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 : Not yet recruiting
First Posted : October 4, 2021
Last Update Posted : October 4, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Cancer Carcinoma Adenocarcinoma||Drug: 18F-Clofarabine||Early Phase 1|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||October 2021|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||June 2024|
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
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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05065736
|Contact: Omar Mian, MD||866-223 8100||TaussigResearch@ccf.org|
|United States, Ohio|
|Cleveland Clinic, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106|
|Contact: Omar Mian, MD PhD 866-223-8100 firstname.lastname@example.org|
|Principal Investigator:||Omar Mian, MD||Cleveland Clinic, Case Comprehensive Cancer Center|