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RECRUITING

NCT05065736

EARLY_PHASE1

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

Sponsor: Roberto Vargas

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-03-06

Completion Date

2026-06

Last Updated

2026-03-19

Healthy Volunteers

Conditions

Metastatic Cancer Carcinoma Adenocarcinoma

Interventions

DRUG

18F-Clofarabine

The 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.

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.

Locations (1)

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, United States