NCT00188695已完成1 期
A Pilot Study of MR Imaging With Ultra-small Superparamagnetic Iron Oxide for Pelvic Lymph Node Target Definition
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Improved clinical target volume (CTV) definition for the purpose of adjuvant irradiation of pelvic lymph nodes using intensity modulated radiotherapy (IMRT).
研究概览
简要总结
The purpose of this study is to test whether or not a new contrast agent called Combidex, a contrast agent formulated from ultra-small superparamagnetic iron oxide (USPIO) improves the ability of Magnetic Resonance Imaging (MRI) to see lymph nodes in the pelvis. It might also help doctors tell whether or not cancer has spread to these lymph nodes. It might allow radiotherapy to be delivered more accurately.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •histologically confirmed endometrial, cervix, prostate (cT1-cT3) or bladder cancer
- •no distant metastases
- •informed consent
排除标准
- •confirmed prostate carcinoma and PSA less than or equal to 4 or greater than 100
- •radical surgery or prior cryosurgery for prostate carcinoma, previous RT, hormonal manipulation or chemotherapy
- •biopsy-proven lymph node involvement
- •endometrium or cervix carcinoma who have undergone recent pelvic surgery with the exclusion of D&C or biopsy
- •bladder carcinoma with recent pelvic surgery with the exclusion of TURBT
- •previous or concurrent cancers other than superficial basal or squamous cell skin carcinoma unless disease-free for at least 5 yrs
- •contraindication to MR imaging
- •hip prosthesis
- •major medical or psychiatric illness
- •patients with known allergy to dextran or iron-containing compounds
- •patients with cirrhosis or hemochromatosis
- •patients receiving another MR contrast within 2 hrs prior to the ferumoxtran-10
结局指标
主要结局
Improved clinical target volume (CTV) definition for the purpose of adjuvant irradiation of pelvic lymph nodes using intensity modulated radiotherapy (IMRT).
时间窗: once at time of imaging
Improved delineation of normal pelvic lymph nodes in patients with uterine, cervical, bladder and prostate cancers.
时间窗: once at time of imaging
次要结局
- Comparison of target lymph node delineation between nodal imaging with USPIO and volume expansion of vascular anatomy.(once at time of imaging)
- Demonstration of the pattern and distribution of pelvic nodal metastases in patients with uterine, cervical, bladder and prostate cancers.(once at time of imaging)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
A Study to Evaluate the Pharmacokinetics (How it Moves Into, Through and Out From the Body) of a New Gadolinium-based Contrast Agent (GBCA) After Injection and How Safe it is in Participants With Normal and Impaired Renal FunctionContrast Enhancement in Magnetic Resonance ImagingNCT05061979Bayer24
已完成
1 期
Efficacy of EVP 1001-1 (SeeMore) in the Assessment of Myocardial Viability in Patients With Cardiovascular DiseaseISCHEMIC CARDIOMYOPATHYNCT01989195Stanford University6
已完成
早期 1 期
Contrast-Enhanced Ultrasound Identification of Sentinel Nodes in Esophageal CancerEsophagusNCT03578224Sidney Kimmel Cancer Center at Thomas Jefferson University35
进行中（未招募）
4 期
Effectiveness of Contrast-Enhanced UltrasoundAbdominal InjuriesPhysical AbuseAccidental FallMotor Vehicle InjuryNCT03473249Children's Hospital of Philadelphia120
终止
1 期
Assessing Dynamic Magnetic Resonance (MR) Imaging in Patients With Recurrent High Grade Glioma Receiving ChemotherapyBrain NeoplasmsNCT00769093OHSU Knight Cancer Institute6