We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04870580
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04870580
Recruitment Status : Recruiting
First Posted : May 3, 2021
Last Update Posted : July 29, 2022
Sponsor:
Collaborators:
Cancer Research UK
University of Oxford
Information provided by (Responsible Party):
University College, London

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Glioma Diagnostic Test: Fluorodopa PET tracer Not Applicable

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 confer different prognoses and management strategies. This distinction is normally made on biopsy sampling and conventional imaging. However, sampling errors are not uncommon due to the heterogeneous nature of glioma. Case series have described under-grading of gliomas on biopsy in 28% to 63% of cases. Furthermore, up to one third of high-grade gliomas may not display the typical imaging characteristics (enhancement) of a high-grade glioma. Therefore, more accurate imaging may help to make this distinction and guide biopsy and clinical management decisions at the outset.

There has been growing interest in the use of amino acid PET in glioma imaging. Transport of amino acids across the blood brain barrier and low physiological levels of tracer uptake within the brain allow for good tumour visualisation. The most frequently used amino acid PET tracers described in clinical literature are [11C]methionine, [18F]fluoroethyltyrosine and [18F]fluorodopa, which predominantly reflect leucine transport, being mainly transported by LAT1, a high affinity leucine transporter. Alongside depiction of tumour volume, described roles of amino acid PET include differentiation of true disease progression from pseudo progression, detection of residual disease in the post-surgical patient, biopsy guidance and prognostication.

Rationale The primary objective of the study will be to establish the feasibility of performing [18F]fluorodopa PET guided histopathology in a single and multi-site setting. Basic tumour characterisation (for example Ki67 expression and detection of IDH mutations) will be undertaken.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: [18F] FDOPA PET Imaging in Glioma: Feasibility Study for PET Guided Brain Biopsy
Actual Study Start Date : September 1, 2021
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : May 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Intervention arm
PET/CT with fluorodopa tracer
 Diagnostic Test: Fluorodopa PET tracer
PET/CT scan using fluorodopa tracer


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. To assess the feasibility of PET guided histopathology in a single and multi-site setting. [ Time Frame: 2 years ]
    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.


Secondary Outcome Measures :
  1. To investigate the inter-observer variation (IOV) in tumour to background uptake measurements to assess reliability. [ Time Frame: 2 years ]
    IOV in tumour to background uptake measurements

  2. To characterise dopamine uptake in high-grade glioma and low-grade glioma. [ Time Frame: 2 years ]
    SUV/TBR corresponding to the optimal cut-off value for high-grade and low-grade glioma on receiver operating characteristic curve analysis.

  3. To provide data on the proportion of high-grade transformation in low-grade glioma. [ Time Frame: 2 years ]
    Proportion of patients showing high-grade transformation following histopathology.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age over 18 years
  2. Diagnosed with low-grade glioma based on clinical standard of care imaging and scheduled for primary surgical resection of low-grade glioma
  3. 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.
  4. 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
  5. Willing and able to provide written informed consent

Exclusion Criteria:

  1. Females who are pregnant, planning pregnancy or breastfeeding
  2. 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.
  3. 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).
  4. 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.
  5. Neoadjuvant chemotherapy/radiotherapy treatment for low-grade glioma which would interfere with the interpretation of study results.
  6. Any other problems that may make the patient unable to tolerate the PET scans (e.g. claustrophobia).
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04870580


Contacts
Layout table for location contacts
Contact: JOY ROACH 01865 270000 joy.roach@oncology.ox.ac.uk
Contact: NCITA CTU ncita.fig@ucl.ac.uk

Locations
Layout table for location information
United Kingdom
Oxford University Hospitals NHS Foundation Trust Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Contact: Joy Roach, Dr    01865 270000    joy.roach@oncology.ox.ac.uk   
Contact: Edith Gallagher       edith.gallagher@oncology.ox.ac.uk   
Sponsors and Collaborators
University College, London
Cancer Research UK
University of Oxford
Investigators
Layout table for investigator information
Principal Investigator: Geoffrey Higgins University College, London
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT04870580    
Other Study ID Numbers: 127427
272494 ( Other Identifier: IRAS )
First Posted: May 3, 2021    Key Record Dates
Last Update Posted: July 29, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue