatments listed in the protocol as disallowed and could not or would not discontinue use at least 12 hours prior to SPECT exam.
The participant was referred to DaTscan imaging for evaluation of possible cognitive impairment including dementia.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Altropane (123I) Injection	Altropane (123I) Injection	-

Primary Outcome Measures

Name	Time	Method
Striatal Visualization: Percentage of Participants With Correct Majority Classifications of 5-mCi Altropane Images as Determined by 5 Independent Blinded Readers	Day 1, up to 30 minutes	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).

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Confidence Ratings for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Confidence in Striatal Visualization)	Day 1, up to 30 minutes	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.
Percentage of Participants With Image Quality for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Assessment of Image Quality)	Day 1, up to 30 minutes	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.
Inter-Reader Agreement on Percentage of Participants With Normal Images	Day 1, up to 30 minutes	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.
Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs)	From administration of Altropane until 24 hours post dose	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.
Percentage of Participants With Adverse Drug Reaction (ADR)	From administration of Altropane until 24 hours post dose	ADR is an AE that is caused by the investigational medicinal product.
Percentage of Participants With Clinically Significant Changes From Baseline in Vital Signs	From administration of Altropane until 24 hours post dose	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).
Percentage of Participants With Clinically Significant Changes From Baseline in Physical Examination Until 24 Hours Post Dose	From administration of Altropane until 24 hours post dose	Percentage of participants with clinically significant changes from baseline in physical examination (general appearance, lungs and heart).
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	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). 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
Percentage of Participants With Clinically Significant Changes From Baseline in Serum Biochemistry and Hematology Parameters Until 24 Hours Post Dose	From administration of Altropane 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).

Trial Locations

Locations (4): 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
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States