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临床试验/NCT03264456
NCT03264456已完成1 期

Pretreatment Staging of High-Risk Prostate Cancer With 18F-Fluciclovine PET/MRI

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2017年11月8日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
18
试验地点
1
主要终点
Number of Patients With Primary Lesions Detected

研究概览

简要总结

There is great need for improved preoperative imaging in men with high-risk prostate cancer. Investigators propose to develop and validate an optimized simultaneous PET/MRI protocol for local, regional and whole body preoperative staging in a single imaging session using the amino acid PET tracer, F-18 fluciclovine. Despite advances in the diagnosis and treatment of prostate cancer, the preoperative staging of men with prostate carcinoma (PCa) is currently problematic. Conventional imaging is falsely negative for regional lymph node metastases in a substantial fraction of men. In particular, approximately 35% of men with high-risk prostate cancer will have biochemical recurrence even after optimal surgical resection. A major benefit of simultaneous acquisition of a multiparametric prostate MRI (mpMRI) and F-18 fluciclovine PET includes having the patient undergo a single imaging study which provides both anatomic and molecular characterization of the tumor, including metastases which would potentially be missed by conventional anatomic imaging and size criteria. Additionally, simultaneous acquisition will improve co-registration of the PET and MR data which is valuable for small lesions and in anatomically complex regions. Although the use of fluciclovine in the characterization of the primary PCa remains to be established, the anatomic detail provided by conventional mpMRI will complement the detection of small volume metastatic disease by fluciclovine PET. Additionally, the use of hybrid PET/MRI technology allows for the assessment of dynamic tracer uptake and washout during the whole body and regional PET/MRI scan, which may demonstrate the ability to increase detection of the primary PCa on fluciclovine PET. If F-18 fluciclovine PET/MRI can reliably and accurately detect nodal metastases in high-risk prostate cancer patients, surgeons may use this new technology to develop new treatment algorithms for the optimal management of these patients.

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
Male
接受健康志愿者

入选标准

  • High-risk biopsy-proven treatment-naïve prostate adenocarcinoma (Gleason score ≥ 8 and/or serum PSA > 20)

排除标准

  • Inability to tolerate or undergo PET/MRI
  • Previous or current hematologic or lymphatic disorder (including leukemia, lymphoma, Castleman's disease, etc.)
  • Recurrent prostate adenocarcinoma
  • Known visceral, osseous, or extrapelvic metastases prior to fluciclovine-PET/MRI
  • Known allergy to glucagon or gadolinium-based contrast

研究组 & 干预措施

[18F] Fluciclovine PET/MRI

Experimental

[18F] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer

干预措施: [18F] Fluciclovine PET/MRI (Diagnostic Test)

[18F] Fluciclovine PET/MRI

Experimental

[18F] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer

干预措施: [18F] fluciclovine (Drug)

结局指标

主要结局

Number of Patients With Primary Lesions Detected

时间窗: Baseline through 24 hr

Number of patients with primary lesions detected on 18-F fluciclovine PET/MRI

Number of Patients With Nodal Metastases Detected on Fluciclovine-PET/MRI

时间窗: Baseline through 24 hours

Number of patients with nodal metastases detected on \[18F\]fluciclovine PET/MRI

次要结局

  • Follow-up(Baseline through 8 weeks)
  • Number of Patients With Nodal Metastases Detected on PET/MRI vs. MRI(Baseline through 24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Samuel Joseph Galgano

Principal Investigator

University of Alabama at Birmingham

研究点 (1)

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