18F-DOPA-PET in Non-tumoral and Tumoral Brain Lesions

Completed

• Conditions: Brain Tumor
• Interventions: Diagnostic Test: FDOPA-TEP

• Registration Number: NCT04306484
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

Background: 3,4-dihydroxy-6-\[18F\]-fluoro-L-phenylalanine (FDOPA) positron emission tomography (PET) can identify well low and high grade brain tumors. However, increased FDOPA uptake has been reported in non-tumoral brain lesions. The aim was to analyse FDOPA-PET in patients with non-tumoral brain lesions and to compare them with patients with (low and high grade) brain tumors.

Methods: retrospective analyse. Patients consecutively recruited with suspected primary brain tumor (based on clinical and MRI findings) referred for FDOPA-PET at Nimes university Hospital between June 2015 and June 2019. FDOPA-PET parameters (maximum and mean lesion standardized uptake values \[SUV\] and ratios comparing lesion with different background uptake SUV) and thresholds were analysed in search for those offering optimal discrimination between non-tumoral and tumoral lesions.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2020-02-29
• Study Completion: 2020-02-29
• Status Verified: 2020-03
• Study First Submitted: 2020-03-10
• Study First Submitted QC: 2020-03-10
• Last Update Submitted: 2020-03-12
• Study First Posted: 2020-03-13
• Last Update Posted: 2020-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• presence of defined tumor (histology was required) or non-tumor (diagnosed by histological or other analyses) diagnosis,
• clinical and MRI follow-up of >24 months,
• FDOPA-PET scan <2 months before surgery or stereotactic biopsy (when performed)

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with tumoral brain lesion	FDOPA-TEP	The 48 tumor patients included 8 low grade (grade II glioma, n=7; grade II ependymoma, n=1), and 40 high grade (grade III glioma, n=12; grade IV glioma, n=25, primary cerebral lymphoma, n=1; medulloblastoma, n=1, and metastatic cerebral breast cancer, n=1) tumors. Histology was available for all tumor patients.
patients with non-tumoral brain lesion	FDOPA-TEP	The non-tumor group included patients with an inflammatory lesion (n=11), lobar primary intracerebral haemorrhage (n=3), cortical dysplasia (n=3), infectious lesion (n=2, both toxoplasmosis), cerebral cavernomatous malformation (n=1), seronegative autoimmune limbic encephalitis (n=1), deep venous sinus thrombosis-related oedema (n=1), brain infarction (n=1), chronic posttraumatic brain lesion (n=1), radionecrosis after radiation therapy for arteriovenous malformation (n=1), and mixed inflammatory/infectious lesion (n=1, multiple sclerosis lesion complicated by biopsy-related infection).

Primary Outcome Measures

Name	Time	Method
FDOPA-TEP	Day 1	analyse of FDOPA-PET parameters (maximum and mean lesion standardized uptake values \[SUV\] and ratios comparing lesion with different background uptake SUV)

Trial Locations

Locations (1)

CHU de Nîmes; 🇫🇷 Nîmes, France