Using a new imaging agent to measure cancer metabolism in metastatic cancer
18F-Clofarabine (CFA) as a PET Imaging Agent to Measure Deoxycytidine Kinase (DCK) Activity in Metastatic Cancer, as a Candidate Predictive Biomarker for Response to DCK-dependent Drugs Such as Gemcitabine
This study is testing a new imaging agent to see if it can help doctors understand how cancer cells are using energy in patients with metastatic cancer and predict how well certain treatments might work.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 4 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Case Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05065736 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a novel imaging agent, 18F-Clofarabine (CFA), in assessing pyrimidine metabolism in metastatic cancer patients. Participants will receive an injection of CFA, which is designed to be taken up by cancer cells, followed by a PET/CT scan to visualize the cancer's metabolic activity. The study aims to determine if this imaging technique can predict the efficacy of certain cancer treatments, such as gemcitabine. Participants will be monitored for side effects and may undergo repeat imaging if their routine care requires it.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with histologically or cytologically proven metastatic cancer and measurable disease.
Not a fit: Patients without metastatic cancer or those with significant organ dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new diagnostic tool to better tailor cancer treatments based on individual metabolic profiles.
How similar studies have performed: While the use of imaging agents in cancer metabolism is an emerging field, this specific approach with 18F-Clofarabine is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic, Case Comprehensive Cancer Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Roberto Vargas, MD — Cleveland Clinic, Case Comprehensive Cancer Center
- Study coordinator: Roberto Vargas, MD
- Email: TaussigResearch@ccf.org
- Phone: 866-223 8100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.