Short Time ExaminationDYNFDGTEPNCT07632092
Early [18F]-FDG PET Dynamic Analysis in Brain Metastases After Radiotherapy.
An observational study of Short Time Examination and Brain Metastases, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Various treatment options are available for brain metastases, depending on factors such as lesion site or number lesions. Radiotherapy is a commonly used treatment. Following stereotactic radiotherapy for brain metastases, a potential complication, namely brain radionecrosis, can occur subsequently. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Short Time Examination, Brain Metastases, Radiation Necrosis
- What is being tested?
- CT scan
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 18 May 2026to 18 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient for whom a [18F]-FDG PET cerebral examination has been prescribed as part of the usual management of brain metastases will be eligible to the protocol
Who may be able to join
- Patient referred for cerebral [18F]-FDG PET examination prescribed as part of his usual medical care for brain metastasis.
- Age ≥ 18 years old
- Affiliation to a social security program
- Ability of the subject to understand and express his consent
Who cannot join
- Age under 18 years old
- Person under guardianship or curatorship
- Pregnant or breastfeeding woman
- Primary brain tumors
- Brain metastases from renal, thyroid or other cancers known to have low avidity for [18F]-FDG
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHRU Amiens
Amiens
Antoine GIRARD, MD, 33+3 22 45 03 81, Girard.Antoine@chu-amiens.fr
Alexandre COUTTE, MD
About this study
Official title: Interest of Early Dynamic Analysis of [18F]-FDG PET Images in the Differential Diagnosis Between Recurrence and Radionecrosis in Brain Metastases.
Various treatment options are available for brain metastases, depending on factors such as lesion site or number lesions. Radiotherapy is a commonly used treatment. Following stereotactic radiotherapy for brain metastases, a potential complication, namely brain radionecrosis, can occur subsequently. It is essential to differentiate between this radionecrosis and lesion recurrence in order to determine the appropriate treatment approach. Contrast-enhanced magnetic resonance imaging (MRI) is the most widely used technique for monitoring brain metastases. Therefore, patients undergo routine MRI at 3 months and during subsequent follow-ups, but if the lesion evolve and if distinguishing between recurrence and radionecrosis is challenging, an [18F]-FDG PET scan is then prescribed by oncologists or radiotherapists during follow-up consultations. As part of the standard patient management protocol, a 10-minute image acquisition begins after a 45-60 minutes wait following the radiotracer injection. A second image acquisition is then conducted 3-4 hours later. For both acquisitions, a low-dose X-ray scanner is synchronously coupled to allow attenuation correction of the PET images.
Patient for whom a [18F]-FDG PET cerebral examination has been prescribed as part of the usual management of brain metastases will be eligible to the protocol. If the patient agrees to participate, an early imaging session is initiated immediately upon radiotracer injection, lasting 15 minutes in addition to the standard acquisition protocol.
- Conditions
- Short Time Examination, Brain Metastases, Radiation Necrosis
- Being tested
- CT scan
- Keywords
- 18F]-FDG PET, Short Time Examination, Brain Metastases, Radiation Necrosis
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scanOther
The patient is installed in the PET camera as soon as he is injected, so that early fixation of the [18F]-FDG radiotracer can be recorded for 15 minutes. As part of this acquisition, a CT scan dedicated for attenuation correction is also performed. Both this scan and the late scan will be carried out at ultra--low dose so that the total dose received by the patient does not exceed what he would have received without this research. The patient's total examination time remains unchanged
What is being measured
The primary outcome is the main question the study is designed to answer.
ratio between lesion maximum activity and controlateral healthy tissue activity
Value of the measurement of the ratio of the maximum activity within the lesion to the average activity within the region of interest of the contralateral healthy tissue.
Measured: day1
Secondary outcomes (1)
association between kinetic uptake parameters and diagnosis
association between kinetic uptake parameters from compartmental models and the differential diagnosis of radionecrosis and recurrence of brain metastases treated by radiotherapy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start18 May 2026
- Primary completion18 Nov 2028 (estimated)
- Study completion18 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short Time ExaminationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07632092
- Sponsor's protocol ID
- PI2026_843_0020
- Acronym
- DYNFDGTEP
- Status last verified
- May 2026
- First submitted
- 2 Jun 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Early Dynamic Analysis of [18F]-FDG PET Images in the Differential Diagnosis Between Recurrence and Radionecrosis in Brain Metastases.
- ClinicalTrials.gov ID
- NCT07632092
- Acronym / sponsor ID
- DYNFDGTEP / PI2026_843_0020
- Conditions
- Short Time Examination, Brain Metastases, Radiation Necrosis
- Keywords
- 18F]-FDG PET, Short Time Examination, Brain Metastases, Radiation Necrosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 18 May 2026 (actual)
- Primary completion
- 18 Nov 2028 (estimated)
- Study completion
- 18 Nov 2028 (estimated)
- First posted
- 8 Jun 2026 (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.
Various treatment options are available for brain metastases, depending on factors such as lesion site or number lesions. Radiotherapy is a commonly used treatment. Following stereotactic radiotherapy for brain metastases, a potential complication, namely brain radionecrosis, can occur subsequently. It is essential to differentiate between this radionecrosis and lesion recurrence in order to determine the appropriate treatment approach. Contrast-enhanced magnetic resonance imaging (MRI) is the most widely used technique for monitoring brain metastases. Therefore, patients undergo routine MRI at 3 months and during subsequent follow-ups, but if the lesion evolve and if distinguishing between recurrence and radionecrosis is challenging, an [18F]-FDG PET scan is then prescribed by oncologists or radiotherapists during follow-up consultations. As part of the standard patient management protocol, a 10-minute image acquisition begins after a 45-60 minutes wait following the radiotracer injection. A second image acquisition is then conducted 3-4 hours later. For both acquisitions, a low-dose X-ray scanner is synchronously coupled to allow attenuation correction of the PET images.
Patient for whom a [18F]-FDG PET cerebral examination has been prescribed as part of the usual management of brain metastases will be eligible to the protocol. If the patient agrees to participate, an early imaging session is initiated immediately upon radiotracer injection, lasting 15 minutes in addition to the standard acquisition protocol.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient for whom a [18F]-FDG PET cerebral examination has been prescribed as part of the usual management of brain metastases will be eligible to the protocol
Key inclusion criteria (4 listed)
- Patient referred for cerebral [18F]-FDG PET examination prescribed as part of his usual medical care for brain metastasis.
- Age ≥ 18 years old
- Affiliation to a social security program
- Ability of the subject to understand and express his consent
Key exclusion criteria (5 listed)
- Age under 18 years old
- Person under guardianship or curatorship
- Pregnant or breastfeeding woman
- Primary brain tumors
- Brain metastases from renal, thyroid or other cancers known to have low avidity for [18F]-FDG
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT scanThe patient is installed in the PET camera as soon as he is injected, so that early fixation of the [18F]-FDG radiotracer can be recorded for 15 minutes. As part of this acquisition, a CT scan dedicated for attenuation correction is also performed. Both this scan and the late scan will be carried out at ultra--low dose so that the total dose received by the patient does not exceed what he would have received without this research. The patient's total examination time remains unchanged | Other | – |
Primary outcome
ratio between lesion maximum activity and controlateral healthy tissue activity
Time frame: day1
Value of the measurement of the ratio of the maximum activity within the lesion to the average activity within the region of interest of the contralateral healthy tissue.
1 secondary outcome
association between kinetic uptake parameters and diagnosis
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No
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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.
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 Short Time Examination and Brain Metastases, run by Centre Hospitalier Universitaire, Amiens 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 8 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antoine GIRARD (33+3 22 45 03 81, Girard.Antoine@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ratio between lesion maximum activity and controlateral healthy tissue activity (time frame: day1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2026.