[18F] FDOPA PET Imaging in Glioma: Feasibility Study for PET Guided Brain Biopsy

NCT04870580 | Unknown

• 2 other identifiers: 127427272494
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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 be useful in brain tumour imaging. \[18F\]fluorodopa has been demonstrated to be predominantly transported by the L-type amino acid transporter without significant uptake into surrounding normal brain parenchyma with the exception of the basal ganglia. Assessing the feasibility of performing PET guided histopathology in a single and multi-site setting will be crucial in order to use PET as a planning tool for brain biopsy to detect high-grade transformation in low-grade gliomas.

Conditions

Glioma

Outcome Measures

Primary Outcomes (1)

• To assess the feasibility of PET guided histopathology in a single and multi-site setting.

  Assessment of tumour standardised uptake values (SUV) from \[18F\]fluorodopa PET with matched histopathology data from biopsies for evaluable patients from a single site and multiple sites. The percentage of cases where it is possible to collect this data will inform the feasibility of performing the assessments in a single-site and multi-site setting with a 70% threshold used to determine feasibility.

  2 years

Secondary Outcomes (3)

• To investigate the inter-observer variation (IOV) in tumour to background uptake measurements to assess reliability.

  2 years

• To characterise dopamine uptake in high-grade glioma and low-grade glioma.

  2 years

• To provide data on the proportion of high-grade transformation in low-grade glioma.

  2 years

Study Arms (1)

Intervention arm

OTHER

PET/CT with fluorodopa tracer

Diagnostic Test: Fluorodopa PET tracer

Interventions

Fluorodopa PET tracer DIAGNOSTIC_TEST

PET/CT scan using fluorodopa tracer

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University College, London: lead
• Cancer Research UK: collaborator
• University of Oxford: collaborator

Study Sites (1)

Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Geoffrey Higgins

  University College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: May 3, 2021
• Study Start: September 1, 2021
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)