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

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ClinicalTrials.gov Identifier: NCT04870580
Recruitment Status : Not yet recruiting
First Posted : May 3, 2021
Last Update Posted : July 13, 2021
Sponsor:
Collaborators:
Cancer Research UK
University of Oxford
Information provided by (Responsible Party):
University College, London

Tracking Information
First Submitted Date  ICMJE April 12, 2021
First Posted Date  ICMJE May 3, 2021
Last Update Posted Date July 13, 2021
Estimated Study Start Date  ICMJE September 1, 2021
Estimated Primary Completion Date May 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2021)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2021)
  • 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
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE [18F] FDOPA PET Imaging in Glioma: Feasibility Study for PET Guided Brain Biopsy
Official Title  ICMJE [18F] FDOPA PET Imaging in Glioma: Feasibility Study for PET Guided Brain Biopsy
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Glioma
Intervention  ICMJE Diagnostic Test: Fluorodopa PET tracer
PET/CT scan using fluorodopa tracer
Study Arms  ICMJE Intervention arm
PET/CT with fluorodopa tracer
Intervention: Diagnostic Test: Fluorodopa PET tracer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 30, 2021)
21
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2023
Estimated Primary Completion Date May 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: JOY ROACH 01865 270000 joy.roach@oncology.ox.ac.uk
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04870580
Other Study ID Numbers  ICMJE 127427
272494 ( Other Identifier: IRAS )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University College, London
Study Sponsor  ICMJE University College, London
Collaborators  ICMJE
  • Cancer Research UK
  • University of Oxford
Investigators  ICMJE
Principal Investigator: Geoffrey Higgins University College, London
PRS Account University College, London
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP