Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-24 @ 2:52 PM
NCT ID:
NCT05801159
Eligibility Criteria:
Inclusion Criteria: Patients with histologically confirmed GBM following surgical resection of their tumour and are eligible for adjuvant chemoradiation with the following characteristics will be recruited:
* Age ≥18
* World Health Organisation (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 (beta-HCG) 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 Criteria:
* 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.
* Any other chronic illness that will or musculoskeletal condition that would not allow comfortable performance of a static PET study.
* The subject has received another investigational radioactive tracer within 1 month before administration of 18F-FPIA injection.
* Unsatisfactory renal function (epidermal growth factor receptor, eGFR\<60) within 3 months of \[18F\]FPIA injection.
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05801159
Study Brief:
Protocol Section:
NCT05801159