"An Exploratory Study Regarding the Use of the Biomarker Dopamine Transporter (DAT) for Image Diagnosis of Clear Cell Renal Cell Carcinoma"
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Region Skane
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Number of Participants That Display Ioflupane-positivity in Tumors Detected Via CT-scan
研究概览
简要总结
The main objective is to study whether imaging detection of the biomarker DAT can be used to detect kidney tumors identified by computer tomography (CT), which are pathologically assesses as being of the clear cell subtype.
详细描述
Main objective of the trial:
The main objective is to investigate whether DaTSCAN with subsequent SPECT can detect elevated DAT levels in at least a lesion identified with CT in patients with clear cell renal cell carcinoma, as assesed by pathologist? DaTSCAN signal will be seen as positive, displaying intensity ≥3ggr higher than the background and correlating anatomically with at least one lesion found with CT. DaTSCAN is used routinely to detect the loss of dopaminergic neurons in the striatum of patients with clinically uncertain Parkinsonian Syndromes. The active substance in DaTSCAN, Ioflupane specifically binds to DAT. By analyzing the focal uptake of Ioflupane (123I) with SPECT / CT the progression of the disease may be clarified. In light of our findings that clear cell renal cancer express significantly elevated levels of DAT, we postulate that DaTSCAN can be used for detection of clear cell renal cell carcinoma.
Protection of trial subjects:
Very few adverse effects are reported for DatSCAN use. In this study we used the same dose and route of administration as is praxis for DaTSCAN when used for diagnostic investigation of Parkinsons disease. Albeit uncommon, pain at the injection site has been previously reported when the solution was injected into a small vain. To minimise the potential for pain at the injection site during administration in this study, a slow intravenous injection (not less than 15 to 20 seconds) via an arm vein was therefore applied. The injections were performed by routined staff at Skåne University Hospital, Department of Clinical Physiology / Nuclear Medicine in Malmö, where usual clinical preparedness for allergic reactions after injection was available.
Background therapy:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •suspected kidney cancer diagnosis
- •suspected spread of the cancer
- •patient is scheduled for surgery alternatively biopsy of kidney tumor
- •patient is 18 years or older
- •the patient has given their consent to participate in the study
- •female patients of reproductive age displays negative pregnancy test
排除标准
- •known or suspected allergy to Ioflupane or sodium acetate or acetic acid or ethanol
- •patient suffers from moderate to severe renal impairment and exhibits glomerular filtration rate (GFR) <40
- •patient is medicated for Parkinson's disease
- •patient is medicated with any of the following medications: amphetamine, benzatropine, buproprion, cocaine, mazindol, methylphenidate, phentermine, sertraline, levodopa, dexamphetamine, lisdexamphetamine, modafinil, moclobemid, venlafaxine
- •patient is pregnant
- •breastfeeding
- •patient suffers from mental inability unwillingness or language difficulties resulting in difficulty in understanding the meaning of taking part in the study
研究组 & 干预措施
experimental group
185 megabecquerel (MBq) of Ioflupane I-123 (DaTSCAN) will be administered IV to patients with suspected renal cell carcinoma, at a single occasion and followed by SPECT-analysis 5h after injection.The images from the DaTSCAN investigation will be analyzed and anatomically compared to CT-scan from the same the patient. Any adverse effects during the study will be reported.
This is a exploratory open single arm trial, including a small number of patients with suspected disseminated renal cell carcinoma.
干预措施: Ioflupane I123 (Drug)
结局指标
主要结局
Number of Participants That Display Ioflupane-positivity in Tumors Detected Via CT-scan
时间窗: Through study completion for each participant, an average of 3 months
The primary endpoint is to investigate if tumors detected with CT display Ioflupane positivity in patients with verified clear cell renal cell carcinoma (ccRCC). Ioflupane signal was considered positive when intensity was \>3 times background signal in anatomic position identified as a lesion by CT-scan
次要结局
- Number of Participants Diagnosed With Non-ccRCC That Display Ioflupane I123-negativity in Tumors Detected Via CT-scan(Through study completion for each participant, an average of 3 months)