NCT02349022已完成2 期
A Phase 2 Study - Comparison Of Positron Emission Tomography (PET/CT) With [89Zr]-Df-IAb2M and [111In]-Capromab Pendetide in the Detection of Prostate Cancer Pre-prostatectomy
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Compare sensitivity/specificity/PPV/NPV/Accuracy of [111In] capromab pendetide SPECT/CT to [89Zr]-Df-IAB2M PET/CT as confirmed by pathology
研究概览
简要总结
The purpose of this study is to compare the diagnostic performance of [89Zr]-Df-IAB2M PET/CT with that of [111In]-capromab pendetide as an immuno PET tracer in the detection of prostate cancer pre-prostatectomy as confirmed by pathology.
Individuals participating in this study will have a [111In]-capromab pendetide scan, as well as a PET scan following the injection of [89Zr]-Df-IAB2M.
详细描述
IAB2M is an approximately 80 kDA molecular weight antibody fragment (a "Minibody") chelated with Desferroxamine and radiolabeled with 89Zr. [89Zr]-Df-IAB2M targets the extracellular domain of Prostate Membrane Specific Antigen (PSMA) expressed on most primary and metastatic prostate cancer lesions.
[111In]-capromab pendetide (Prostascint®) is an FDA approved imaging agent targeting the intracellular domain of PSMA. It is anticipated that [89Zr]-Df-IAB2M will outperform Prostascint® because of this targeting difference.
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
- 否
入选标准
- •Patients must meet ALL criteria listed below for entry:
- •Age ≥ 18 years
- •Signed, written IRB-approved informed consent
- •Patients newly diagnosed with biopsy-proven prostate cancer, thought to be a candidate for prostatectomy after standard diagnostic evaluation (e.g. chest x-ray, CT scan or MRI) who are at high-risk for pelvic lymph node metastases.
- •High Risk defined as:
- •Gleason score ≥ 8 or
- •Gleason 4+3 with a PSA > 10 or
- •PSA > 20 ng/mL or
- •Patients scheduled for a [111In]-capromab pendetide scan or had a recent [111In]-capromab pendetide scan within 28 days of screening visit or would be willing to undergo a [111In]-capromab pendetide scan
- •Karnofsky Performance status of ≥ 60
- •Life expectancy of at least 6 months
- •Patients with any previous history of another malignancy (other than in-situ cancer, basal or squamous cell skin cancer) must be disease free for a period of three years.
- •Acceptable liver function:
- •Bilirubin ≤ 1.5 times upper limit of normal or <3 x ULN for patients with Gilbert's disease
- •AST (SGOT), ALT (SGPT) and Alkaline phosphatase ≤ 2.5 times upper limit of normal (if liver metastases are present, then ≤ 5 x ULN is allowed)
- •Acceptable renal function:
- •Serum creatinine within normal limits, OR
- •calculated creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
- •Acceptable hematologic status:
- •Granulocyte ≥ 1500 cells/mm3
- •Platelet count ≥ 150,000 (plt/mm3)
- •Hemoglobin ≥ 9 g/dL
- •For men of child-producing potential, the use of effective contraceptive methods during the study
排除标准
- •Patients will be excluded from entry if ANY of the criteria listed below are met:
- •New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months
- •Unstable arrhythmia, or evidence of ischemia on ECG
- •Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
- •Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy for prostate cancer.
- •Unwillingness or inability to comply with procedures required in this protocol
- •Known infection with HIV, hepatitis B, or hepatitis C
- •Serious nonmalignant disease (eg, hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
- •Previous [111In]-capromab pendetide image test
结局指标
主要结局
Compare sensitivity/specificity/PPV/NPV/Accuracy of [111In] capromab pendetide SPECT/CT to [89Zr]-Df-IAB2M PET/CT as confirmed by pathology
时间窗: 6 weeks
次要结局
- Assess the safety of a single dose of [89Zr]-Df-IAB2M(Day 1 through Day 13)
- Histopathologic correlation of PSMA expression and prostate cancer from surgical or biopsy specimens with uptake of [89Zr]-Df-IAB2M on PET/CT(Day 1 through Day 13)
- Compare the sensitivity/specificity/PPV/NPV/Accuracy of conventional imaging (CT/MRI/Bone scan) to [89Zr]-Df-IAB2M PET/CT using pathology for ground truth of disease status(Day 1 through Day 13)
- Compare the concordant and discordant rate for positive/negative areas of uptake between [111In]-Capromab pendetide SPECT/CT to [89Zr]-Df-IAB2M PET/CT using pathology for ground truth of disease status(Day 1 through Day 13)
研究者
研究点 (2)
Loading locations...
相似试验
招募中
2 期
An Investigational Scan (89Zr-DFO-GmAb PET/CT) Compared to Contrast-Enhanced CT for the Detection of Recurrent Clear Cell Renal Cell Cancer After Surgery Comparing Carbonic Anhydrase IX (CAIX) PET CT to Conventional PET CT for Post-Op Staging in Kidney CancerSarcomatoid Renal Cell CarcinomaStage II Renal Cell CancerStage III Renal Cell CancerStage IV Renal Cell CancerClear Cell Renal Cell CarcinomaNCT06447103Jonsson Comprehensive Cancer Center91
已完成
1 期
⁸⁹Zr-Df-IAB22M2C PET/CT in Patients With Selected Solid Malignancies or Hodgkin's LymphomaPositron-Emission TomographyImmunomodulationMetastatic Solid MalignanciesHodgkin LymphomaNCT03107663ImaginAb, Inc.15
已完成
1 期
Clinical and Molecular Correlates of Positron Emission Tomography (PET) With 89Zr-DFO-huJ591 in Metastatic Prostate CancerProstate CancerNCT01543659Memorial Sloan Kettering Cancer Center77
已完成
不适用
Evaluation of Preoperative Investigations in Patients With Liver CancerPrimary Liver CancerLiver MetastasisNCT00408122Odense University Hospital77
Unknown
早期 1 期
68Ga-BNOTA-PRGD2 PET/CT in Patients With Rheumatoid ArthritisRheumatoid ArthritisNCT01940926Peking Union Medical College Hospital50