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

NCT04097535 | Completed Results

• 2 other identifiers: 18HH4394228245
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioma

Keywords

PET/MRI; Fatty Acid Oxidation

Outcome Measures

Primary Outcomes (1)

• Quantitative Measurement of [18F]-FPIA Uptake in Human Gliomas

  Standardised uptake values (SUV) on \[18F\]FPIA PET/MRI

  -21-0 days

Secondary Outcomes (1)

• Correlation of 18F-FPIA Uptake With Tumour Type and Histological Grade Including O6-methylguanine-DNA Methyltransferase (MGMT) and Isocitrate Dehydrogenase (IDH) Gene Expression.

  0-3 months

Interventions

PET/MRI OTHER

Imaging scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with radiological evidence of suspected cerebral glioma due for surgery or biopsy

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College Healthcare NHS Trust/ Imperial College london

London, W12 0NN, United Kingdom

Location

Related Publications (1)

• Islam S, Inglese M, Grech-Sollars M, Aravind P, Dubash S, Barwick TD, O'Neill K, Wang J, Saleem A, O'Callaghan J, Anchini G, Williams M, Waldman A, Aboagye EO. Feasibility of [18F]fluoropivalate hybrid PET/MRI for imaging lower and higher grade glioma: a prospective first-in-patient pilot study. Eur J Nucl Med Mol Imaging. 2023 Nov;50(13):3982-3995. doi: 10.1007/s00259-023-06330-0. Epub 2023 Jul 25.

  PMID: 37490079 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Brain biopsy / surgical resection tissue

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Results Point of Contact

• Title: Professor Eric Aboagye
• Organization: Imperial College London

eric.aboagye@imperial.ac.uk

02083833759

Study Officials

• Matthew Williams, MBChB

  Imperial College Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 20, 2019
• Study Start: December 6, 2018
• Primary Completion: August 7, 2020
• Study Completion: August 7, 2020
• Last Updated: November 21, 2024
• Results First Posted: November 21, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)