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18F-Clofarabine (CFA) PET Imaging for Metastatic Cancer

This study is testing a new imaging method called 18F-Clofarabine (CFA) PET/CT for people with metastatic cancer (cancer that has spread). The goal is to see if CFA can help doctors understand how cancer cells use energy (pyrimidine metabolism). This information could help predict if certain cancer drugs, like gemcitabine, might work well. You would receive an injection of 18F-Clofarabine (CFA) and then have a PET/CT scan. The study is looking for 4 participants with metastatic cancer, including carcinoma or adenocarcinoma, who are at least 18 years old and have measurable disease.

Study design
This is an interventional study with a planned enrollment of 4 participants. It is testing 18F-Clofarabine (CFA) as a PET imaging agent.
What's involved
You would receive an injection of 18F-Clofarabine (CFA) and then have a PET/CT scan about an hour later. You would also be contacted the next day to check for side effects. If your routine care includes repeat imaging, the CFA PET/CT scan might be repeated up to 365 days later.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 60 minutes after the initial CFA PET scan to evaluate the imaging agent. If routine care involves repeat imaging, a follow-up scan could occur up to 365 days later.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05065736

Using a PET Imaging Agent, 18F-Clofarabine (CFA), to Measure Deoxycytidine Kinase Activity in Metastatic Cancer

Terminated
EARLY_PHASE1Ages 18+InterventionalDiagnostic
Roberto Vargas
~5 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:18F-Clofarabine

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluate CFA as a PET imaging agent
Measured over up to 60 minutes after CFA PET

Conditions

Metastatic Cancer
Carcinoma
Adenocarcinoma

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NCT05065736

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Cleveland Clinic, Case Comprehensive Cancer Center

    Cleveland, Ohiono site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Roberto Vargas, MD · PRINCIPAL_INVESTIGATOR · Cleveland Clinic, Case Comprehensive Cancer Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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
ECOG performance status 0-1
Adequate organ function as defined by the following criteria (labs may be no more than 4 weeks prior to the screening date):
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/uL
Platelets \>= 75,000/uL
Hemoglobin \>= 8.0 g/dL
Serum calcium \<= 12.0 mg/dL
Serum creatinine \<= 2.9 mg/dL
Subjects must have the ability to understand and the willingness to sign a written informed consent document
Patient is able to remain still for the duration of the imaging procedure (up to one hour).

Exclusion

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.

What this trial measures

  • Evaluate CFA as a PET imaging agentup to 60 minutes after CFA PET

    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.