mDesmo Cold kit for PET imaging to localize ACTH dependent Cushing syndrome.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- PET/CT imaging to provide functional as well as anatomical information for intra-operative tumor navigation and preservation of normal pituitary.
研究概览
简要总结
Cushing’ssyndrome (CS) is one of the most enigmatic endocrine disorders. It is importantto confirm the ACTH dependent hypercortisolism and distinguishing Cushing’sdisease from ectopic CS. Most of the ACTH dependent CS are caused by Cushing’sdisease, of which majority are due to microadenoma being less than 6 mm.Visualizingtumors within 10 mm pituitary and confirming its functional status ischallenging. Long-term remission/cure is determined bythe correct functional and anatomical delineation of corticotropinoma (pituitary-tumor).The treatment of choice in Cushing’s disease ispituitary microsurgery.However, pituitary-tumor is not well delineated withinthe sella in 30-40% using currently available investigations especially MRI andinferior petrosal sinus sampling, which affects intra-operative navigation forselective adenomectomy and influence remission rate.
Now we have developeda non-radioactive (cold kit) formulation. So that the same may be available toall hospital based radiopharmacy for quick and a facile synthesis of PET tracer,Ga-68 mDesmo, for lateralizing pituitary adenoma (Cushing’s disease) and differentialdiagnosis of ACTH-releasing pituitary adenoma (Cushing’s disease) from the ofectopic ACTH-secreting tumors by non-invasive molecular imaging (PET/CT).
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 5.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients diagnosed with endogenous Cushing’s syndrome 2.Patients in the age group of 5 to 75 years.
- •3.Patients willing to give consent.
排除标准
- •1.Patient with exogenous exposure to steroids 2.Ongoing pregnancy.
结局指标
主要结局
PET/CT imaging to provide functional as well as anatomical information for intra-operative tumor navigation and preservation of normal pituitary.
时间窗: Single time point.
次要结局
- Diagnostic outcome will benefit in precision surgery of pitutiary micro-adenoma(Single point)