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

Primary Purpose

Brain Metastases, Radiation Necrosis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
early 18F-FDOPA uptake
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Metastases focused on measuring silicon PET/CT, 18F-DOPA, short time examination, Brain Metastases, Radiation Necrosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU AmiensRecruiting

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 28, 2023
Last Updated
March 9, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT05762172
Brief Title
Dynamic F-DOPA PET for Differential Diagnosis Between Recurrence and Radionecrosis of Brain Metastasis
Acronym
DYNDOPATEP
Official Title
Interest of the Early Dynamic F-DOPA PET Examination for Differential Diagnosis Between Recurrence and Radionecrosis of Brain Metastasis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastases, Radiation Necrosis
Keywords
silicon PET/CT, 18F-DOPA, short time examination, Brain Metastases, Radiation Necrosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
early 18F-FDOPA uptake
Intervention 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.
Primary Outcome Measure Information:
Title
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.
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marc-Etienne Meyer, Pr
Phone
03 22 45 60 10
Email
Meyer.Marc-Etienne@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc-Etienne MEYER, MD,PhD
Phone
+33 3 22 45 59 64
Email
meyer.marc-etienne@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Alexandre COUTTE, MD
First Name & Middle Initial & Last Name & Degree
Etienne FESSART, MD
First Name & Middle Initial & Last Name & Degree
Mathieu BOONE, MD
First Name & Middle Initial & Last Name & Degree
Aurélie MOREIRA, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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