RECRUITING

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

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Conditions

Metastatic CancerCarcinomaAdenocarcinoma18F-ClofarabineDiagnostic ImagingCancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2023-03-06
Study Completion:2025-06-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05065736

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically or cytologically proven metastatic cancer (including carcinoma, adenocarcinoma, sarcoma, or neuroendocrine cancer).
  2. * Subjects must have metastatic disease, confirmed by imaging, typically a CT scan of the chest/abdomen/pelvis.
  3. * Subjects must have measurable disease per RECIST 1.1
  4. * Over 18 years of age
  5. * ECOG performance status 0-1
  6. * Adequate organ function as defined by the following criteria (labs may be no more than 4 weeks prior to the screening date):
  7. * 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)
  8. * Total serum bilirubin \<= 2.0 x ULN
  9. * Absolute neutrophil count (ANC) \>= 1500/uL
  10. * Platelets \>= 75,000/uL
  11. * Hemoglobin \>= 8.0 g/dL
  12. * Serum calcium \<= 12.0 mg/dL
  13. * Serum creatinine \<= 2.9 mg/dL
  14. * Subjects must have the ability to understand and the willingness to sign a written informed consent document
  15. * Patient is able to remain still for the duration of the imaging procedure (up to one hour).
  1. * 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.
  2. * Pregnancy or breastfeeding (pregnant or breastfeeding women are excluded from this study because study drugs have the potential for teratogenic or abortifacient effects.
  3. * 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.

Contacts and Locations

Study Contact

Roberto Vargas, MD
CONTACT
866-223 8100
TaussigResearch@ccf.org

Principal Investigator

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

Study Locations (Sites)

Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
United States

Collaborators and Investigators

Sponsor: Roberto Vargas

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-06
Study Completion Date2025-06-05

Study Record Updates

Study Start Date2023-03-06
Study Completion Date2025-06-05

Terms related to this study

Keywords Provided by Researchers

  • 18F-Clofarabine
  • Diagnostic Imaging
  • Cancer

Additional Relevant MeSH Terms

  • Metastatic Cancer
  • Carcinoma
  • Adenocarcinoma