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

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ClinicalTrials.gov Identifier: NCT05065736
Recruitment Status : Recruiting
First Posted : October 4, 2021
Last Update Posted : May 18, 2022
Sponsor:
Information provided by (Responsible Party):
Omar Mian, Case Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE September 23, 2021
First Posted Date  ICMJE October 4, 2021
Last Update Posted Date May 18, 2022
Estimated Study Start Date  ICMJE September 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2021)		 Evaluate CFA as a PET imaging agent [ Time Frame: up to 60 minutes after CFA PET ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2021)
  • Correlate CFA uptake with conventional imaging [ Time Frame: up to 3 months after CFA PET ]
    Correlate CFA uptake with conventional anatomic imaging using RECIST criteria to establish change over time and differences from participants' baseline scans.
  • Correlate CFA uptake with PFS [ Time Frame: up to 12 months after CFA PET ]
    Correlate changes in CFA uptake (SUV) with disease progression as determined by standard of care surveillance imaging.
  • Correlate CFA uptake with OS [ Time Frame: up to 12 months after CFA PET ]
    Correlate changes in CFA uptake with participant outcomes as measured by all cause mortality/overall survival (OS).
  • Adverse Events [ Time Frame: within 48 hrs of radiotracer administration ]
    Proportion of participants who develop any side effects/adverse events associated with radiotracer infusions.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Using a PET Imaging Agent, 18F-Clofarabine (CFA), to Measure Deoxycytidine Kinase Activity in Metastatic Cancer
Official Title  ICMJE 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
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.
Detailed Description

The participants will receive a CFA injection into a vein in their arm. The imaging drug is attracted to and taken into certain cells in the body, including cancer cells. 18F-Clofarabine (CFA) is experimental because it is not approved by the Food and Drug Administration (FDA).

The participants will be observed for side effects, and about 1 hour later, they will receive a PET/CT scan. Additionally, they will be contacted the next day to inquire again about any side effects. If the participant's routine care involves repeat imaging of cancer, then the CFA PET/CT scan will be repeated at that time, which could be a month to about 4 months after the first CFA PET/CT scan.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Metastatic Cancer
  • Carcinoma
  • Adenocarcinoma
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: 18F-Clofarabine
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
Intervention: Drug: 18F-Clofarabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 23, 2021)		 15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2024
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically proven carcinoma or adenocarcinoma. Histologies other than carcinoma/adenocarcinoma will not be eligible.
  • 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:

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Omar Mian, MD 866-223 8100 TaussigResearch@ccf.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05065736
Other Study ID Numbers  ICMJE CASE4Y21
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: This is a feasibility study of a novel PET-scan imaging agent and IPD is not needed for interpretation of the data
Current Responsible Party Omar Mian, Case Comprehensive Cancer Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Omar Mian
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Omar Mian, MD Cleveland Clinic, Case Comprehensive Cancer Center
PRS Account Case Comprehensive Cancer Center
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP