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

NCT04306484 | Completed

• 1 other identifier: LOCAL/2020/DR-01
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Tumor

Keywords

tumor; tumoral; non-tumoral; pseudotumoral; 3,4-dihydroxy-6-[18F]-fluoro-L-phenylalanine; FDOPA; positron emission tomography; PET

Outcome Measures

Primary Outcomes (1)

• FDOPA-TEP

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

  Day 1

Study Arms (2)

patients with tumoral brain lesion

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.

Diagnostic Test: FDOPA-TEP

patients with non-tumoral brain lesion

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).

Diagnostic Test: FDOPA-TEP

Interventions

FDOPA-TEP DIAGNOSTIC_TEST

FDOPA-TEP performed as part of the normal management of a suspected brain tumour

patients with non-tumoral brain lesion; patients with tumoral brain lesion

Eligibility Criteria

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

Study Population

patients with suspected primary brain tumor (based on clinical and MRI findings) referred for FDOPA-PET in our centre between June 2015 and June 2019

You may qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes

Nîmes, 30029, France

Location

Related Publications (1)

• Renard D, Collombier L, Laurent-Chabalier S, Mura T, Le Floch A, Fertit HE, Thouvenot E, Guillamo JS. 18F-FDOPA-PET in pseudotumoral brain lesions. J Neurol. 2021 Apr;268(4):1266-1275. doi: 10.1007/s00415-020-10269-9. Epub 2020 Oct 21.

  PMID: 33084938 RESULT

MeSH Terms

Conditions

Brain Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 13, 2020
• Study Start: January 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: December 4, 2025

Record last verified: 2020-03

Locations

FR (1)