Registering Genomics and Imaging of Tumors (ReGIT)

Обзор

This study is investigating how brain tumors might mutate over time, and whether new brain imaging tools like MRI and PET can predict these mutations.

Подробное описание

This study is investigating how brain tumors might mutate over time, and whether new brain imaging tools like MRI and PET can predict these mutations. Subjects who are radiologically diagnosed with gliomas and are expected to undergo a tumor biopsy will be enrolled in the study. Subjects will complete two visits and will then undergo a follow-up period. At the baseline visit, subjects will under go a pregnancy test (if applicable), two PET-CT scans using different radioactive tracers, an MRI scan, and blood draws. At the biopsy visit, the subject will undergo an MRI scan as part of their standard of care and at least biopsy samples will be collected for research purposes using stereotactic core biopsy. The study team will take pictures of the locations of tumor samples as they are removed during surgery. The samples then get studied for genetic mutations, and the study team will look at the parts of the image the samples came from to see if they could have been predicted. Follow-up MRIs and potentially other radiology scans will be completed as part of subjects' regular care on a schedule determined by their healthcare provider at the facility ordered by their physician. The study team will follow subjects' care and collect the information from their regularly scheduled treatments and brain scans after their biopsy.

Вмешательства

• Препарат FET F-18
  PET scan with FET prior to biopsy
• Препарат O-15 Radioisotope
  PET scan with O-15 Water prior to biopsy
• Процедура CT scan
  CT scan prior to biopsy
• Процедура MRI with gadolinium-based contrast
  MRI prior to biopsy
• Процедура Biopsy Collection
  Biopsy collection during standard of care neurosurgery for glioma diagnosis/excision

Первичные конечные точки

• Classification sensitivity [Срок оценки: Through study completion, an average of 1 year.]
• Multivariate analysis [Срок оценки: 2032]
• Survival [Срок оценки: 2032]

Критерии участия

Критерии включения

• Subject is between 18 and 89 years of age.
• Subject has radiologically-diagnosed or suspected WHO Grade II-IV glioma based on physician review or conformance with published WHO criteria as evaluated by the PI\*.
• Subject is treatment-naïve with the exception of previous biopsy for the above condition.
• Subject is planning to undergo surgical resection and biopsy of their brain tumor.
• Subject has sufficient tissue so that the study team is able to acquire at least 2 biopsy samples during resection.
• Subject is able to read and write in English.
• Subject is able to lay supine for up to 80 minutes.
• Subject is able to hold still during MRI procedures.
• Subject or their LAR has signed the consent form for participation in the study.

Критерии исключения

• Subject has conditions that would preclude the completion of an MRI such as claustrophobia, pacemaker, metal objects in the body, and/or pregnancy.
• Subject has serious unstable medical or mental illness.
• Subject has insufficient tissue to acquire at least two biopsy samples during resection.
• Subject has a medical contraindication to any element of the study procedures.
• Subject or their LAR has not read and signed the informed consent form, or does not understand its contents.
• Subject is pregnant.\*\*
• Subject is at high risk for NSF (eGFR<60 or serum creatine >1.3) and cannot follow the weight-based dosing protocol for Gadavist.\*\*\*

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Indiana University School of Medicine — Indianapolis

Идентификаторы

NCT: NCT05386043 · 11163

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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