18F-Fluoride PET/CT Versus 99mTc-MDP Scanning for Detecting Bone Metastases: A Randomized, Multi-Center Trial to Compare Two Bone Imaging Techniques
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 550
- 试验地点
- 35
- 主要终点
- Analysis of the diagnostic performance of [18F]NaF fluoride PET/CT scanning
研究概览
简要总结
The primary objective is to compare the diagnostic performance of 18F- Fluoride PET/CT scanning to that of conventional bone scanning for detecting cancer that has spread to the bone (bone metastasis). The intent of the study is to determine whether 18F-Fluoride PET/CT will lead to improved treatment and patient outcomes.
详细描述
The trial will accrue four hundred-eighty eight (488) evaluable patients with breast cancer, prostate cancer or lung cancer (approximately 163 of each cancer type) referred for routine bone scanning by their respective physicians. The specific stages of cancer required for eligibility are described in the eligibility criteria.
Approximately eleven to fifteen qualified clinical centers will participate in the trial, with target enrollment for each site set at roughly 40-50 patients per site.
The images of the patients will be transmitted to ACR Image Metrix, an imaging contract research organization (iCRO), for quality assurance and archival. iCRO will conduct blinded core lab interpretations by 3 radiologists who have not been involved in the design of the trial nor the clinical image interpretation. The data from the core lab readings will be compared with the deliberations of a multidisciplinary panel of oncology experts who will be blinded to the initial scan results and will determine the standard of evidence (truth) for each patient. The analysis will be based on this comparison.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Patient is ≥ 18 years old at the time of the drug administration (Patient may be male or female of any race / ethnicity.)
- •Patient or patient's legally acceptable representative cognitively provides written informed consent
- •Patients without known bone metastases who are newly diagnosed with ≥ stage 3 breast cancer, ≥ stage 3 lung cancer, or ≥ stage 2 prostate cancer (and/or PSA >10 micrograms/L), including patient with recurrent breast, lung or prostate cancer
- •Patient is scheduled to undergo a conventional bone scan
- •Patient is capable of complying with study procedures
- •Patient is able to remain still for duration of imaging procedure (about one hour)
- •Patient may have had a prior PET or PET/CT scan for staging/restaging.
排除标准
- •Patient is < 18 years old at the time of the drug administration
- •Patient is pregnant or nursing;
- •testing on site at the institution (urine or serum ßHCG) within 24 hours prior to the start of investigational product administration
- •obtaining surgical history (e.g., tubal ligation or hysterectomy)
- •confirming the subject is post menopausal, with a minimum 1 year without menses
- •Patient has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data
- •Patient has known bone metastases
- •Patient has previously received [18F]NaF in the last thirty days
研究组 & 干预措施
F18-Fluoride PET/CT
Patients without known bone metastases who are newly diagnosed with ≥ stage 3 breast cancer, ≥ stage 3 lung cancer, or ≥ stage 2 prostate cancer (and/or PSA >10 micrograms/L), including patient with recurrent breast, lung or prostate cancer; Patient is scheduled to undergo a conventional bone scan
干预措施: Bone Scan: F18-Fluoride PET/CT or TC-MDP (Device)
TC-MDP Bone Scan
Patients without known bone metastases who are newly diagnosed with ≥ stage 3 breast cancer, ≥ stage 3 lung cancer, or ≥ stage 2 prostate cancer (and/or PSA >10 micrograms/L), including patient with recurrent breast, lung or prostate cancer; Patient is scheduled to undergo a conventional bone scan
干预措施: Bone Scan: F18-Fluoride PET/CT or TC-MDP (Device)
结局指标
主要结局
Analysis of the diagnostic performance of [18F]NaF fluoride PET/CT scanning
时间窗: 6 Months
The primary endpoint will be an analysis of the diagnostic performance of \[18F\]NaF fluoride PET/CT scanning to that of conventional bone scanning for detecting cancer that has spread to the bone (bone metastasis). The hypothesis is that PET/CT is superior to conventional bone scanning for detecting bone metastases. The primary metrics used for comparison will be the relative areas under the ROC curves generated by blinded core lab interpretations of the scans.
次要结局
未报告次要终点