Dynamic F-DOPA PET for Differential Diagnosis Between Recurrence and Radionecrosis of Brain Metastasis

NCT05762172 | Completed

• 1 other identifier: PI2022_843_0055
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Contrast-enhanced magnetic resonance imaging is the most widely used examination for detecting the presence of brain metastasis. Functional sequences such as perfusion weighted imaging makes it possible to differentiate tumor recurrence from cerebral radionecrosis. However, this imaging technique may exhibit limitations, especially for brain lesions consisting of a mixture of necrotic tissue and tumor progression or depending on the location of the lesion in the brain. The use of 18F-DOPA PET is another option available to oncologists. Many studies on gliomas showed the superiority of this imaging technique over contrast-enhanced MRI. However, this imaging solution has been very poorly studied for brain metastases. The new PET technology equiped with silicon detectors makes it possible to obtain greater sensitivities than those of previous generations. It also make possible to obtain images in very short acquisition times. After injection, the hardware allows to obtain the perfusion kinetics of the lesion thanks to a very short temporal sampling (i.e. three seconds). The main objective of this pilot study is to evaluate the association between early activity measurements (\< 4 minutes post-injection) of 18F-FDOPA in PET and the differential diagnosis between radionecrosis and recurrence of cerebral metastases treated by radiotherapy.

Conditions

Brain Metastases; Radiation Necrosis

Keywords

silicon PET/CT; 18F-DOPA; short time examination; Brain Metastases; Radiation Necrosis

Outcome Measures

Primary Outcomes (1)

• difference between the maximum activity (in Bq/mL) in the venous sinus and the maximum activity present in the region of interest encompassing the lesion being studied.

  30 minutes

Interventions

early 18F-FDOPA uptake OTHER

During the usual patient care protocol for the 18F-FDOPA TEP examination, a 10 min acquisition starts after a 15 minutes waiting period following the injection of the radiotracer. This allows the reconstruction of a single late image volume. In the framework of this project, the patient is placed in the machine at the time of injection so as to acquire early 18F-FDOPA uptake and then reconstruct intermediate image volumes in addition to the usual final volume. The total duration of the patient's examination is therefore not changed.

Eligibility Criteria

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

You may qualify if:

• Patient referred for cerebral 18F-FDOPA 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 opposition

You may not qualify if:

• Age under 18
• Person under guardianship or curators
• Pregnant woman

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, Picardie, 80054, France

Location

Related Publications (1)

• Bailly P, Bouzerar R, Barrat I, Boone M, Coutte A, Meyer ME. A Practical, Short, [18F]F-DOPA PET/CT Acquisition Method for Distinguishing Recurrent Brain Metastases from Radionecrosis Following Radiotherapy. J Clin Med. 2025 Mar 22;14(7):2168. doi: 10.3390/jcm14072168.

  PMID: 40217619 RESULT

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 9, 2023
• Study Start: February 1, 2022
• Primary Completion: November 11, 2024
• Study Completion: November 11, 2024
• Last Updated: November 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)