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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04306484
Other study ID # LOCAL/2020/DR-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date February 29, 2020

Study information

Verified date March 2020
Source Centre Hospitalier Universitaire de Nimes
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 74
Est. completion date February 29, 2020
Est. primary completion date February 29, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France CHU de Nîmes Nîmes

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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