Comparison of 18F-Fluciclovine PET versus 18F-FluoroethyltyrosinePET in patients with newly diagnosed cerebral gliomas, recurrentcerebral gliomas and brain metastases – an open label single centresingle arm prospective basket trial
- Conditions
- Patients with newly diagnosed cerebral gliomas, recurrent cerebral gliomas and brain metastases.MedDRA version: 20.0Level: LLTClassification code: 10006128Term: Brain metastases Class: 10029104MedDRA version: 20.0Level: PTClassification code: 10018338Term: Glioma Class: 100000004864Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Registration Number
- CTIS2023-507786-26-00
- Lead Sponsor
- niversitaetsklinikum Aachen AöR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 240
Patient is = 18 years old., Patient is mentally and physically able to understand the significance and scope of the study and to comply with the study staff., Patient has decision-making capacity: capable of giving consent, insight, and information., Patient has signed a written informed consent form prior to participation in the study., 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., Patient has suspected glioma prior to biopsy or surgery. OR, Patient has suspected tumour recurrence after previous treatment for cerebral glioma or brain metastasis.
Patient is pregnant or breastfeeding., Patient is not willing to take adequately safe contraceptive measures., Patient is institutionalised due to official or court order., Patient is in a dependent relationship or employment relationship with the sponsor, investigator or his or her deputy., Patient has insufficiently controlled epilepsy., Patient is unable to lie still for 40 minutes.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Assessment of agreement on tumour size and tracer distribution in FET PET and FACBC PET in the examined patients.;Secondary Objective: Determine the correlation of the tumour-to-brain ratios in FET and FACBC PET., 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., Determine accuracy of FET to FACBC PET in differentiating tumour progression (TP) and treatment related changes (TRC) in recurrent gliomas and brain metastases., 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.;Primary end point(s): 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 Outcome Measures
Name Time Method Secondary end point(s):Significant correlation of the tumour-to-brain ratios in FET and FACBC PET.;Secondary end point(s):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.;Secondary end point(s):Similar accuracy of FET and FACBC PET in differentiating tumour progression (TP) and treatment related changes (TRC) in recurrent gliomas and brain metastases.;Secondary end point(s):Similar differences of TTP and slope of the TAC of FET and FACBC uptake in TP and TRC in recurrent gliomas and brain metastases.