Using a PET Imaging Agent, 18F-Clofarabine (CFA), to Measure Deoxycytidine Kinase Activity in Metastatic Cancer
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorRoberto Vargas
About this trial
The purpose of this study is to evaluate whether a new type of imaging study, called 18F-Clofarabine (CFA) PET/CT, can be used to image cancer pyrimidine metabolism in participants.
PET (positron emission tomography) imaging is a way of looking at cancers that can reveal cancer metabolism. Presently, however, there are no imaging agents in routine use to look at an aspect of cancer metabolism (pyrimidine metabolism) that dictates whether certain cancer drugs, e.g., gemcitabine, are likely to be taken into the cancer cells. This clinical trial will be testing whether 18F-Clofarabine (CFA) could be an imaging agent to measure this aspect of cancer metabolism.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically or cytologically proven metastatic cancer (including carcinoma, adenocarcinoma, sarcoma, or neuroendocrine cancer).
Subjects must have metastatic disease, confirmed by imaging, typically a CT scan of the chest/abdomen/pelvis.
Subjects must have measurable disease per RECIST 1.1
Over 18 years of age
Disqualifiers
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.
Pregnancy or breastfeeding (pregnant or breastfeeding women are excluded from this study because study drugs have the potential for teratogenic or abortifacient effects.
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.
Trial design
Design model
Single group
Treatments tested in this trial
18F-Clofarabine
DrugThe participants enrolled will receive a baseline CFA PET/CT evaluation. Then, the participants will undergo the routine follow up would normally occur for their cancer and its treatment. If this routine follow up and care involves repeat imaging of the cancer, then the CFA PET/CT scan will be repeated at that time (timed according to standard-of-care follow-up imaging), which is expected between a month to about 4 months after the first CFA PET/CT scan. The study period will end 24 hours after this repeat PET/CT scan.
Treatment groups
4 Participants
are divided into 1 treatment groupGroup A: 18F-ClofarabineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Evaluate CFA as a PET imaging agent
Establish the image-based biodistribution of CFA, a new tracer for imaging DCK enzyme activity. DCK converts the inactive prodrug clofarabine into its active form. Thus, the degree of DCK expression in normal and abnormal tissues may predict drug effects and effectiveness. The uptake of the radiotracer (SUVs) will be measured quantitatively from PET images taken at 60 min post-injection of \[18F\]CFA.
Time frame
up to 60 minutes after CFA PETSecondary outcomes
1
Correlate CFA uptake with conventional imaging
Correlate CFA uptake with conventional anatomic imaging using RECIST criteria to establish change over time and differences from participants' baseline scans.
Time frame
up to 3 months after CFA PET2
Correlate CFA uptake with PFS
Correlate changes in CFA uptake (SUV) with disease progression as determined by standard of care surveillance imaging.
Time frame
up to 12 months after CFA PET3
Correlate CFA uptake with OS
Correlate changes in CFA uptake with participant outcomes as measured by all cause mortality/overall survival (OS).
Time frame
up to 12 months after CFA PET4
Adverse Events
Proportion of participants who develop any side effects/adverse events associated with radiotracer infusions.
Time frame
within 48 hrs of radiotracer administrationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Roberto Vargas
Lead sponsor
Case Comprehensive Cancer Center
Sponsor institution
Source ClinicalTrials.gov