Status:
UNKNOWN
[18F] FDOPA PET Imaging in Glioma: Feasibility Study for PET Guided Brain Biopsy
Lead Sponsor:
University College, London
Collaborating Sponsors:
Cancer Research UK
University of Oxford
Conditions:
Glioma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
\[18F\]fluorodopa (3, 4-dihydroxy-6-\[18F\]fluoro-L-phenylalanine/ FDOPA) is an amino acid PET tracer originally developed for brain imaging in patients with movement disorders but has been found to b...
Detailed Description
Glioma is a cancer of unmet need, where survival trends have not significantly changed for decades. The distinction between high-grade (HGG) and low-grade glioma (LGG) is important as both entities co...
Eligibility Criteria
Inclusion
- Age over 18 years
- Diagnosed with low-grade glioma based on clinical standard of care imaging and scheduled for primary surgical resection of low-grade glioma
- Females of childbearing potential and males agree to use an effective method of contraception from the time consent is signed until 1 week after surgery.
- Females of childbearing potential have a negative urine pregnancy test within 7 days prior to being registered. Participants are considered not of child bearing potential if they are surgically sterile (i.e. they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal
- Willing and able to provide written informed consent
Exclusion
- Females who are pregnant, planning pregnancy or breastfeeding
- Concurrent and/or recent involvement in other research or use of another experimental investigational medicinal product that is likely to interfere with the study medication within 28 days of study enrolment.
- MRI contraindicated (e.g. implanted electric and electronic devices, heart pacemakers, insulin pumps, implanted hearing aids, neurostimulators, intracranial metal clips, metallic bodies in the eye).
- Other psychological, social or medical condition, physical examination finding or a laboratory abnormality that the Investigator considers would make the patient a poor study candidate or could interfere with protocol compliance or the interpretation of study results.
- Neoadjuvant chemotherapy/radiotherapy treatment for low-grade glioma which would interfere with the interpretation of study results.
- Any other problems that may make the patient unable to tolerate the PET scans (e.g. claustrophobia).
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2024
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04870580
Start Date
September 1 2021
End Date
May 1 2024
Last Update
November 18 2023
Active Locations (1)
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1
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, United Kingdom, OX3 9DU