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Recruiting EARLY_Phase 1 NCT05065736

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

Trial Parameters

Condition Metastatic Cancer
Sponsor Roberto Vargas
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 4
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-03-06
Completion 2026-06
Interventions
18F-Clofarabine

Brief 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.

Eligibility 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 writ

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