Assess Use of 18F-Fluciclovine for Patients With Large Brain Metastases Treated With Staged Stereotactic Radiosurgery

Официальное название

Characterization of Large Brain Metastases With 18F-Fluciclovine PET/CT Treated With Staged Stereotactic Radiosurgery

Обзор

The spread of cancer to the brain is referred to as brain metastases. Brain metastases are a common complication of cancer. This study is being done to determine whether the use of a new imaging agent, 18F-fluciclovine, is able to detect which patients are responding to radiation therapy. In addition, this study will look at the changes of the treated brain metastases using this imaging agent over time.

Вмешательства

• Препарат 18F fluciclovine
  Patients will receive a standard 5 millicuries dose of 18F-fluciclovine intravenously as a bolus injection. They will be required to fast for at least four hours prior to 18F-fluciclovine injection. Patients will be positioned for PET/CT brain imaging and will be injected with 18F-fluciclovine immediately prior to PET data acquisition. PET data will be collected in list mode up to 25 minutes post-injection. PET images will be reconstructed in two ways: as a standard static image of data acquired

Первичные конечные точки

• Change in sensitivity for PET/CT [Срок оценки: through study completion, an average of 1 year]
• Change in sensitivity for MRI [Срок оценки: through study completion, an average of 1 year]
• Change in the standardized uptake value (SUV) parameters [Срок оценки: through study completion, an average of 1 year]

Вторичные конечные точки (2)

• Compare change of SUV metrics of 18F-fluciclovine PET [Срок оценки: baseline]
• Compare change of SUV metrics of contrast-enhanced MRI [Срок оценки: baseline]

Критерии участия

Критерии включения

• Male or female, age ≥18 years
• Performance status, Eastern Cooperative Oncology Group 0-2
• Confirmed diagnosis of brain metastases with at least one untreated lesion >2 cm in maximum diameter
• Plan for SSRS per the treating team
• For women of childbearing potential, a negative serum pregnancy test within 14 days of registration is required
• For females of reproductive potential: use of highly effective contraception for at least 4 weeks prior to screening and agreement to use such a method during study participation and for an additional 1 week after post-treatment 18F-fluciclovine positron emission tomography/computerized tomography

Критерии исключения

• Prior anaphylactic reaction to 18F-fluciclovine
• Evidence of leptomeningeal disease
• Prior whole-brain radiation therapy
• Contraindication to MRI (e.g., due to safety reasons, such as presence of a pacemaker)
• Females pregnant at the expected time of 18F-fluciclovine administration
• Females who are expecting to be breastfeeding at the time of 18F-fluciclovine and unwilling to stop breast-feeding for 24 hours. Temporary cessation of breastfeeding 24 hours after the time of imaging is allowed
• Major medical illness or psychiatric/cognitive impairments, which in the investigator's opinion, will prevent completion of protocol therapy and/or preclude informed consent

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Miami Cancer Institute — Miami

Публикации

• Kotecha R, Aboian M, Nabavizadeh SA, Parent EE, Trifiletti DM, Chao ST. Letter regarding "Contribution of PET imaging to radiotherapy planning and monitoring in glioma patients-a report of the PET/RANO group": 18F-fluciclovine and target volume delineation. Neuro Oncol. 2021 Aug 2;23(8):1408-1409. doi: 10.1093/neuonc/noab097. No abstract available. PMID 34081125

Идентификаторы

NCT: NCT04689048 · 2019-KOT-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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