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

NCT05065736 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: CASE4Y21
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Cancer; Carcinoma; Adenocarcinoma

Keywords

18F-Clofarabine; Diagnostic Imaging; Cancer

Outcome Measures

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.

  up to 60 minutes after CFA PET

Secondary Outcomes (4)

• Correlate CFA uptake with conventional imaging

  up to 3 months after CFA PET

• Correlate CFA uptake with PFS

  up to 12 months after CFA PET

• Correlate CFA uptake with OS

  up to 12 months after CFA PET

• Adverse Events

  within 48 hrs of radiotracer administration

Study Arms (1)

18F-Clofarabine

EXPERIMENTAL

18F-Clofarabine as PET imaging agent for measuring the activity of deoxycytidine kinase (DCK) in various normal and abnormal tissues in cancer participants before and after therapy

Drug: 18F-Clofarabine

Interventions

18F-Clofarabine DRUG

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.

18F-Clofarabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Roberto Vargas: lead

Study Sites (1)

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis; Carcinoma; Adenocarcinoma; Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Roberto Vargas, MD

  Cleveland Clinic, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberto Vargas, MD

CONTACT

866-223 8100; TaussigResearch@ccf.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 4, 2021
• Study Start: March 6, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)