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

June 4, 2025 updated by: Antoine VERGER, Central Hospital, Nancy, France

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

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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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Vandoeuvre les Nancy cedex, France, 54511
        • CHRU NANCY Brabois, nuclear medicine department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: one group
patients with high grade glioma
Device: Brain PET-CT of 18F-DOPA
PET-CT is a nuclear medicine exam with radiopharmaceutical injection of 18F-DOPA for the patient

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To determine the contribution of 18F-DOPA PET/CT in the prediction of the extension of recurrences of high-grade gliomas (method1)
Time Frame: 1 year
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Time Frame: 1 year

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
1 year
Determine the optimal method for GTV-PET delineation from brain 18F-FDOPA PET/CT with respect to its relationship to rGTV.
Time Frame: 1 year

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
1 year
Determine the relationships between the 3 GTV-PETs and the GTV-MRI or initial radiation volume.
Time Frame: 1 year
Concordance of the 3 different GTV-PET and GTV-MRI assessed by the DICE index.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Central Hospital, Nancy, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Antoine VERGER, MD, PhD, CHRU de Nancy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 18, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 3, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A20200306

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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