Pilot PET Imaging Study of [89Zr]DFO-YS5 for Detecting CD46 Positive Malignancy in Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Median Standardized Uptake Value averaged across lesions (SUVmax-avg)
研究概览
简要总结
This phase I trial tests the safety of [89Zr]DFO-YS5 positron emission tomography (PET) imaging and how well it works to detect CD46 positive cancer cells in patients with multiple myeloma. [89Zr]DFO-YS5 is an imaging agent called a radiopharmaceutical tracer. A radiopharmaceutical tracer uses a small amount of radioactive material that is injected into a vein to help image different areas of the body. [89Zr]DFO-YS5 targets a specialized protein called CD46, which is in certain multiple myeloma cancer cells, and [89Zr]DFO-YS5 PET scans may improve detection of multiple myeloma.
详细描述
PRIMARY OBJECTIVE:
I. To determine the sensitivity of metastatic lesion detection in multiple myeloma using zirconium Zr 89-DFO-YS5 ([89Zr]DFO-YS5 PET, as compared with fludeoxyglucose F-18 (18F-FDG) PET imaging.
SECONDARY OBJECTIVES:
I. To determine the safety of [89Zr]DFO-YS5. II. To determine the average organ uptake of [89Zr]DFO-YS5. III. To descriptively report the patterns of intra-tumoral uptake of [89Zr]DFO-YS5 on whole body PET, including by site of disease, uptake by tumor type, inter-tumoral and inter-patient heterogeneity, and tumor-to-background signal.
IV. To calculate the dosimetry of [89Zr]DFO-YS5 in patients with multiple myeloma.
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
- •Participants must have histologically or cytologically confirmed multiple myeloma by International Myeloma Working Group (IMWG) diagnostic criteria
- •At least one positive myelomatous lesion found on 18F-FDG PET/CT or PET/MRI. A positive lesion is defined as uptake greater than liver on FDG PET, based on the Italian myeloma criteria for PET use (IMPeTUs) criteria
- •Age >= 18 years
- •Total bilirubin =< 1.5 X institutional upper limit of normal (ULN)
- •Aspartate aminotransferase (AST) =< 3 X ULN
- •Alanine aminotransferase (ALT) =< 3 X ULN
- •Creatinine clearance >= 30 mL/min, calculated using the Cockcroft-Gault equation or serum creatinine <= 1.5x the institutional upper limit of normal.
- •Ability to understand a written informed consent document, and the willingness to sign it
排除标准
- •Any condition that, in the opinion of the principal investigator, would impair the participants' ability to comply with study procedures or interfere with the safety of the investigational regimen
- •Individuals who are pregnant or breastfeeding/chestfeeding.
- •- Breast-feeding/chest-feeding should be discontinued before administration of [89ZR]DFO-YS
- •Females of childbearing potential must have a negative urine or serum pregnancy test (i.e., human chorionic gonadotropin test) within 72 hours prior to administration of [89ZR]-DFO-YS
- •- If the urine pregnancy test is positive or equivocal, a confirmatory serum pregnancy test is required. In such cases, the individual must be excluded from participation if the serum pregnancy result is positive.
- •- A female is considered to be of childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), unless it is documented that the individual meets either of the following two criteria: (1) has reached a postmenopausal state ( >= 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and/or bilateral oophorectomy for removal of uterus and/or ovaries).
- •Individuals who are pregnant or breastfeeding/chestfeeding are excluded because there is an unknown but potential risk for adverse effects in the unborn/nursing child secondary to treatment of the study participant with [89ZR]-DFO-YS5
研究组 & 干预措施
Cohort A ([89Zr]DFO-YS5, single scan
Participants receive [89Zr]DFO-YS5 IV and undergo a single PET/CT or PET/MRI scan 5-7 days post-injection. Participants also receive fludeoxyglucose F-18 IV and undergo PET/CT or PET/MRI scan within 28 days prior to day 1
干预措施: Fludeoxyglucose F-18 (Other)
Cohort B ([89Zr]DFO-YS5, multiple scans
Participants receive [89Zr]DFO-YS5 IV and undergo four PET/CT or PET/MRI scans on days 1, 2, 3-4, and 5-7 post-injection. Participants also receive fludeoxyglucose F-18 IV and undergo PET/CT or PET/MRI scan within 28 days prior to day 1
干预措施: Fludeoxyglucose F-18 (Other)
Cohort B ([89Zr]DFO-YS5, multiple scans
Participants receive [89Zr]DFO-YS5 IV and undergo four PET/CT or PET/MRI scans on days 1, 2, 3-4, and 5-7 post-injection. Participants also receive fludeoxyglucose F-18 IV and undergo PET/CT or PET/MRI scan within 28 days prior to day 1
干预措施: Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) (Procedure)
Cohort A ([89Zr]DFO-YS5, single scan
Participants receive [89Zr]DFO-YS5 IV and undergo a single PET/CT or PET/MRI scan 5-7 days post-injection. Participants also receive fludeoxyglucose F-18 IV and undergo PET/CT or PET/MRI scan within 28 days prior to day 1
干预措施: Zirconium Zr 89-DFO-YS5 (Drug)
Cohort A ([89Zr]DFO-YS5, single scan
Participants receive [89Zr]DFO-YS5 IV and undergo a single PET/CT or PET/MRI scan 5-7 days post-injection. Participants also receive fludeoxyglucose F-18 IV and undergo PET/CT or PET/MRI scan within 28 days prior to day 1
干预措施: Positron Emission Tomography / Computed Tomography (PET/CT) (Procedure)
Cohort A ([89Zr]DFO-YS5, single scan
Participants receive [89Zr]DFO-YS5 IV and undergo a single PET/CT or PET/MRI scan 5-7 days post-injection. Participants also receive fludeoxyglucose F-18 IV and undergo PET/CT or PET/MRI scan within 28 days prior to day 1
干预措施: Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) (Procedure)
Cohort B ([89Zr]DFO-YS5, multiple scans
Participants receive [89Zr]DFO-YS5 IV and undergo four PET/CT or PET/MRI scans on days 1, 2, 3-4, and 5-7 post-injection. Participants also receive fludeoxyglucose F-18 IV and undergo PET/CT or PET/MRI scan within 28 days prior to day 1
干预措施: Zirconium Zr 89-DFO-YS5 (Drug)
Cohort B ([89Zr]DFO-YS5, multiple scans
Participants receive [89Zr]DFO-YS5 IV and undergo four PET/CT or PET/MRI scans on days 1, 2, 3-4, and 5-7 post-injection. Participants also receive fludeoxyglucose F-18 IV and undergo PET/CT or PET/MRI scan within 28 days prior to day 1
干预措施: Positron Emission Tomography / Computed Tomography (PET/CT) (Procedure)
结局指标
主要结局
Median Standardized Uptake Value averaged across lesions (SUVmax-avg)
时间窗: Up to 1 week
The median and range of SUVmax-average across all lesions in each study cohort will be descriptively reported using mediastinal blood pool and normal organ background uptake values.
Sensitivity of metastatic lesion
时间窗: Up to 1 week
Defined as the rate of lesions with positive uptake when compared against 18F-fluorodeoxyglucose (FDG) PET/computed tomography (CT) positivity. Sensitivity estimated based on lesion level without considering the location of the lesions or the possible intracorrelation of the lesions from the same patient by point estimate with its 95% confidence interval.
Median maximum standardized uptake value (SUVmax)
时间窗: Up to 1 week
The median and range of standardized uptake value maximum (SUVmax) (across all metastatic lesions per participant) in each study cohort will be descriptively reported using mediastinal blood pool and normal organ background uptake values.
次要结局
- Average organ uptake of [89Zr]DFO-YS5(Up to 1 week)
- Proportion of participants reporting treatment-related Adverse Events(Up to 35 days)
- Descriptive patterns of intra-tumoral uptake of [89Zr]DFO-YS5(Up to 1 week)
- Dosimetry measurements (Cohort B only)(Up to 1 week)
研究者
Robert Flavell, MD, PhD
Principal Investigator
University of California, San Francisco