IRB Study Number 21-925
Status Recruiting
Institute Taussig Cancer Institute
Description
2.1 Primary Objective
The primary objective of this pilot study is to evaluate the feasibility of administration and biodistribution of CFA as a PET imaging agent.
2.2 Secondary Objective(s)
(i) Correlate CFA uptake with conventional imaging and RECIST evaluation, if any, or other clinical data if available;
(ii) Correlate CFA uptake with progression free survival (PFS) and overall survival (OS). As part of the feasibility evaluation, toxicity profile, using Common Terminology Criteria for Adverse Events (CTCAE, v. 5) as end-points, will be recorded.
(iii) Measure adverse events
Inclusion Criteria
4.1.1 Histologically or cytologically proven carcinoma or adenocarcinoma. Histologies other than carcinoma/adenocarcinoma will not be eligible.
4.1.2 Subjects must have metastatic disease, confirmed by imaging, typically a CT scan of the chest/abdomen/pelvis.
4.1.3 Subjects must have measurable disease per RECIST 1.1
4.1.4 Over 18 years of age
4.1.4 ECOG performance status 0-1
4.1.5 Adequate organ function as defined by the following criteria:
Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) 2.5 x laboratory upper limit of normal (ULN)
Total serum bilirubin 2.0 x ULN
Absolute neutrophil count (ANC) 1500/L
Platelets 75,000/L
Hemoglobin 8.0 g/dL
Serum calcium 12.0 mg/dL
Calculated Creatinine Clearance ≥ 60 mL/min. Calculated using Cockcroft-Gault formula: Creatinine Clearance = [[140 - age(yr)] multiplied by body weight(kg)]/[72 multiplied by serum Cr(mg/dL)] (multiply total by 0.85 for women).
4.1.6 Subjects must have the ability to understand and the willingness to sign a written informed consent document.
4.1.7 Patient is able to remain still for duration of imaging procedure (up to one hour).
Exclusion Criteria
4.2.1 Within 6 months prior to enrollment on this study: myocardial infarction, severe/unstable angina, severe peripheral vascular disease (claudication) or procedure on peripheral vasculature, coronary/peripheral artery bypass graft, New York Heart Association grade II or greater congestive heart failure, cerebrovascular accident or transient ischemic attack, clinically significant bleeding or pulmonary embolism.
4.2.2 Pregnancy or breastfeeding (pregnant or breastfeeding women are excluded from this study because study drugs have the potential for teratogenic or abortifacient effects.
4.2.3 Other severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
