Using a PET Imaging Agent, 18F-Clofarabine (CFA), to Measure Deoxycytidine Kinase Activity in Metastatic Cancer
- Conditions
- Metastatic CancerCarcinomaAdenocarcinoma
- Registration Number
- NCT05065736
- Lead Sponsor
- Omar Mian
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 4
Inclusion Criteria:<br><br> - Histologically or cytologically proven metastatic cancer (including carcinoma,<br> adenocarcinoma, sarcoma, or neuroendocrine cancer).<br><br> - Subjects must have metastatic disease, confirmed by imaging, typically a CT scan of<br> the chest/abdomen/pelvis.<br><br> - Subjects must have measurable disease per RECIST 1.1<br><br> - Over 18 years of age<br><br> - ECOG performance status 0-1<br><br> - Adequate organ function as defined by the following criteria (labs may be no more<br> than 4 weeks prior to the screening date):<br><br> - Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase<br> [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic<br> transaminase [SGPT]) <= 2.5 x laboratory upper limit of normal (ULN)<br><br> - Total serum bilirubin <= 2.0 x ULN<br><br> - Absolute neutrophil count (ANC) >= 1500/uL<br><br> - Platelets >= 75,000/uL<br><br> - Hemoglobin >= 8.0 g/dL<br><br> - Serum calcium <= 12.0 mg/dL<br><br> - Serum creatinine <= 2.9 mg/dL<br><br> - Subjects must have the ability to understand and the willingness to sign a written<br> informed consent document<br><br> - Patient is able to remain still for the duration of the imaging procedure (up to one<br> hour).<br><br>Exclusion Criteria:<br><br> - Within 6 months prior to enrollment on this study: myocardial infarction,<br> severe/unstable angina, severe peripheral vascular disease (claudication) or<br> procedure on peripheral vasculature, coronary/peripheral artery bypass graft, New<br> York Heart Association grade II or greater congestive heart failure, cerebrovascular<br> accident or transient ischemic attack, clinically significant bleeding or pulmonary<br> embolism.<br><br> - Pregnancy or breastfeeding (pregnant or breastfeeding women are excluded from this<br> study because study drugs have the potential for teratogenic or abortifacient<br> effects.<br><br> - Other severe acute or chronic medical or psychiatric conditions or laboratory<br> abnormalities that may increase the risk associated with study participation or<br> study drug administration, or may interfere with the interpretation of study<br> results, and in the judgment of the investigator would make the patient<br> inappropriate for entry into this study.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate CFA as a PET imaging agent
- Secondary Outcome Measures
Name Time Method Correlate CFA uptake with conventional imaging;Correlate CFA uptake with PFS;Correlate CFA uptake with OS;Adverse Events