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

Primary Purpose

High Grade Glioma

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Brain PET-CT of 18F-DOPA
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for High Grade Glioma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHRU NANCY Brabois, nuclear medicine departmentRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

one group

Arm Description

patients with high grade glioma

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
Percentage of additional volume contouring (VSC) from 18F-DOPA brain PET/CT versus brain MRI within the relapse volume after re-irradiation using the other two original delineation methods: (i) Method 2 (ii) Method 3
Determine the optimal method for GTV-PET delineation from brain 18F-FDOPA PET/CT with respect to its relationship to rGTV.
Concordance of the 3 different GTV-TEP and rGTV assessed by the DICE index. The DICE index is interpreted as a Kappa value: <0: High disagreement 0.21-0.40 : Low agreement 0.41-0.6 : Medium agreement 0.61-0.8 : Strong agreement 0.81-1 : Excellent agreement
Determine the relationships between the 3 GTV-PETs and the GTV-MRI or initial radiation volume.
Concordance of the 3 different GTV-PET and GTV-MRI assessed by the DICE index.

Full Information

First Posted
January 6, 2021
Last Updated
July 5, 2023
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT04766632
Brief Title
Contribution of Cerebral 18F-DOPA PET-CT Scan in High-grade Recurrent Gliomas
Acronym
DORA
Official Title
Contribution of Cerebral 18F-DOPA PET-CT Scan in High-grade Recurrent Gliomas : a Monocentric Pilot Impact Study on the Practices of Defining Target Volumes Before RAdiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2021 (Actual)
Primary Completion Date
December 15, 2024 (Anticipated)
Study Completion Date
March 12, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Grade Glioma

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
one group
Arm Type
Experimental
Arm Description
patients with high grade glioma
Intervention Type
Device
Intervention Name(s)
Brain PET-CT of 18F-DOPA
Intervention Description
PET-CT is a nuclear medicine exam with radiopharmaceutical injection of 18F-DOPA for the patient
Primary Outcome Measure Information:
Title
To determine the contribution of 18F-DOPA PET/CT in the prediction of the extension of recurrences of high-grade gliomas (method1)
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
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)
Description
Percentage of additional volume contouring (VSC) from 18F-DOPA brain PET/CT versus brain MRI within the relapse volume after re-irradiation using the other two original delineation methods: (i) Method 2 (ii) Method 3
Time Frame
1 year
Title
Determine the optimal method for GTV-PET delineation from brain 18F-FDOPA PET/CT with respect to its relationship to rGTV.
Description
Concordance of the 3 different GTV-TEP and rGTV assessed by the DICE index. The DICE index is interpreted as a Kappa value: <0: High disagreement 0.21-0.40 : Low agreement 0.41-0.6 : Medium agreement 0.61-0.8 : Strong agreement 0.81-1 : Excellent agreement
Time Frame
1 year
Title
Determine the relationships between the 3 GTV-PETs and the GTV-MRI or initial radiation volume.
Description
Concordance of the 3 different GTV-PET and GTV-MRI assessed by the DICE index.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antoine VERGER, MD,PhD
Phone
0383155567
Ext
+33
Email
a.verger@chru-nancy.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Véronique ROCH, MSc
Phone
0383154276
Ext
+33
Email
v.roch@chru-nancy.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoine VERGER, MD, PhD
Organizational Affiliation
CHRU de Nancy
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU NANCY Brabois, nuclear medicine department
City
Vandoeuvre les Nancy cedex
ZIP/Postal Code
54511
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine Mr VERGER, MD,PhD
Phone
383154276
Ext
+33
Email
a.verger@chru-nancy.fr
First Name & Middle Initial & Last Name & Degree
Véronique Mrs ROCH, MsC
Phone
383154276
Ext
+33
Email
v.roch@chru-nancy.fr

12. IPD Sharing Statement

Learn more about this trial

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

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