Clinical trial NCT05636852: Altropane Dose for Imaging Patients With Suspected Parkinson's Disease
Official title: An Open-label Multicenter Phase 2 Dose-evaluation Study of Altropane (123I) Injection for Striatal Dopamine Transporter Visualization Using SPECT Brain Imaging
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Parkinson Disease
Movement Disorders
Keywords: SPECT
Altropane
Parkinson's disease
Parkinsonian syndromes
movement disorders
striatum
dopamine transporter
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Fortrea
First posted: 2022-12-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

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 will determine if a lower dose (5 millicuries) would suffice.


Eligibility criteria: 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.

Primary outcomes:
measure: Striatal uptake
timeFrame: 30 days
Secondary outcomes:
measure: Reader confidence
timeFrame: 30 days
measure: Reader Assessment of Image Quality
timeFrame: 30 days
measure: Inter-reader agreement
timeFrame: 30 days
measure: Altropane-related Serious Adverse Events
timeFrame: From administration of Altropane until 24 hours post dose
measure: Treatment-Emergent Adverse Events
timeFrame: From administration of Altropane until 24 hours post dose
measure: Adverse Events
timeFrame: From administration of Altropane until 24 hours post dose
measure: Number of participants with abnormal serum biochemistry laboratory test results.
timeFrame: Baseline (pre-Altropane) and within 60 minutes after imaging.
measure: Number of participants with abnormal hematology laboratory test results.
timeFrame: Baseline (pre-Altropane) and within 60 minutes after imaging.
measure: Number of participants with abnormal systolic and diastolic blood pressure (in millimeters of mercury [mmHg]).
timeFrame: Baseline (pre-Altropane) and within 60 minutes after imaging.
measure: Number of participants with abnormal body temperature (degrees Celsius).
timeFrame: Baseline (pre-Altropane) and within 60 minutes after imaging.
measure: Number of participants with abnormal heart rate (beats per minute [bpm]).
timeFrame: Baseline (pre-Altropane) and within 60 minutes after imaging.
measure: Number of participants with abnormal respiratory rate (breaths per minute)
timeFrame: Baseline (pre-Altropane) and within 60 minutes after imaging.
measure: Number of participants with abnormal electrocardiogram (ECG) examinations (PR interval, QTc, QRS and RR interval).
timeFrame: Baseline (pre-Altropane) and within 60 minutes after imaging.
measure: Number of participants with abnormal physical examination (general appearance, lungs and heart) findings.
timeFrame: Baseline (pre-Altropane) and within 60 minutes after imaging.
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center (UMMC)
state: Mississippi
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: GE Healthcare
name: Paul Sherwin, MD, PhD
role: STUDY_DIRECTOR
References: