A prospective pilot study to compare target volume delineation in meningiomas using 68Ga-DOTATATE PET/CT (positron emission tomography/ computed tomography) and current standard of care imaging (MRI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Differences in Gross tumor volume delineation of meningiomas by using 68Ga-DOTATATE PET/CT and gadolinium-enhanced standard MRI in comparison with each other.
研究概览
简要总结
Intracranial meningioma is one of the most common primary intracranial tumors. It constitutes 10%–15% of all brain neoplasm across the globe, whereas in India, their occurrence varies from 11.6% to 21%. The mainstay of therapy is surgical resection. Adjuvant radiation therapy can be offered for high grade, unresectable, incompletely resected, or recurrent disease. The usage of advanced techniques such as stereotactic radiosurgery and intensity modulated radiation therapy ensures a highly conformal dose to tumour and reduces the dose to surrounding healthy tissues at the same time. The efficacy of these techniques is dependent on accurate target delineation, currently defined by computed tomography (CT) and magnetic resonance imaging (MRI) with gadolinium, the standard for defining disease extent.
However, in infiltrative lesions and in the case of scar formation after surgery or radiation, studies have shown that contrast enhanced MRI imaging may be limited in terms of sensitivity and specificity of diagnosis due to, for example, unspecific contrast enhancement of scar tissue.
Majority of the meningiomas are known to express somatostatin receptor-2 (SSTR2), and with an excellent tumour-to-background ratio, imaging with somatostatin receptor ligands has been established as a method for detection and target volume definition of meningiomas before radiation therapy.
The somatostatin analog DOTATATE has shown high affinity for SSTR2. Labeled with the positron-emitting generator nuclide 68Ga, DOTATATE is increasingly being used for PET investigation of meningiomas, particularly for treatment planning.
This study aims to demonstrate the advantages and disadvantages of incorporating 68Ga- DOTATATE PET/CT for target volume delineation in meningiomas planned for radiation therapy.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Any meningioma with at least 10 mm measurable residual disease.
- •Meningioma patients planned for radiation therapy.
- •Ability to understand and the willingness to sign an IRB approved written informed consent document in accordance with regulatory and institutional guidelines before study entry.
- •For woman of childbearing potential who are intermediate or high risk, must be negative for pregnancy at time of beginning of radiation and should be willing to practice adequate contraception throughout the entire course of EBRT.
- •Resected WHO Grade 1 or 2 meningiomas with inadequate margins.
- •WHO Grade 3 meningiomas
- •Unresectable symptomatic meningiomas.
排除标准
- •Neurofibromatosis Type 1,2
- •Extracranial meningioma
- •Previous radiation therapy given to the scalp, cranium, brain, or skull base within the last 3 years
- •Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years.
- •Pregnancy
- •Inability to receive gadolinium, for e.g. allergy
- •Inability to undergo Ga 68- DOTAPET, for e.g. non co-operative.
- •Resected WHO Grade 1 or 2 meningiomas with adequate margins.
- •Asymptomatic unresectable meningiomas.
结局指标
主要结局
Differences in Gross tumor volume delineation of meningiomas by using 68Ga-DOTATATE PET/CT and gadolinium-enhanced standard MRI in comparison with each other.
时间窗: 2 years
次要结局
- Differences in planning target volume (PTV) contoured using 68Ga-DOTATATE PET/CT versus standard gadolinium enhanced MRI.(2 years)
- Comparing OAR (Organs at risk) doses between treatment volumes contoured using 68Ga- DOTATATE PET/CT with those contoured using MRI with gadolinium(2 years)
- Assessing the patterns of recurrence of meningiomas in patients who have received radiation(2 years)
研究者
Fraser Borgio
Christian Medical College, Vellore
