New PET/CT for (possible) cardiac sarcoidosis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Decision date (initial)

2026-02-12

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Funding sources

Erasmus MC

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

To evaluate the accuracy of 68Ga-Pentixafor PET/CT in imaging CS in a pilot study.

Secondary objectives 4

1. Pathological myocardial tracer uptake
2. Physiological myocardial uptake
3. Interobserver agreement for 68Ga-Pentixafor PET/CT.
4. Uptake in other organs affected by sarcoidosis

Conditions and MedDRA coding

Cardiac Sarcoidosis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Adult patients (aged 18 years or older)
2. Consensus diagnosis of extracardiac sarcoidosis
3. Patients with (suspected) cardiac sarcoidosis referred for a clinically indicated 18F-FDG PET/CT

Exclusion criteria 4

1. Medical history of other known cardiac infectious or inflammatory disease
2. (Possible) pregnancy in pre-menopausal women
3. Refusal to be informed about potential additional PET/CT findings.
4. Inability to provide informed consent

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Sensitivity and specificity of 68Ga-Pentixafor PET/CT in patients with (suspected) cardiac sarcoidosis. Standard of care 18F-FDG PET/CT is the reference test.

Secondary endpoints 7

1. The amount of 68Ga-Pentixafor uptake in the myocardium is scored by the Qualification Visual Score for Hypermetabolism (QVSH) o 0 = None (no or less uptake than in the mediastinum) o 1 = Mild (more uptake than in the mediastinum, less than in the liver) o 2 = Moderate (more uptake than in the liver) o 3 = Severe (intense uptake)
2. In case of abnormal uptake the pattern (focal, focal on diffuse or diffuse), extent, and exact location(s) of uptake is described for the left and right ventricle(19). Scoring for the uptake pattern is as follows: o 1 = No uptake o 2 = Diffuse uptake o 3 = Focal uptake o 4 = Focal on diffuse uptake If the uptake in the myocardium is focal or focal on diffuse, the location is scored according to a validated LV segmental scoring system(20).
3. The standardized uptake values (SUV) is scored for quantitative assessment of tracer uptake(19).
4. Myocardial suppression will be scored as: • Fully suppressed (no uptake) • Low (more than mediastinal, less than liver) • Intermediate (more than liver uptake) • High focal (much more than liver, focal) • High diffuse (much more than liver, diffuse)
5. Two experienced observers will analyze the images, and findings will be compared.
6. Presence of uptake in other organs suspected for sarcoidosis will be scored, including information on the affected organ.
7. Time-activity curves will be used to study perfusion characteristics of the tracer.

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Sponsor organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Address

Dr. Molewaterplein 40

City

Rotterdam

Postcode

3015 GD

Country

Netherlands

Scientific contact point

Organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Contact name

Alexander Hirsch

Public contact point

Organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Contact name

Daniel Bos

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

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

Documents 5 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