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

Alan Nichol

Status and phase: Completed; Phase 2

Conditions: Cancer (High-grace Glioma)

Treatments: Procedure: Surgical neuronavigation with 18F-DOPA PET imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT01248754

H10-02888

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

18F-DOPA PET imaging

Experimental group

Description:

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.

Treatment:

Procedure: Surgical neuronavigation with 18F-DOPA PET imaging