Medical-AI trial: classifying parkinsonian syndromes from brain imaging (DaTSCAN SPECT) with machine learning — aiding a hard diagnosis (NCT05080296)
An observational study evaluating whether machine learning can distinguish healthy people from Parkinson disease, and idiopathic PD from atypical parkinsonian syndromes, using morphological features from DaTSCAN (ioflupane) SPECT scans of dopamine nerves. Diagnosis of PD relies mainly on clinical observation and can be challenging. The primary outcome is algorithm accuracy. 1,664 cases; completed.
Trial overview (primary data)
- StatusCompleted
- ConditionsDaTSCAN SPECT Scans
- SponsorCentral Hospital, Nancy, France
- Target enrollment1,664 participants
- Period2021-12-20 〜 2024-09-01
Key points
- An observational study of whether ML can distinguish healthy people from PD, and idiopathic PD from atypical syndromes, using features from DaTSCAN (SPECT) dopamine-nerve imaging.
- PD diagnosis relies mainly on clinical symptom observation and can be hard in early or atypical cases.
- ML is framed as potentially aiding early diagnosis and differentiating idiopathic (true) PD from atypical parkinsonian syndromes.
- The primary outcome is algorithm accuracy. 1,664 cases; completed.
- Aiding classification from objective images could support consistency and early judgment; an accuracy evaluation, not an establishment of imaging-diagnosis replacement.
- Diagnosis by observation varies with experience and stage, so 1,664 cases test classification from features quantified out of DaTSCAN images.
1Parkinson's disease and DaTSCAN
Parkinson disease (PD) is a neurological disease in which loss of dopamine nerves in the brain causes tremor, slowed movement, and stiffness. Diagnosis is made mainly by a clinician observing symptoms, but early disease, and telling PD apart from look-alike atypical parkinsonian syndromes, can be hard.
A useful clue is DaTSCAN, a nuclear-medicine imaging test (SPECT) that visualizes the distribution of dopamine transporters in the brain.
2Can machine learning classify the images
This study evaluates, as an observational study, whether machine learning (ML) applied to DaTSCAN images can classify. Per the registry summary, because PD diagnosis relies mainly on clinical observation and is sometimes challenging, ML is framed as potentially helping early diagnosis and differentiating idiopathic (true) PD from atypical parkinsonian syndromes.
Prior research provided a set of imaging features extracted from DaTSCAN (ioflupane, an iodine-123-labeled radiopharmaceutical) SPECT scans, used to discern healthy participants from those with PD. The primary outcome is algorithm accuracy, and the size is 1,664, at the completed stage.
3From observation to numbers
Parkinson's disease is diagnosed largely by a physician observing symptoms, and distinguishing early disease or closely similar syndromes can be difficult. What this study seeks to change is the material on which that judgement rests.
- 1Observe the symptomsDiagnose from tremor, slowness of movement and rigidity
- 2Difficult cases remainEarly disease and atypical parkinsonian syndromes are hard to tell apart
- 3Image itDaTSCAN visualises the distribution of dopamine transporters in the brain
- 4Quantify features and classifyMorphological features extracted from the image separate healthy subjects from PD
The primary endpoint is the accuracy of the algorithm, across 1,664 cases, and the study is complete. Distinguishing true PD from atypical syndromes matters clinically because treatment response and outlook differ. The study evaluates algorithm accuracy and does not establish any replacement for imaging diagnosis or specialist judgement.
Why it matters
Symptom-based diagnosis varies and is hard to be confident about in early or atypical cases. If ML can aid classification from objective, quantified image features, it could support consistency, early judgment, and differentiating disease types that differ in treatment and prognosis (this study is an accuracy evaluation, not an establishment of imaging-diagnosis replacement).
FAQ
What is DaTSCAN (SPECT)?
Can AI confirm a Parkinson diagnosis?
Sources (primary)
Source: ClinicalTrials.gov (U.S. NIH/NLM, public domain). This site does not provide medical advice. Verify the latest and exact details with the official source. This site is not endorsed or certified by the NIH/NLM.
- ClinicalTrials.gov (study record, original)
- NCT ID: NCT05080296