Study on the Use of Radiomics in Gliomas of Initial DisgnosisRADDOPAGNCT04469244
Evaluation of the Use of Radiomics in 18F-FDOPA PET Examinations for the Characterization of Gliomas
An observational study of Study on the Use of Radiomics in Gliomas of Initial Disgnosis, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The evaluation of gliomas in imaging represents a real challenge today, at the initial diagnosis, for therapeutic planning or follow-up treatment of these lesions. There is an urgent need for non-invasive imaging tools to evaluate a glioma throughout its management. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Study on the Use of Radiomics in Gliomas of Initial Disgnosis
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2020to 20 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: common population that underwent a PET/CT scan at 18F-FDOPA for its glioma
Who may be able to join
- Patient having performed a PET/CT examination at 18F-FDOPA for his glioma in the nuclear medicine department of the CHRU de Brabois for which the raw data are available;
- Person who received full information on the organization of the research and did not object to the use of these data;
- Patients affiliated to a social security scheme
Who cannot join
- - Person who received full information on the organization of the research and who objected to the use of the data
- Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice).
- A person of full age who is unable to give consent and who is not subject to a legal protection measure.
Trial locations and contacts
1 site in 1 country.
About this study
The evaluation of gliomas in imaging represents a real challenge today, at the initial diagnosis, for therapeutic planning or follow-up treatment of these lesions. There is an urgent need for non-invasive imaging tools to evaluate a glioma throughout its management. At present, the diagnosis of certainty is only obtained through an anatomo-pathological analysis with sampling during an invasive procedure (surgery or biopsy). Magnetic resonance imaging, through perfusion, diffusion imaging or spectroscopy is developing in gliomas. However, it remains time-consuming and is not always available. At the same time, positron emission tomography (PET) with amino acids is an interesting alternative for these brain tumours. Amino acid PET has the advantage of being more specific than the abnormalities detected in MRI and the amino acid radiotracers cross the blood-brain barrier, even if not broken, unlike Gadolinium in MRI. Among these radiotracers, 18F-FDOPA can, among other things, assist in the non-invasive staging of gliomas at initial diagnosis.
- Keywords
- 18F-FDOPA, Glioma, Radiomics
- Medical subject headings
- Glioma
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance (sensitivity, specificity, accuracy) of parameters extracted from radiomic analysis to predict the molecular characteristics of gliomas at initial diagnosis.
Evaluating the performance of radiomics use in gliomas at initial diagnosis
Measured: 1 year
Secondary outcomes (4)
Diagnostic performance (sensitivity, specificity, accuracy) of parameters extracted from radiomic analysis to predict glioma recurrence
Assessing the performance of radiomics use in the search for glioma recurrence
Measured: 1 year
Diagnostic performance (sensitivity, specificity, accuracy) of parameters extracted from radiomic analysis to predict the response to glioma treatments.
Evaluating the performance of the use of radiomics in the follow-up of glioma disease treatments
Measured: 1 year
Comparison of dynamic parameters (time to peak, slope, area under curve) obtained with different reconstruction parameters versus dynamic parameters obtained on digital phantom from literature data
Optimization of dynamic analysis for the interpretation of the PET/CT examination at 18F-FDOPA
Measured: 6 months
Comparison of dynamic parameters (time to peak, slope, area under curve) obtained with different reconstruction parameters versus dynamic parameters obtained on digital phantom from literature data
Comparison of diagnostic performance of radiomics, static and dynamic parameters.
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start1 Jul 2020
- Primary completion3 Aug 2020
- Study completion20 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Study on the Use of Radiomics in Gliomas of Initial DisgnosisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antoine VERGER, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469244
- Sponsor's protocol ID
- 2020PI063
- Acronym
- RADDOPAG
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2020
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zaragori T, Oster J, Roch V, Hossu G, Chawki MB, Grignon R, Pouget C, Gauchotte G, Rech F, Blonski M, Taillandier L, Imbert L, Verger A. 18F-FDOPA PET for the Noninvasive Prediction of Glioma Molecular Parameters: A Radiomics Study. J Nucl Med. 2022 Jan;63(1):147-157. doi: 10.2967/jnumed.120.261545. Epub 2021 May 20.
PubMed 34016731
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Use of Radiomics in 18F-FDOPA PET Examinations for the Characterization of Gliomas
- ClinicalTrials.gov ID
- NCT04469244
- Acronym / sponsor ID
- RADDOPAG / 2020PI063
- Keywords
- 18F-FDOPA, Glioma, Radiomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 3 Aug 2020 (actual)
- Study completion
- 20 Oct 2020 (actual)
- First posted
- 14 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The evaluation of gliomas in imaging represents a real challenge today, at the initial diagnosis, for therapeutic planning or follow-up treatment of these lesions. There is an urgent need for non-invasive imaging tools to evaluate a glioma throughout its management. At present, the diagnosis of certainty is only obtained through an anatomo-pathological analysis with sampling during an invasive procedure (surgery or biopsy). Magnetic resonance imaging, through perfusion, diffusion imaging or spectroscopy is developing in gliomas. However, it remains time-consuming and is not always available. At the same time, positron emission tomography (PET) with amino acids is an interesting alternative for these brain tumours. Amino acid PET has the advantage of being more specific than the abnormalities detected in MRI and the amino acid radiotracers cross the blood-brain barrier, even if not broken, unlike Gadolinium in MRI. Among these radiotracers, 18F-FDOPA can, among other things, assist in the non-invasive staging of gliomas at initial diagnosis.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- common population that underwent a PET/CT scan at 18F-FDOPA for its glioma
Key inclusion criteria (3 listed)
- Patient having performed a PET/CT examination at 18F-FDOPA for his glioma in the nuclear medicine department of the CHRU de Brabois for which the raw data are available;
- Person who received full information on the organization of the research and did not object to the use of these data;
- Patients affiliated to a social security scheme
Key exclusion criteria (3 listed)
- - Person who received full information on the organization of the research and who objected to the use of the data
- Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice).
- A person of full age who is unable to give consent and who is not subject to a legal protection measure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic performance (sensitivity, specificity, accuracy) of parameters extracted from radiomic analysis to predict the molecular characteristics of gliomas at initial diagnosis.
Time frame: 1 year
Evaluating the performance of radiomics use in gliomas at initial diagnosis
4 secondary outcomes
Diagnostic performance (sensitivity, specificity, accuracy) of parameters extracted from radiomic analysis to predict glioma recurrence
Time frame: 1 year
Diagnostic performance (sensitivity, specificity, accuracy) of parameters extracted from radiomic analysis to predict the response to glioma treatments.
Time frame: 1 year
Comparison of dynamic parameters (time to peak, slope, area under curve) obtained with different reconstruction parameters versus dynamic parameters obtained on digital phantom from literature data
Time frame: 6 months
Comparison of dynamic parameters (time to peak, slope, area under curve) obtained with different reconstruction parameters versus dynamic parameters obtained on digital phantom from literature data
Time frame: 1 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Results publication: PubMed 34016731Zaragori T, Oster J, Roch V, Hossu G, Chawki MB, Grignon R, Pouget C, Gauchotte G, Rech F, Blonski M, Taillandier L, Imbert L, Verger A. 18F-FDOPA PET for the Noninvasive Prediction of Glioma Molecular Parameters: A Radiomics Study. J Nucl Med. 2022 Jan;63(1):147-157. doi: 10.2967/jnumed.120.261545. Epub 2021 May 20.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Study on the Use of Radiomics in Gliomas of Initial Disgnosis, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance (sensitivity, specificity, accuracy) of parameters extracted from radiomic analysis to predict the molecular characteristics of gliomas at initial diagnosis. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04469244, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.