Altropane Dose for Imaging Patients With Suspected Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

An Open-label Multicenter Phase 2 Dose-evaluation Study of Altropane (123I) Injection for Striatal Dopamine Transporter Visualization Using SPECT Brain Imaging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05636852
• Other study ID #: GE-278-001
• Status: Recruiting
• Phase: Phase 2
• Start date: April 24, 2023
• Est. completion date: March 29, 2024

Study information

• Verified date: February 2024
• Source: GE Healthcare
• Contact: Jessica Clancy
• Phone: (978) 243-7447
• Email: Jessica.Clancy[@]ge.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Previous studies showed that a dose of 8 millicuries of Altropane was appropriate for imaging patients with suspected Parkinson's disease. This study will determine if a lower dose (5 millicuries) would suffice.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 29, 2024
• Est. primary completion date: March 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

For Part 2 (if applicable): a) the patient has a DaTscan image, obtained within 1 year (preferably within 6 months) before screening, that shows abnormal (unilateral or bilateral reduced) striatal uptake and b) the patient also has 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 is qualified by training and experience in the diagnosis of movement disorders, and c) the diagnosis is consistent with the DaTscan image.

• The patient is male or female, =18 years of age, of any race and ethnicity.

• The patient is able and willing to comply with study procedures and signed and dated informed consent is obtained.

• If the patient is a woman of childbearing potential*, she must use 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 be negative.

• A woman of childbearing potential is 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 is one that has a failure rate of less than 1% per year when used consistently and correctly; such methods include 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 patient is a male*** with a sexual partner who is a woman of childbearing potential*, he and his partner must use adequate contraception** from Screening until 30 days after the last administration of Altropane.

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

Exclusion Criteria:

• The patient was previously included in this study.

• Fewer than 7 disintegration half-lives have elapsed between the patient's last procedure (therapeutic or diagnostic) involving a radioisotope and Visit 2 (altropane SPECT imaging).

• Including participation in this study, the patient's total exposure to radiation during medical procedures/tests in the past year would exceed 50 mSv.

• The patient has participated in an investigational drug or device clinical trial within 30 days before the date of informed consent.

• The patient has 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 patient has any history of drug or alcohol abuse in the 2 years prior to the date of informed consent.

• The patient has a positive urine screen for drugs of abuse at Screening.

• The patient is a pregnant or breast-feeding female, or is a female of child-bearing potential that is not using appropriate birth control.

• The patient is unable to lie supine for 1 hour.

• The patient has any thyroid disease other than adequately treated hypothyroidism.

• The patient has known or suspected allergy/hypersensitivity to any ingredient in Altropane or to the thyroid blocking medication to be used before imaging.

• The patient is currently taking any of the medications/treatments listed in the protocol as disallowed and cannot or will not discontinue use at least 12 hours prior to SPECT exam.

• The patient was referred to DaTscan imaging for evaluation of possible cognitive impairment including dementia.

Related Conditions & MeSH terms

• Movement Disorders
• Parkinson Disease

Intervention

Drug:
• Altropane (123I) Injection
Each subject will receive a single IV administration of 5 mCi (185 MBq) Altropane.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Mississippi Medical Center (UMMC)	Jackson	Mississippi
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
GE Healthcare	Fortrea, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Striatal uptake	Assessment of the Altropane SPECT images 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).	30 days
Secondary	Reader confidence	Reader confidence in striatal visualization, rating it as high, medium, or low	30 days
Secondary	Reader Assessment of Image Quality	Each subject's image quality will be rated as excellent, good, fair, poor, or unevaluable.	30 days
Secondary	Inter-reader agreement	Number and percentage of images for which 5, 4, and 3 readers, respectively, are in agreement on the subject classification for Part 1, and, if applicable, Part 2.	30 days
Secondary	Altropane-related Serious Adverse Events		From administration of Altropane until 24 hours post dose
Secondary	Treatment-Emergent Adverse Events		From administration of Altropane until 24 hours post dose
Secondary	Adverse Events		From administration of Altropane until 24 hours post dose
Secondary	Number of participants with abnormal serum biochemistry laboratory test results.	Baseline is the last observation prior to administration of Altropane. The occurrence of post-injection values outside of normal limits and changes from baseline will be summarized.	Baseline (pre-Altropane) and within 60 minutes after imaging.
Secondary	Number of participants with abnormal hematology laboratory test results.	Baseline is the last observation prior to administration of Altropane. The occurrence of post-injection values outside of normal limits and changes from baseline will be summarized.	Baseline (pre-Altropane) and within 60 minutes after imaging.
Secondary	Number of participants with abnormal systolic and diastolic blood pressure (in millimeters of mercury [mmHg]).	Baseline is the last observation prior to administration of Altropane. The occurrence of post-injection values outside of normal limits and changes from baseline will be summarized.	Baseline (pre-Altropane) and within 60 minutes after imaging.
Secondary	Number of participants with abnormal body temperature (degrees Celsius).	Baseline is the last observation prior to administration of Altropane. The occurrence of post-injection values outside of normal limits and changes from baseline will be summarized.	Baseline (pre-Altropane) and within 60 minutes after imaging.
Secondary	Number of participants with abnormal heart rate (beats per minute [bpm]).	Baseline is the last observation prior to administration of Altropane. The occurrence of post-injection values outside of normal limits and changes from baseline will be summarized.	Baseline (pre-Altropane) and within 60 minutes after imaging.
Secondary	Number of participants with abnormal respiratory rate (breaths per minute)	Baseline is the last observation prior to administration of Altropane. The occurrence of post-injection values outside of normal limits and changes from baseline will be summarized.	Baseline (pre-Altropane) and within 60 minutes after imaging.
Secondary	Number of participants with abnormal electrocardiogram (ECG) examinations (PR interval, QTc, QRS and RR interval).	Baseline is the last observation prior to administration of Altropane. The occurrence of post-injection values outside of normal limits and changes from baseline will be summarized.	Baseline (pre-Altropane) and within 60 minutes after imaging.
Secondary	Number of participants with abnormal physical examination (general appearance, lungs and heart) findings.	Baseline is the last observation prior to administration of Altropane. The occurrence of post-administration physical exam status values outside the normal limits will be summarized.	Baseline (pre-Altropane) and within 60 minutes after imaging.