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

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

NCT ID: NCT05762172

Condition: Brain Metastases
Radiation Necrosis

Conditions: Official terms:
Neoplasm Metastasis
Brain Neoplasms
Recurrence
Necrosis

Conditions: Keywords:
silicon PET/CT
18F-DOPA
short time examination
Brain Metastases
Radiation Necrosis

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: early 18F-FDOPA uptake
Description: 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.

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 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 Exclusion Criteria: - Age under 18 - Person under guardianship or curators - Pregnant woman

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: CHU Amiens

Address:
City: Amiens
Zip: 80054
Country: France

Status: Recruiting

Contact:
Last name: Marc-Etienne MEYER, MD,PhD

Phone: +33 3 22 45 59 64
Email: meyer.marc-etienne@chu-amiens.fr

Investigator:
Last name: Alexandre COUTTE, MD
Email: Sub-Investigator

Investigator:
Last name: Etienne FESSART, MD
Email: Sub-Investigator

Investigator:
Last name: Mathieu BOONE, MD
Email: Sub-Investigator

Investigator:
Last name: Aurélie MOREIRA, MD
Email: Sub-Investigator

Start date: February 1, 2022

Completion date: August 2023

Lead sponsor:
Agency: Centre Hospitalier Universitaire, Amiens
Agency class: Other

Source: Centre Hospitalier Universitaire, Amiens

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05762172