Contribution of Cerebral 18F-DOPA PET-CT Scan in High-grade Recurrent Gliomas

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Contribution of Cerebral 18F-DOPA PET-CT Scan in High-grade Recurrent Gliomas

Study Purpose

High-grade gliomas represent 60 to 70% of adult glial tumors and are highly aggressive with average survival from 12 to 15 months for glioblastomas (WHO grade IV gliomas) and from 2 to more than 5 years for WHO grade III gliomas. The treatment of initial stage high-grade gliomas is made with the most complete excision surgery possible followed by adjuvant radiochemotherapy or an exclusive radiochemotherapy if excision is impossible. Most often, these treatments are followed by adjuvant chemotherapy. Treatment of recurrence is most often re-irradiation according to stereotaxic modalities. Determination of the volumes to be irradiated conditions effectiveness and tolerance in the planning of these treatments. The definition of Gross Tumor Volume (GTV) is based on enhancing

- T1 magnetic resonance imaging (MRI) after gadolinium injection.

A margin of 1-2 mm is applied to define the PTV (Planning Target Volume) or irradiated volume, approximately equal to the GTV-MRI. Amino acid PET-CT (Positon Emission Tomography with Computed Tomography) could be an interesting alternative to tumor delineation because its results, do not depend on the rupture of the blood-brain barrier. Several studies have used amino acid PET in the planning of radiotherapy treatment for high-grade gliomas, but without a well-conducted prospective study. In the recurrent high-grade glioma population, no studies have been performed with 18F-DOPA.( 6-fluoro-[18F]-L-dihydroxyphenylalanine) The question therefore relates to the interest of cerebral 18F-DOPA PET-CT to improve the delineation of the volumes to be re-irradiated, during the recurrence of high-grade gliomas, and on the optimal methodology for determining GTV- PET. To compare GTV-TEP and GTV-MRI volumes with each other, and the r-GTV, volume corresponding to the relapse objectified on the follow-up MRI, the analysis will be based on 3 parameters:

- DICE index, similarity index between 2 volumes, - Contoured Common Volume (VCC), intersection of 2 volumes between them, - Additional Contoured Volume (VSC), total volume delineated with imaging minus the common volume between 2 imageries.

Thus, within the rGTV relapse volume, it's important to know whether VSC of 18F-DOPA PET-CT is significant compared to that of MRI and would thus allow better definition of the volumes to be irradiated.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Adult > 18 and < 75 years old.

- Status WHO ≤ 2.

- Histological diagnosis of WHO grade III or IV glioma, in local recurrence after radiochemotherapy (60Gy/30 sessions + concomitant TEMOZOLOMIDE), postoperatively or exclusively.

- Recurrence in the field of initial radiotherapy.

- Indication for stereotactic radiotherapy alone, validated in neuro-oncology CPR.

- Patient affiliated to a social security system.

- Patient able to give consent.

Exclusion Criteria:

- Contraindication to new radiotherapy.

- First treatment other than standard radiochemotherapy (60Gy/30 session + concomitant TEMOZOLOMIDE), postoperative or exclusive.

- Contraindication to MRI and/or gadolinium injection.

- Pregnancy, breastfeeding.

- Follow-up of the patient impossible.

- Persons deprived of liberty or under guardianship

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04766632
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Central Hospital, Nancy, France
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Antoine VERGER, MD, PhD
Principal Investigator Affiliation	CHRU de Nancy
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	High Grade Glioma

Additional Details

The use of contrast enhancement in enhancing -T1 MRI, due to the rupture of the blood-brain barrier may underestimate the volume to be irradiated. The natural course of these gliomas after first irradiation is a second relapse within 12 months with, in 40% of cases, relapses outside the initial radiation field. Amino acid PET-CT (Positon Emission Tomography with Computed Tomography) could be an interesting alternative to tumor delineation because its results, do not depend on the rupture of the blood-brain barrier. Several studies have used amino acid PET in the planning of radiotherapy treatment for high-grade gliomas, but without a well-conducted prospective study. In the recurrent high-grade glioma population, no studies have been performed with 18F-DOPA.( 6-fluoro-[18F]-L-dihydroxyphenylalanine) The question therefore relates to the interest of cerebral 18F-DOPA PET-CT to improve the delineation of the volumes to be re-irradiated, during the recurrence of high-grade gliomas, and on the optimal methodology for determining GTV- PET. To compare GTV-TEP and GTV-MRI volumes with each other, and the r-GTV, volume corresponding to the relapse objectified on the follow-up MRI, the analysis will be based on 3 parameters:

- DICE index, similarity index between 2 volumes, - Contoured Common Volume (VCC), intersection of 2 volumes between them, - Additional Contoured Volume (VSC), total volume delineated with imaging minus the common volume between 2 imageries.

Arms & Interventions

Arms

Experimental: one group

patients with high grade glioma

Interventions

Device: - Brain PET-CT of 18F-DOPA

PET-CT is a nuclear medicine exam with radiopharmaceutical injection of 18F-DOPA for the patient

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