Parkinson DiseasePhase 2NCT05636852
Altropane Dose for Imaging Patients With Suspected Parkinson's Disease
A Phase 2 study testing Altropane (123I) Injection in people with Parkinson Disease and Movement Disorders, run by GE Healthcare at 4 sites in United States.
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 determined if a lower dose (5 millicuries) would suffice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Movement Disorders
- What is being tested?
- Altropane (123I) Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 4 sitesUnited States
- Study dates
- 24 Apr 2023to 8 Jun 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins University
Baltimore, Maryland, 21287
University of Mississippi Medical Center (UMMC)
Jackson, Mississippi, 39216
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: An Open-label Multicenter Phase 2 Dose-evaluation Study of Altropane (123I) Injection for Striatal Dopamine Transporter Visualization Using SPECT Brain Imaging
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.
- Conditions
- Parkinson Disease, Movement Disorders
- Being tested
- Altropane (123I) Injection
- Keywords
- SPECT, Altropane, Parkinson's disease, Parkinsonian syndromes, movement disorders, striatum, dopamine transporter
- Medical subject headings
- Parkinson Disease, Movement Disorders, Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Altropane (123I) InjectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Altropane (123I) Injection | Experimental | Not described Receives: Drug: Altropane (123I) Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 1, up to 30 minutes
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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:
- Systolic BP (mmHg) - low: 85 and High: 139; Diastolic BP (mmHg) - low: 60 and High: 89.
- Heart rate (bpm) - low: 60 and High: 100.
- Respiration Rate (rpm) - low: 12 and High: 22.
- Body Temperature - low: 36.4 degree Celsius (97.5 degree Fahrenheit) and High: 37.7 degree Celsius (99.5 degree Fahrenheit).
Measured: 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).
Measured: 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:
- PR interval (ms) - low: 120 and high: 200
- QRS interval (ms) - low: 50 and high: 100
- QTc interval (ms)- high =<440
- RR interval (ms) - low: 600 and high: 1000
Measured: 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).
Measured: From administration of Altropane until 24 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start24 Apr 2023
- Primary completion8 Jun 2024
- Study completion8 Jun 2024
Why it stopped: Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fortrea
- Responsible party
- Sponsor
- Investigators
- Paul Sherwin, MD, PhD, Study director, GE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636852
- Sponsor's protocol ID
- GE-278-001
- Status last verified
- Jun 2025
- First submitted
- 1 Nov 2022
- Last updated
- 15 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Multicenter Phase 2 Dose-evaluation Study of Altropane (123I) Injection for Striatal Dopamine Transporter Visualization Using SPECT Brain Imaging
- ClinicalTrials.gov ID
- NCT05636852
- Acronym / sponsor ID
- GE-278-001
- Conditions
- Parkinson Disease, Movement Disorders
- Keywords
- SPECT, Altropane, Parkinson's disease, Parkinsonian syndromes, movement disorders, striatum, dopamine transporter
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business Decision
- Enrolment
- 15 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Fortrea
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 8 Jun 2024 (actual)
- Study completion
- 8 Jun 2024 (actual)
- First posted
- 5 Dec 2022 (actual)
- Results
- Posted 15 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Altropane (123I) Injection | Experimental | Drug: Altropane (123I) Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Altropane (123I) InjectionEach 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. | Drug | Altropane (123I) Injection |
Primary outcome
Striatal Visualization: Percentage of Participants With Correct Majority Classifications of 5-mCi Altropane Images as Determined by 5 Independent Blinded Readers
Time frame: 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).
9 secondary outcomes
Percentage of Participants With Confidence Ratings for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Confidence in Striatal Visualization)
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)
Time frame: Day 1, up to 30 minutes
Inter-Reader Agreement on Percentage of Participants With Normal Images
Time frame: Day 1, up to 30 minutes
Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs)
Time frame: From administration of Altropane until 24 hours post dose
Percentage of Participants With Adverse Drug Reaction (ADR)
Time frame: From administration of Altropane until 24 hours post dose
Percentage of Participants With Clinically Significant Changes From Baseline in Vital Signs
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
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
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
Time frame: From administration of Altropane until 24 hours post dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Sherwin, MD, PhD study director
GE Healthcare
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Altropane (123I) Injection in people with Parkinson Disease and Movement Disorders, run by GE Healthcare at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Striatal Visualization: Percentage of Participants With Correct Majority Classifications of 5-mCi Altropane Images as Determined by 5 Independent Blinded Readers (time frame: Day 1, up to 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.