Positron Emission Tomography (PET) With 3,4-dihydroxy-6-18F-fluoro-L-enylalanine (18F-FDOPA) Study

A Phase II Study Using 18F-FDOPA Positron Emission Tomography Imaging for Neurosurgery and Assessment of Surgical Resection

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01248754

Enrollment

Registered

2010-11-25

Start date

2011-07-31

Completion date

2014-01-31

Last updated

2016-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer (High-grace Glioma)

Keywords

Neurosurgery, Neuronavigation, Positron emission tomography, FDOPA

Brief summary

The 18F-FDOPA PET tracer is an amino acid analogue that can be used to visualize high-grade glioma not clearly identified on diagnostic MRI. Use of 18F-FDOPA PET will permit neurosurgeons to achieve a complete resection more frequently.

Interventions

PROCEDURESurgical neuronavigation with 18F-DOPA PET imaging

Subjects will undergo preoperative 18F-FDOPA PET imaging, which will be used in neuronavigation software to guide resection of their high-grade glioma. Postoperative 18F-FDOPA PET imaging will be obtained to determine the extent of resection.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Contrast-enhancing mass on diagnostic brain CT or MRI strongly suggesting a diagnosis of WHO grade III or IV glioma * Karnofsky Performance status (KPS) ≥ 70 * Age ≥18 years * Subject is able to understand and consent to study * Glomerular filtration rate (GFR) ≥ 45 ml/minute

Exclusion criteria

* Indication for urgent craniotomy to relieve mass effect * Only stereotactic biopsy indicated because tumour is located in eloquent brain. * The enhancement on the T1 MRI sequence involves or abuts the basal ganglia * Previous intracranial malignancy or any invasive malignancy unless free of disease \> 5 years * Prior cranial irradiation * Contra-indications to systemic radiation exposure: pregnancy or breast feeding * Subject exceeds the weight limit of the PET scanner bed (204.5 kg) * Subjects taking medication such as Levodopa for the treatment of Parkinson's Disease * Allergies or other contraindication to CT contrast or MRI contrast

Design outcomes

Primary

Measure	Time frame
The proportion of subjects that have a complete resection of the volume of 18F-FDOPA PET tracer on their postoperative 18F-FDOPA PET scan.	Less than 72 hours postoperatively

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026