Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT04097535
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Imperial College London

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.


Condition or disease Intervention/treatment
Glioma Other: PET/MRI

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determining the Magnitude of Early Steps of Fatty Acid Oxidation in Glioma Using 18F-FPIA
Actual Study Start Date : December 6, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: PET/MRI
    Imaging scan


Primary Outcome Measures :
  1. Quantitative measurement of 18F-FPIA uptake in human gliomas [ Time Frame: Through study completion, an average of 1 year ]
    PET/MRI


Secondary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
Brain biopsy / surgical resection tissue


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
Sampling Method:   Non-Probability Sample
Study Population
Patients with radiological evidence of suspected cerebral glioma due for surgery or biopsy
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)

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): NCT04097535


Contacts
Layout table for location 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

Locations
Layout table for location information
United Kingdom
Imperial College Healthcare NHS Trust/ Imperial College london Recruiting
London, United Kingdom, W12 0NN
Contact: Shah Islam, MBBS, FRCR    02033133720      
Contact: CCIC    02033133720    b.pratap@imperial.ac.uk   
Principal Investigator: Matthew Williams, MBChB         
Sub-Investigator: Shah Islam, MBBS FRCR         
Sponsors and Collaborators
Imperial College London
Investigators
Layout table for investigator information
Principal Investigator: Matthew Williams, MBChB Imperial College Healthcare NHS Trust

Layout table for additonal information
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT04097535     History of Changes
Other Study ID Numbers: 18HH4394
228245 ( Other Identifier: IRAS )
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
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
Keywords provided by Imperial College London:
PET/MRI
Fatty Acid Oxidation
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