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

NCT04766632 | Completed

• 1 other identifier: A20200306
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

High Grade Glioma

Outcome Measures

Primary Outcomes (1)

• To determine the contribution of 18F-DOPA PET/CT in the prediction of the extension of recurrences of high-grade gliomas (method1)

  Percentage of additional volume contouring (VSC) from 18F-DOPA PET/CT versus MRI within the relapse volume after re-irradiation, using method 1 for GTV PET.

  1 year

Secondary Outcomes (3)

• To determine the contribution of 18F-DOPA PET/CT in the prediction of the extension of recurrences of high-grade gliomas with 2 other methods (method2 and 3)

  1 year

• Determine the optimal method for GTV-PET delineation from brain 18F-FDOPA PET/CT with respect to its relationship to rGTV.

  1 year

• Determine the relationships between the 3 GTV-PETs and the GTV-MRI or initial radiation volume.

  1 year

Study Arms (1)

one group

EXPERIMENTAL

patients with high grade glioma

Device: Brain PET-CT of 18F-DOPA

Interventions

Brain PET-CT of 18F-DOPA DEVICE

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

one group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU NANCY Brabois, nuclear medicine department

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Antoine VERGER, MD, PhD

  CHRU de Nancy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PMD, PhD

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: February 23, 2021
• Study Start: May 18, 2021
• Primary Completion: May 15, 2025
• Study Completion: June 3, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-06

Locations

FR (1)