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Measuring Fatty Acid Oxidation in Gliomas Using 18F-FPIA PET/MRI

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ClinicalTrials.gov Identifier: NCT04097535
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Tracking Information
First Submitted Date September 17, 2019
First Posted Date September 20, 2019
Last Update Posted Date February 12, 2020
Actual Study Start Date December 6, 2018
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 19, 2019)
Quantitative measurement of 18F-FPIA uptake in human gliomas [ Time Frame: Through study completion, an average of 1 year ]
PET/MRI
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 19, 2019)
Correlation of 18F-FPIA uptake with tumour type and histological grade including O6-methylguanine-DNA methyltransferase (MGMT) and isocitrate dehydrogenase (IDH) gene expression. [ Time Frame: Through study completion, an average of 1 year ]
PET/MRI & IHC
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Measuring Fatty Acid Oxidation in Gliomas Using 18F-FPIA PET/MRI
Official Title Determining the Magnitude of Early Steps of Fatty Acid Oxidation in Glioma Using 18F-FPIA
Brief Summary

Glioma is the most common primary malignant brain tumour in adults and has an extremely poor prognosis. The aim of this study is to quantify the degree of early step fatty acid oxidation in gliomas as imaged by 18F-FPIA PET/MRI in 10 evaluable patients.

The Investigators hypothesise that FPIA uptake will be higher in high-grade gliomas compared to lower grade gliomas, in keeping with a higher propensity of high grade tumours to generate ATP and NADPH via fatty acid oxidation under bioenergetic stress.

Detailed Description

10 evaluable participants with suspected cerebral glioma on previous MRI who are due to undergo surgical resection or biopsy will be enrolled into the study. The patients invited to participate in the study will provide full consent, but will only undergo 18F-FPIA PET/MRI imaging once they have satisfied the inclusion and exclusion criteria. Once these have been satisfied, eligible participants will proceed to 18F-FPIA PET/MRI.

On the day of imaging the participants will undergo a blood test to measure plasma concentrations of carnitine. During the scan, a single dose of 18F-FPIA (maximum, 370 MBq) IV will be administered to the participant followed by a whole brain dynamic PET/MRI scan over 66 minutes. During the MRI sequences, the participant will receive an additional IV bolus of Gadolinium contrast medium administered through a peripheral venous cannula. Arterial blood sampling through a peripheral arterial line will be performed to determine the concentration of radiotracer within arterial plasma. All the participants that are enrolled into the study will undergo biopsy or surgical resection as part of their routine clinical care, from which their tumour grade will be confirmed; the Investigators will obtain tissue from these procedures to perform metabolomics, genomics and proteomics. Surgery or biopsy will be performed typically within 2 weeks but no later than 3 months.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Brain biopsy / surgical resection tissue
Sampling Method Non-Probability Sample
Study Population Patients with radiological evidence of suspected cerebral glioma due for surgery or biopsy
Condition Glioma
Intervention Other: PET/MRI
Imaging scan
Study Groups/Cohorts Not Provided
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 Recruiting
Estimated Enrollment
 (submitted: September 19, 2019)
10
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 1, 2020
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Patients with radiological evidence of suspected cerebral glioma due for surgery or biopsy and with the following characteristics will be recruited:

  • Age ≥18
  • Tumour size at least 2 cm.
  • WHO performance status 0 - 2.
  • If female, the subject is either post-menopausal (at least 1 year), or surgically sterilized (has had a documented bilateral oophorectomy and/or documented hysterectomy for at least 2 years,), or if of childbearing potential, must have a negative urine beta human chorionic gonadotropin pregnancy test done at initial screening and on the day of tracer administration. The result of the pregnancy test must be known before administration of 18F-FPIA injection.
  • The subject is able and willing to comply with study procedures, and signed and dated informed consent is obtained.
  • The subject has a satisfactory medical history as judged by the investigator with no significant co-morbidities, physical examination, and vital signs findings during the screening period (from 21 days before administration).
  • The subject's clinical and laboratory tests are within normal limits and/or considered clinically insignificant.

Exclusion

  • The subject has received any chemotherapy, immunotherapy, biologic therapy or investigational therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of 18F-FPIA injection. The subject is pregnant or lactating.
  • The subject is diabetic or has uncontrolled blood glucose or blood lipid levels (clinical decision by investigator), any other chronic illness that will preclude brief discontinuation of medication, or musculoskeletal condition that would not allow comfortable performance of a 66-minute study.
  • The subject has received another investigational radioactive tracer within 1 month before administration of 18F-FPIA injection.
  • Anticoagulation therapy, prolonged prothrombin time, abnormal Allen's test.
  • Unsatisfactory renal function (eGFR<60)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Shah Islam, MBBS FRCR 0203 313 1000 ext 33720 s.islam@imperial.ac.uk
Contact: CCIC 0203 313 1000 ext 33720 k.kozlowski@imperial.ac.uk
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT04097535
Other Study ID Numbers 18HH4394
228245 ( 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
Plan to Share IPD: No
Responsible Party Imperial College London
Study Sponsor Imperial College London
Collaborators Not Provided
Investigators
Principal Investigator: Matthew Williams, MBChB Imperial College Healthcare NHS Trust
PRS Account Imperial College London
Verification Date February 2020