NCT01916135已完成1 期
PET Imaging of Cancer Patients Using [18F]-SKI-249380, a Radiolabeled Dasatinib-Derivative
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- pharmacokinetics
研究概览
简要总结
This study is the first time that a new experimental drug called [18F]-SKI-249380 is being used in people. [18F]-SKI-249380 is not a therapeutic drug. [18F]-SKI-249380 is a drug that will be used with PET scanners to 'see' where [18F]-SKI-249380 goes in the body, after its injected. The researchers believe that scans with [18F]-SKI-249380 might be able to find tumors in patients.
This study is being done to see how long [18F]-SKI-249380 stays in the blood, when it is given to people in tiny amounts by an injection into a vein in their arm, and to see where [18F]-SKI-249380 goes in the body. If the results of this trial are good, then the study doctors plan to use [18F]-SKI-249380 in another trial to see if scans with [18F]-SKI-249380 are better for finding tumors compared to the standard types of scans that doctors use.
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
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with history of histologically-confirmed neoplasm of any of the following classifications: solid malignancy, myeloid neoplasm, lymphoid neoplasm.
- •Histology confirmed by MSKCC Department of Pathology.
- •Disease that is either:
- •Radiologically-measurable or evaluable as defined by tumor response criteria from an MSKCC-IRB approved clinic research protocol.
- •Detectable by biopsy (eg, bone marrow) and/or peripheral blood assays obtained within 6 weeks of study enrollment
- •Age between 21-90
- •Negative serum pregnancy test for females of child-bearing age (11-55 years) and potential (ie, women who were not postmenopausal before the start of ongoing treatment, if applicable; and who have not had a surgical intervention whose intent or effect is sterilization, such as tubal ligation or hysterectomy.)
- •Not breast-feeding, if applicable.
排除标准
- •Refusal or inability to discontinue medications or other substances (eg, foods or dietary supplements) that may affect [18F]-SKI-249380 metabolism. Notably, as dasatinib metabolism is CYP3A4-dependent, the metabolism of [18F]-SKI-249380 may be altered by inhibitors and inducers of cytochrome P450 isoenzyme CYP3A
- •The acceptability of medications and other substances used by the patient will be determined by the study investigators.
- •Inability or refusal to have at least one peripheral intravenous line for intravenous access (as applicable to the day of [18F]-SKI-249380 injection and blood draws.)
- •Refusal or inability to tolerate the scanning procedure (e.g., due to claustrophobia)
- •Hepatic: from assays obtained <2 weeks prior to study enrollment
- •Bilirubin > 1.5 x institutional upper limit of normal (ULN)
- •AST/ALT >2.5 x ULN
- •Albumin < 2 g/dl
- •GGT > 2.5 x ULN IF Alkaline phosphatase > 2.5 x ULN.
- •Renal: Creatinine >1.5 x ULN or creatinine clearance < 60 mL/min, from assays obtained <2 weeks prior to study enrollment
- •Acute major illness (e.g., unstable cardiovascular condition, etc.)
结局指标
主要结局
pharmacokinetics
时间窗: approximately 1, 5, 15, 30, and 90 minutes and 3 hours, post-injection
This will be evaluated by non-invasive blood- and PET-based assays, at multiple time points. Blood/plasma assayed by standard radio-HPLC and/or TCA methods for quantitating activity, metabolites, and plasma protein binding will be performed.
次要结局
- metabolism(approximately 1, 5, 15, 30, and 90 minutes and 3 hours, post-injection)
- biodistribution(approximately 1, 5, 15, 30, and 90 minutes and 3 hours, post-injection)
- radiation dosimetry(approximately 1, 5, 15, 30, and 90 minutes and 3 hours, post-injection)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
A Phase I Study: PET Imaging of Cancer Patients Using [18F] 4-L-Fluoroglutamine (2S,4R)Solid MalignancyLymphomaNCT01697930Memorial Sloan Kettering Cancer Center67
已完成
1 期
18F-FPPRGD2 PET/CT or PET/MRI in Predicting Early Response in Patients With Cancer Receiving Anti-Angiogenesis TherapyAdult Giant Cell GlioblastomaAdult GlioblastomaAdult GliosarcomaMetastatic Squamous Neck Cancer With Occult Primary Squamous Cell CarcinomaRecurrent Adenoid Cystic Carcinoma of the Oral CavityRecurrent Adult Brain TumorRecurrent Basal Cell Carcinoma of the LipRecurrent Colon CancerRecurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal CavityRecurrent Hypopharyngeal CancerRecurrent Inverted Papilloma of the Paranasal Sinus and Nasal CavityRecurrent Laryngeal CancerRecurrent Lip and Oral Cavity CancerRecurrent Lymphoepithelioma of the NasopharynxRecurrent Lymphoepithelioma of the OropharynxRecurrent Metastatic Squamous Neck Cancer With Occult PrimaryRecurrent Midline Lethal Granuloma of the Paranasal Sinus and Nasal CavityRecurrent Mucoepidermoid Carcinoma of the Oral CavityRecurrent Nasopharyngeal CancerRecurrent Non-small Cell Lung CancerRecurrent Oropharyngeal CancerRecurrent Pancreatic CancerRecurrent Paranasal Sinus and Nasal Cavity CancerRecurrent Rectal CancerRecurrent Renal Cell CancerRecurrent Salivary Gland CancerStage IIIA Breast CancerStage IIIA Non-small Cell Lung CancerStage IIIB Breast CancerStage IIIB Non-small Cell Lung CancerStage IIIC Breast CancerStage IV Breast CancerStage IV Non-small Cell Lung CancerStage IV Pancreatic CancerStage IV Renal Cell CancerMale Breast CancerStage IVA Colon CancerStage IVA Rectal CancerStage IVA Salivary Gland CancerStage IVB Colon CancerStage IVB Salivary Gland CancerStage IVC Salivary Gland CancerUnspecified Adult Solid Tumor, Protocol SpecificTongue CancerNCT01806675Sanjiv Sam Gambhir25
撤回
2 期
18F-CP18 Imaging Studies for Cancer Treatment With BirinapantOvarian NeoplasmsFallopian Tube NeoplasmsFallopian Tube CancerOvarian CancerNCT01766622National Institutes of Health Clinical Center (CC)
已完成
不适用
Combined F-18 NaF and F-18 FDG PET/CT for Evaluation of MalignancyNeoplasmsNCT00725387Stanford University214
已完成
早期 1 期
Fluciclovine F18 PET/CT in Identifying the Origin of Head and Neck Squamous Cell Carcinoma in Patients With Metastatic Cervical Nodal DiseaseMetastatic Head and Neck Squamous Cell CarcinomaMetastatic Squamous Cell Carcinoma in Cervical Lymph NodeNCT03868020M.D. Anderson Cancer Center16