Status:
COMPLETED
Measuring Fatty Acid Oxidation in Gliomas Using 18F-FPIA PET/MRI
Lead Sponsor:
Imperial College London
Conditions:
Glioma
Eligibility:
All Genders
18+ years
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...
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...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
December 6 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 7 2020
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04097535
Start Date
December 6 2018
End Date
August 7 2020
Last Update
November 21 2024
Active Locations (1)
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1
Imperial College Healthcare NHS Trust/ Imperial College london
London, United Kingdom, W12 0NN