A Pilot Study Investigating ¹⁸F-FLT-PET as a Marker of Response to Preoperative Radiotherapy in Soft Tissue Sarcoma
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 主要终点
- Change in Fluorothymidine F-18 mean standardized uptake value (SUV) as response to therapy.
研究概览
简要总结
This pilot early phase I trial studies how well fluorothymidine F-18 positron emission tomography (PET) works in imaging patients with intermediate or high grade soft tissue sarcoma. Fluorothymidine F-18 PET may provide useful information about the tumor's response to treatment and may give the doctors early results that would better help to plan the post-surgical therapy.
详细描述
PRIMARY OBJECTIVES:
I. To determine fluorothymidine F-18 (¹⁸F-FLT) uptake parameters before and after radiotherapy.
SECONDARY OBJECTIVES:
I. To correlate ¹⁸F-FLT uptake post-radiotherapy scan with pathologic response. II. To correlate levels the mitotic index in surgical specimens with the ¹⁸F-FLT uptake in post-radiation scans.
III. To correlate ¹⁸F-FLT uptake both pre- and post-radiotherapy with magnetic resonance imaging (MRI) enhancement both within and around the tumor.
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
- •Participants must have histological evidence of an intermediate or high grade soft tissue sarcoma (STS) of any stage
- •Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as >= 1 cm with CT scan or MRI
- •Prior resection is allowed if there is measurable gross disease and the subject plans to have neoadjuvant radiotherapy followed by resection
- •Eastern Cooperative Oncology Group (ECOG) performance status =< 4, Karnofsky performance status >= 40%
- •Creatinine =< 3 x upper limit of normal (ULM)
- •Blood urea nitrogen (BUN) =< 3 x ULN
- •Participants should be willing and able to have both PET-CT scans
- •Participants should be eligible for and plan to undergo neoadjuvant radiation therapy and should be seen by a radiation oncologist prior to beginning the study; radiation at an outside facility will be allowed
- •Participants should be eligible for and plan to have resection with a surgeon specializing in STS at Oregon Health and Science University (OHSU) and should be seen by said surgeon prior to beginning the study
- •Participants should have a life expectancy that is greater than the study duration
- •Participants should be willing to use adequate contraception from the time of the first PET-CT scan to 2 months after radiotherapy finishes; should a woman become pregnant while participating in this study, she should inform her treating physician immediately
- •Women with childbearing potential must have a negative pregnancy test before each PET-CT scan
- •Participants should have the ability to understand and the willingness to sign a written informed consent document
- •Participants must sign a study specific consent form prior to registration
排除标准
- •Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or significant inflammation at treatment site or psychiatric illness/social situations that would limit compliance with study requirements or whose lab values do not meet the criteria above are excluded
- •Pregnant women are excluded from this study
- •Breast feeding women are excluded from this study
- •Patients receiving chemotherapy during the course of radiation are excluded
- •Patients whose weights exceed the tolerance of the table are excluded; the weight limit at OHSU is 450 pounds (lbs)
研究组 & 干预措施
Diagnostic (fluorothymidine F-18 PET)
Patients receive fluorothymidine F-18 IV over 1 minute and undergo PET scan over 60 minutes 21 or less days prior to standard of care radiation therapy and 14 or less days prior to the standard of care surgery.
干预措施: Fluorothymidine F-18 (Drug)
Diagnostic (fluorothymidine F-18 PET)
Patients receive fluorothymidine F-18 IV over 1 minute and undergo PET scan over 60 minutes 21 or less days prior to standard of care radiation therapy and 14 or less days prior to the standard of care surgery.
干预措施: Laboratory Biomarker Analysis (Other)
Diagnostic (fluorothymidine F-18 PET)
Patients receive fluorothymidine F-18 IV over 1 minute and undergo PET scan over 60 minutes 21 or less days prior to standard of care radiation therapy and 14 or less days prior to the standard of care surgery.
干预措施: Positron Emission Tomography (Procedure)
结局指标
主要结局
Change in Fluorothymidine F-18 mean standardized uptake value (SUV) as response to therapy.
时间窗: Pre (=< 21 days before radiation) and Post (=< 14 days before resection) radiation fluorothymidine F-18 positron emission tomography
Measured by mean SUV where the response to therapy is Pathological Response Disease change in volume of tumor (in cm3) utilizing Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) with magnetic resonance imaging (MRI). Mean, median, standard deviation, and range will be reported for continuous variables. Box plot, histogram plot, and density plot may be used to graphically show the distribution of the continuous endpoints.
次要结局
- Fluorothymidine F-18 mean SUV correlation with pathology mitotic index(Post (=< 14 days before resection) radiation fluorothymidine F-18 positron emission tomography)
- Fluorothymidine F-18 peak SUV correlation with pathology mitotic index(Post (=< 14 days before resection) radiation fluorothymidine F-18 positron emission tomography)
- Change in Fluorothymidine F-18 peak SUV as response to therapy(Pre (=< 21 days before radiation) and Post (=< 14 days before resection) radiation fluorothymidine F-18 positron emission tomography)
- Fluorothymidine F-18 peak SUV correlation with enhancement by MRI(Post (=< 14 days before resection) radiation fluorothymidine F-18 positron emission tomography)
- Volume of T2 enhanced MRI(Pre (=< 21 days before radiation) and Post (=< 14 days before resection) radiation fluorothymidine F-18 positron emission tomography)
研究者
Arthur Hung
Principal Investigator
OHSU Knight Cancer Institute