Chemical-Shift-Encoded MRI for Active Bone Marrow Dosimetry in Radiopharmaceutical Therapy
研究概览
详细说明
This single-site, single-arm study will evaluate the accuracy of active bone marrow (ABM) segmentation with CSE-MRI by comparing to the established technique of FLT PET in patients with PSMA+ mCRPC who are scheduled to receive Lutetium-177 Prostate-Specific Membrane Antigen (177Lu-PSMA) (PLUVICTO®) Radiopharmaceutical Therapy (RPT) as standard of care. All standard of care testing, monitoring, and administration for 177Lu-PSMA RPT (PLUVICTO®) will be followed for this study.
Participants will receive 177Lu-PSMA RPT (PLUVICTO®) for a total of 6 doses, or until disease progression or unacceptable toxicity. Doses of 177Lu-PSMA RPT will be given at least 6 weeks apart. At the discretion of the prescribing physician, standard of care PSMA PET/MRI will be performed at any time during cycles 2-4, and also within 6 months of the final administration of 177Lu-PSMA RPT; during these scans, the CSE-MRI will also be acquired. Participants will be followed for 6 months following the final administration of 177Lu-PSMA RPT.
The primary endpoint is a calculation of the mean Dice similarity coefficient (DSC) between active bone marrow volumes derived from CSE-MRI and ¹⁸F-FLT PET across all enrolled patients. A mean DSC of ≥0.7 will indicate that CSE-MRI is a clinically acceptable alternative to FLT PET for identifying ABM.
With the exception of the research-related CSE-MRI and FLT PET scans, all assessments, laboratory tests, RPT, and imaging scans are standard of care.
研究类型
注册 (估计的)
阶段
- 第一阶段早期
联系人和位置
学习联系方式
- 姓名：Cancer Connect
- 电话号码：800-622-8922
- 邮箱：clinicaltrials@cancer.wisc.edu
学习地点
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Wisconsin
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Madison、Wisconsin、美国、53792
- University of Wisconsin Carbone Cancer Center
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Ability to understand and the willingness to sign a written informed consent document.
- Patients must be informed of the experimental nature of the study and its potential risks, and must sign institutional review board (IRB) approved consent form indicating such understanding.
- Individuals at least 18 years of age.
- Patients must have histologically or cytologically confirmed prostate cancer.
- Patients must be clinically deemed appropriate for standard of care Lu-177 PSMA RPT.
- Eastern Cooperative Oncology Group (ECOG) performance 0-2
- Patients must be able to comply with all study procedures, including having both the ability and willingness to lie flat for ≥ 30 minutes during imaging.
Exclusion Criteria:
- Patients receiving any concurrent therapy known to impact bone marrow (either stimulate or suppress the marrow, for example G-CSF).
- Patients treated with chemotherapy or 223Ra radiotherapy within 4 weeks.
- All acute toxic effects of any prior therapy (including surgery, radiation therapy, chemotherapy) must have resolved to a grade ≤ 2 according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5 (CTCAE).
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements per treating physician discretion.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Participants scheduled to receive 177Lu-PSMA
Males aged 18 years and older with metastatic PSMA-positive castration-resistant prostate cancer (CRPC) who are scheduled to receive 177Lu-PSMA (PLUVICTO®). Within 7 days prior to 177Lu-PSMA RPT, participants will receive an injection of FLT and then undergo a FLT PET to assess proliferating bone marrow and CSE-MRI to generate a fat fraction map on a GE SIGNA PET/MR scanner. Whole-body single photon emission computed tomography (SPECT/CT) imaging (2-3 bed positions) will be performed per standard of care on Day 0 (3 +/- 2 h), Day 1 (24 +/- 4 h), and Day 4 (96 +/- 24 h) post-177Lu-PSMA RPT infusion. As standard of care, participants will receive up to 6 infusions of 177Lu-PSMA RPT every 6 weeks at UW Health. |
Within 29 days prior to 177Lu-PSMA RPT, participants will undergo 18F-FLT PET to assess proliferating bone marrow and CSE-MRI to generate a fat fraction map on a GE SIGNA PET/MR scanner. This is expected to last 2-3 hours. FLT injections will be administered one hour before imaging for tracer uptake. Participants will receive an IV injection of up to 10 mCi (370 MBq) of 18F-FLT. The patient will receive 1 CSE-MRI/FLT PET scan prior to the start of therapy.
其他名称：
Within 29 days prior to 177Lu-PSMA RPT, participants will undergo 18F-FLT PET to assess proliferating bone marrow and CSE-MRI to generate a fat fraction map on a GE SIGNA PET/MR scanner. This is expected to last 2-3 hours. The patient will receive 1 CSE-MRI/FLT PET scan prior to the start of therapy. Up to 3 CSE-MRI scans will be completed as part of this study. At the physician's discretion, a single standard of care (SOC) mid-treatment PSMA PET/MRI can be performed any time during cycles 2-4, and a SOC post-treatment can be done within 6 months of final treatment. CSE-MRI will be acquired during these scans.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mean Dice similarity coefficient (DSC)
大体时间：up to 14 months
|
The mean Dice similarity coefficient (DSC) between active bone marrow volumes derived from CSE-MRI and ¹⁸F-FLT PET across all enrolled patients.
A mean DSC of ≥0.7 will indicate that CSE-MRI is a clinically acceptable alternative to FLT PET for identifying ABM
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up to 14 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Difference in Mean Tumor Absorbed Dose (Gy)
大体时间：up to 14 months
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Difference in mean tumor absorbed dose (Gy) across three lesion-segmentation methods, with segmentation performance characterized by DSC relative to physician manual contours.
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up to 14 months
|
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Variance in Tumor and Bone Marrow Volume
大体时间：up to 14 months
|
Repeatability will be measured by variance in tumor and bone marrow volumes.
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up to 14 months
|
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Variance in Tumor and Bone Marrow Doses
大体时间：up to 14 months
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Repeatability will be measured by variance in tumor and bone marrow doses
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up to 14 months
|
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Difference in Mean Absorbed Dose (Gy)
大体时间：up to 14 months
|
Difference in mean absorbed dose (Gy) between conventional and CSE-MRI-based ABM dosimetry methods
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up to 14 months
|
合作者和调查者
合作者
调查人员
- 首席研究员：Michael Lawless, PhD、UW School of Medicine and Public Health
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2026-0693
- Protocol Version (其他标识符：UW Madison)
- SMPH / Human Oncology (其他标识符：UW Madison)
- UW26012 (注册表标识符：OnCore ID)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 共享支持信息类型
- 研究方案
- 树液
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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