Positron emission tomography (PET) of patients with brain injury and athletes with concussion symptoms - Descriptive study of the tau tracer 18F-RO6958948

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Skane

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Trial duration

21 Apr 2021 → ongoing

Decision date (initial)

2024-09-20

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-517048-67-00

EudraCT number

2020-002433-15

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

The primary objective is to study if tau is increased in the brain compared to the normal population and where in the brain the uptake occures.

Secondary objectives 1

1. To correlate the uptake of tau in the brain with levels of tau in the blood, and is it possible to follow tau in the brain with blood samples?

Conditions and MedDRA coding

Cerebral commotio

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. The subject/patient has given his written consent to participate in the study.
2. Age 18-60 years.
3. The patient is judged by the investigator to be clinically stable enough to pass the examination with PET, and understand the study information.
4. Study population A-C (patients with TBI, ICH or SAH): Cared for in the intensive care unit NIVA with one of the diagnoses traumatic brain injury (TBI), intracerebral haemorrhage (ICH) or subarachnoid haemorrhage (SAH). During the care period, relatives have been informed and did not object to participation.
5. Study population D (athletes): Athletes age 18-40 years, The athlete has suffered from at least one previous concussion in sports and has persistent symptoms, The athlete must have had symptoms (post-emotional syndrome) for at least 6 months after the last concussion.

Exclusion criteria 5

1. Claustrophobia.
2. Pregnancy, breast-feeding or planned pregnancy.
3. Mental inability, reluctance or language difficulties that make it difficult to understand the meaning of participating in the study.
4. Treatment or illness which, according to the examiner, may affect the treatment or the study result.
5. Participates in or has recently participated in a clinical trial in the last 6 months.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Uptake of the PETtracer measured at PET examination.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Skane

Sponsor organisation

Region Skane

Address

Dockplatsen 26, Malmo S:t Petri Malmo S:t Petri

City

Malmo

Postcode

211 74

Country

Sweden

Scientific contact point

Organisation

Region Skane

Contact name

Niklas Marklund

Public contact point

Organisation

Region Skane

Contact name

Niklas Marklund

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications