A Pilot Study of 5-Aminolevulinic Acid (5-ALA) to Enhance Visualization of Pituitary Adenomas
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- Number of patients with intraoperative observed fluorescence of pituitary tumor
研究概览
简要总结
5-Aminolevulinic Acid (5-ALA) was approved by the FDA as an intraoperative optical imaging agent in patients with suspected high-grade gliomas (HGGs) in 2017. The investigators plan to administer 5-ALA to patients with pituitary tumors to demonstrate whether it can be used as an intraoperative optical imaging agent for this pathology. Overall, this pilot study will afford the overall opportunity to improve surgical management and advancement of the science of neurological and neuroendocrine disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with non-functioning pituitary adenomas who require surgical intervention, as deemed appropriate by a neurosurgeon, either due to size criteria, observed growth in lesion on MRI, and/or for alleviation of the symptoms of mass effect.
- •Patients with functional pituitary adenomas, including prolactinomas, growth-hormone secreting adenomas, and ACTH-secreting adenomas, where surgery is recommended for biochemical control. Patients with symptoms of Cushing's Disease and centralization of ACTH on IPSS without imaging-confirmed lesions will be included in the study.
排除标准
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to aminolevulinic acid (ALA). Patients should refrain from use of other potential phototoxic substances (e.g. tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts) for 72 hours.
- •Personal or family history of porphyria.
- •Uncontrolled concurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with 5-ALA breastfeeding should be discontinued if the mother is treated with 5-aminolevulinic acid.
- •Women who are pregnant or become pregnant will be excluded from the trial as it is unknown if aminolevulinic acid (ALA) is teratogenic or has abortifacient effects.
- •Prior history of GI perforation, diverticulitis, and/or peptic ulcer disease.
结局指标
主要结局
Number of patients with intraoperative observed fluorescence of pituitary tumor
时间窗: through study completion, an average of 3 months
Under blue light exposure of tumor, the investigators will document whether red fluorescence is seen (+ fluorescence) or not seen (- fluorescence). These will be categorized as a binary finding. If fluorescence is seen, the surgeon will biopsy this area to confirm that fluorescent tissue is consistent with pituitary adenoma by histopathology.
次要结局
- Differences in presence of fluorescence based on hormone receptor staining of the pituitary adenoma(through study completion, an average of 3 months)
研究者
Pamela Stuart Jones
Assistant Professor of Neurosurgery
Massachusetts General Hospital