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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
High-grade Glioma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The proportion of subjects that have a complete resection of the volume of 18F-FDOPA PET tracer on their postoperative 18F-FDOPA PET scan.

Outcome Time Frame:

Less than 72 hours postoperatively

Safety Issue:

No

Principal Investigator

Alan Nichol, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

British Columbia Cancer Agency

Authority:

Canada: Health Canada

Study ID:

H10-02888

NCT ID:

NCT01248754

Start Date:

July 2011

Completion Date:

Related Keywords:

  • High-Grade Glioma
  • Neurosurgery
  • Neuronavigation
  • Positron emission tomography
  • FDOPA
  • Glioma

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