Detection of Metastatic Brain Tumours Using Dynamic Glucose Enhanced MRI After D-glucose Injection
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Integral tumour contrast generated by GBCA and glucose experiments will be assessed using Area Under Curve (AUC).
研究概览
简要总结
This project will compare two MRI contrast agents in metastatic brain tumours in humans. More specifically, the investigators will compare the tumour contrast obtained using glucose versus the current standard gadolinium-based contrast agent (GBCA, gadobutrol, trade name Gadovist, will be used).
First, participants will receive a glucose bolus injection followed by glucose enhanced MRI. Second, participants will receive a Gd-DTPA bolus injection followed by Gd-DTPA enhanced MRI. Both contrast studies will be performed during the same MRI study, which will be under one hour long.
详细描述
Purpose: To quantitatively compare glucose-enhanced MRI with the current standard GBCA enhanced MRI in participants with metastatic brain tumours prior to receiving radiotherapy from British Columbia Cancer Agency at Vancouver Cancer Centre.
Hypotheses: 1) Glucose enhanced MRI will highlight malignant metastatic brain tumours with comparable contrast to noise compared to GBCA and 2) Glucose enhancements in brain tumours will offer unique and complementary information, when compared to GBCA enhanced MRIs.
Justification: The current standard MRI contrast agent for metastatic brain tumours, GBCA, is limited by low specificity since GBCA accumulates in regions with disrupted blood brain barrier due to cancer as well as radiation necrosis and pseudo-progression after radiotherapy. It is important for radiation oncologists to reliably identify recurrent cancer, necrosis and post-treatment inflammation; and GBCA does not allow this. Therefore, a clinical need exists for an MRI technique that offers improved specificity for characterization of metastatic brain tumours before and after therapy. Glucose enhanced MRI represents a new technique that could offer improved specificity for detecting metastatic brain tumours.
Justification for number of participants included: The magnitude of signal enhancement is expected to vary between participants because 1) metastatic brain tumours exhibit a variety of enhancements patterns including ring, solid and nodular and 2) metastatic brain tumours will range in size. Therefore, 20 participants is considered sufficient to provide a reasonably accurate estimation of the expected mean tumour contrast as well as the expected variance in tumour contrast for future clinical trials. One additional healthy participant will be included in the study to perform a 'test-run' for the complicated MRI and infusion protocol.
Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or females
- •Between 18 and 65 years of age
- •Of all ethnic groups
- •BCCA participants with at least one contrast enhancing brain mass with a diameter ≥ 1 cm and consistent with metastatic carcinoma*
- •Able to give consent
- •Willingness to participate in the study * One additional healthy participant will be included in the study to perform a 'test-run' for the complicated MRI and infusion protocol.
排除标准
- •Pregnancy
- •Diabetes mellitus (self-reported or HbA1C ≥ 6.5%)
- •Ferromagnetic implant or foreign metallic bodies (pacemaker, loose metal, etc.)
- •Claustrophobia
- •History of kidney disease and/or eGFR < 60
- •Abnormal fasting blood glucose (<70mg/dL or >125 mg/dL)
- •Allergic to corn
- •History of adverse reactions to gadolinium based contrast agents
- •Poor performance status (Karnofsky PS<70%)
- •Previously received whole brain radiotherapy
- •All lesions evident on imaging were previously treated with stereotactic radiosurgery
- •The participants weigh more than 300lbs
- •The participants had surgery in the last 6 weeks
- •The participants have an intrauterine device
- •The participants have cosmetic tattoos
研究组 & 干预措施
dynamic glucose enhanced MRI after D-glucose injection
IV catheter preparation: Catheter will be placed in one arm. Fasting glucose levels measured with a glucometer using a 1-2 mL sample of blood. Only participants with normal fasting blood glucose levels (70-125 mg/dL) will proceed with the study. First IV catheter will monitor blood glucose every 10 min after bolus injection until it returns to normal. Second IV catheter is placed on the opposite arm for glucose infusion and GBCA (gadobutrol) infusion.
Glucose infusion protocol: Occurs when the participant is in the MRI. Bolus injection of hospital grade 25g of 50% dextrose solution over 1 min is to increase blood glucose concentrations to about 3-4 times the normal level. Blood glucose levels should return to normal levels within 30 to 60 min.
GBCA infusion protocol: Occurs when the participant is in the MRI; approximately 20 min after glucose infusion. Standard intravenous bolus injection of 0.1mM/kg of gadobutrol (Gadovist) at an injection rate of 5 mL/sec.
干预措施: Magnetic resonance imaging (Procedure)
dynamic glucose enhanced MRI after D-glucose injection
IV catheter preparation: Catheter will be placed in one arm. Fasting glucose levels measured with a glucometer using a 1-2 mL sample of blood. Only participants with normal fasting blood glucose levels (70-125 mg/dL) will proceed with the study. First IV catheter will monitor blood glucose every 10 min after bolus injection until it returns to normal. Second IV catheter is placed on the opposite arm for glucose infusion and GBCA (gadobutrol) infusion.
Glucose infusion protocol: Occurs when the participant is in the MRI. Bolus injection of hospital grade 25g of 50% dextrose solution over 1 min is to increase blood glucose concentrations to about 3-4 times the normal level. Blood glucose levels should return to normal levels within 30 to 60 min.
GBCA infusion protocol: Occurs when the participant is in the MRI; approximately 20 min after glucose infusion. Standard intravenous bolus injection of 0.1mM/kg of gadobutrol (Gadovist) at an injection rate of 5 mL/sec.
干预措施: Gadovist (Gadobutrol) (Drug)
dynamic glucose enhanced MRI after D-glucose injection
IV catheter preparation: Catheter will be placed in one arm. Fasting glucose levels measured with a glucometer using a 1-2 mL sample of blood. Only participants with normal fasting blood glucose levels (70-125 mg/dL) will proceed with the study. First IV catheter will monitor blood glucose every 10 min after bolus injection until it returns to normal. Second IV catheter is placed on the opposite arm for glucose infusion and GBCA (gadobutrol) infusion.
Glucose infusion protocol: Occurs when the participant is in the MRI. Bolus injection of hospital grade 25g of 50% dextrose solution over 1 min is to increase blood glucose concentrations to about 3-4 times the normal level. Blood glucose levels should return to normal levels within 30 to 60 min.
GBCA infusion protocol: Occurs when the participant is in the MRI; approximately 20 min after glucose infusion. Standard intravenous bolus injection of 0.1mM/kg of gadobutrol (Gadovist) at an injection rate of 5 mL/sec.
干预措施: 50% dextrose solution (Drug)
结局指标
主要结局
Integral tumour contrast generated by GBCA and glucose experiments will be assessed using Area Under Curve (AUC).
时间窗: 1h procedure
Area Under Curve (AUC) is measured using a sequence of MR images acquired before and after contrast injection. AUC values will be compared in tumour and contralateral brain areas to calculate the integral tumour contrast generated by glucose and GBCA experiments.
次要结局
- Maximum instantaneous tumour contrast generated by GBCA and glucose experiments will be assessed.(1h procedure)
研究者
Michael McKenzie
Radiation Oncologist
British Columbia Cancer Agency