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

NCT ID: NCT01248754

Last Updated: 2016-10-20

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

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2014-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer (High-grace Glioma)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Surgical neuronavigation with 18F-DOPA PET imaging

Intervention Type PROCEDURE

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.

Interventions

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Surgical 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alan Nichol

OTHER

Sponsor Role lead

Responsible Party

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Alan Nichol

Radiation Oncologist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Alan Nichol, MD

Role: PRINCIPAL_INVESTIGATOR

British Columbia Cancer Agency

Locations

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Lions Gate Hospital

North Vancouver, British Columbia, Canada

Site Status

Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status

BC Cancer Agency

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Related Links

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http://www.surgery.ubc.ca/

UBC Department of Surgery

Other Identifiers

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H10-02888

Identifier Type: -

Identifier Source: org_study_id

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