Evaluation of diagnostic performances of 18F-FDOPA PET KInetics as biomarkers for the improvement of care of MRI Non-contrast enhanced Gliomas : a phase IIIb exploratory trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Regional Universitaire De Nancy

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

24 May 2023 → ongoing

Decision date (initial)

2023-04-14

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

French national oncologic program (InCA et DGOS) · Centre Hospitalier Regional Universitaire De Nancy · Curium Pet France

External identifiers

EU CT number

2022-501688-42-00

ClinicalTrials.gov

NCT05512403

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

To assess diagnostic performances of 18F-FDOPA PET Time-To-Peak (TPP) in suspected LGGs without MRI -contrast enhancement for characterisation of aggressive lesions defined as high histopathological grade (3 or 4) or dismal molecular characteristics (CDKN2A/B deletion in IDH-mutant astrocytomas, molecular features of glioblastoma in IDH-wildtype gliomas) by the pathology analyses performed within 6 months post-inclusion.

Secondary objectives 4

1. The diagnostic performances of 18F-FDOPA "slope", to characterise aggressive lesions.
2. The diagnostic performances of 18F-FDOPA SUV static conventional parameters and/or radiomics analyses associated with TTP kinetic parameter, to characterise aggressive lesions.
3. The prevalence of aggressive forms within the suspected LGGs without any MRI contrast enhancement.
4. The clinical impact of the 18F-FDOPA PET kinetic TTP parameter.

Conditions and MedDRA coding

Low Grade Glioma

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Age between 18 and 75 years old
2. WHO general condition ≤2
3. Identification of an unifocal brain tumour at the initial diagnosis with no contrast in the MRI and suspected to be a LGG, with biopsy/surgery envisaged within 6 months of the PET scan/CT
4. MRI performed a maximum of 3 weeks before inclusion and comprising the conventional morphological sequences (T1, T1 sequences with injection of contrast agent and T2 FLAIR).
5. Subject affiliated to or beneficiary of a social security plan
6. Subject having received complete information on the organisation of the research and having signed the informed consent form.

Exclusion criteria 7

1. Multifocal brain lesions
2. Contraindication to 18F-FDOPA PET
3. Concomitant treatment by Carbidopa, Halopéridol, Réserpine and MAOIs.
4. Pregnant, parturient women or nursing mothers under Article L1121-5
5. Women of childbearing age who do not have effective contraception under Article L1121-5
6. Monitoring not possible
7. Persons deprived of their liberty by a judicial or administrative decision under Article 1121-8, persons undergoing psychiatric treatment under Articles L. 3212-1 and L. 3213-1

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoints are: the sensitivity, specificity, predictive positive value (PPV) and negative predictive value (NPV) of the 18F-FDOPA kinetic TTP parameter, to characterise aggressive lesions within suspected LGGs with no contrast enhancement on MRI at the initial diagnosis.

Secondary endpoints 4

1. Sensitivity, specificity, PPV and NPV of the 18F-FDOPA kinetic “slope” parameter.
2. Sensitivity, specificity, PPV and NPV of the 18F-FDOPA SUV conventional parameters (SUVmax, SUVmean and SUVpeak) and/or radiomics analysis (with the best predictive radiomics model) associated to the TTP kinetic parameter.
3. Proportion of aggressive lesions expressed as an instantaneous prevalence and its 95% confidence interval of the total number of suspected LGGs without any contrast enhancement on MRI examined at initial diagnosis and referred for biopsy or surgery within the following 6 months
4. Number of patients who need to be diagnosed with 18F-FDOPA kinetic parameter TTP to identify an aggressive lesion within the suspected LGG population that do not exhibit any contrast enhancement on MRI at initial diagnosis and that undergo biopsy/surgery, defined as: 1/ [% of aggressive lesions detected with the 18F-FDOPA TTP parameter].

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Regional Universitaire De Nancy

Sponsor organisation

Centre Hospitalier Regional Universitaire De Nancy

Address

Co N°34, 29 Av Du Mal De Lattre De Tassigny 29 Av Du Mal De Lattre De Tassigny

City

Nancy Cedex

Postcode

54035

Country

France

Scientific contact point

Organisation

Centre Hospitalier Regional Universitaire De Nancy

Contact name

Coordinating project manager

Public contact point

Organisation

Centre Hospitalier Regional Universitaire De Nancy

Contact name

Principal Investigator

Locations

1 EU/EEA country · 12 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 9 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