Comparison of 18F-Fluciclovine PET versus 18F-Fluoroethyltyrosine PET in patients with newly diagnosed cerebral gliomas, recurrent cerebral gliomas and brain metastases – an open label single centre single arm prospective basket trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitaetsklinikum Aachen AöR

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

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

Trial duration

14 Aug 2024 → 2 Apr 2026

Decision date (initial)

2024-03-11

Transition trial

No

Low-intervention

Yes

Rare-disease indication

Yes

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

Assessment of agreement on tumour size and tracer distribution in FET PET and FACBC PET in the examined patients.

Secondary objectives 4

1. Determine the correlation of the tumour-to-brain ratios in FET and FACBC PET.
2. Determine the difference of FET to FACBC uptake with respect of Time-to-peak (TTP) or slope of the time-activitycurve (TAC) in high-grade and low-grade gliomas.
3. Determine accuracy of FET to FACBC PET in differentiating tumour progression (TP) and treatment related changes (TRC) in recurrent gliomas and brain metastases.
4. Determine difference of FET to FACBC PET with respect to TTP and slope of the TAC of FET and FACBC uptake in TP and TRC in recurrent gliomas and brain metastases.

Conditions and MedDRA coding

Patients with newly diagnosed cerebral gliomas, recurrent cerebral gliomas and brain metastases.

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Patient is ≥ 18 years old.
2. Patient is mentally and physically able to understand the significance and scope of the study and to comply with the study staff.
3. Patient has decision-making capacity: capable of giving consent, insight, and information.
4. Patient has signed a written informed consent form prior to participation in the study.
5. Patient is referred to the Nuclear Medicine Clinic of the University Hospital Aachen for FET PET of the brain based on the prescription of the treating physicians.
6. Patient has suspected glioma prior to biopsy or surgery. OR
7. Patient has suspected tumour recurrence after previous treatment for cerebral glioma or brain metastasis.

Exclusion criteria 6

1. Patient is pregnant or breastfeeding.
2. Patient is not willing to take adequately safe contraceptive measures.
3. Patient is institutionalised due to official or court order.
4. Patient is in a dependent relationship or employment relationship with the sponsor, investigator or his or her deputy.
5. Patient has insufficiently controlled epilepsy.
6. Patient is unable to lie still for 40 minutes.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is the agreement of the diagnosis of tumour size and tracer distribution in FET PET with FACBC PET in the examined patients based on consensus voting in the classification categories A or B by three examiners. Categories C and D will be assessed as disagreement.

Secondary endpoints 4

1. Significant correlation of the tumour-to-brain ratios in FET and FACBC PET.
2. Similar differences of Time-to-peak (TTP) and slope of the time-activity-curve (TAC) of FET and FACBC uptake in highgrade and low-grade gliomas.
3. Similar accuracy of FET and FACBC PET in differentiating tumour progression (TP) and treatment related changes (TRC) in recurrent gliomas and brain metastases.
4. Similar differences of TTP and slope of the TAC of FET and FACBC uptake in TP and TRC in recurrent gliomas and brain metastases.

Investigational products

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

Test 2

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitaetsklinikum Aachen AöR

Sponsor organisation

Universitaetsklinikum Aachen AöR

Address

Pauwelsstrasse 30

City

Aachen

Postcode

52074

Country

Germany

Scientific contact point

Organisation

Universitaetsklinikum Aachen AöR

Contact name

Prof. Dr. med. Karl Josef Langen

Public contact point

Organisation

Universitaetsklinikum Aachen AöR

Contact name

Dr. Rainer Schuckelt

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 11 files

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

Application history

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