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

NCT ID: NCT04306484

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

74 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2020-12-31

Brief Summary

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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

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Conditions

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Brain Tumor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

FDOPA-TEP

Intervention Type DIAGNOSTIC_TEST

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

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).

FDOPA-TEP

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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FDOPA-TEP

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Nîmes

Nîmes, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 33084938 (View on PubMed)

Other Identifiers

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LOCAL/2020/DR-01

Identifier Type: -

Identifier Source: org_study_id

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