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18F-Clofarabine PET Imaging for Cancer
Phase < 1
Recruiting
Led By Roberto Vargas, MD
Research Sponsored by Roberto Vargas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Over 18 years of age
Patient is able to remain still for the duration of the imaging procedure (up to one hour)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 minutes after cfa pet
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether a new imaging agent, 18F-Clofarabine, can be used to show pyrimidine metabolism in order to better predict whether cancer drugs will be effective.
Who is the study for?
This trial is for adults over 18 with metastatic carcinoma or adenocarcinoma, confirmed by imaging. Participants must have measurable disease, be able to stay still for an hour during imaging, and have normal organ function levels. It's not suitable for those with recent severe heart issues, significant bleeding, stroke risks, or pregnant/breastfeeding women.
What is being tested?
The study tests if a new PET/CT imaging agent called 18F-Clofarabine (CFA) can effectively image cancer metabolism related to pyrimidine metabolism—a factor in how well certain cancer drugs work.
What are the potential side effects?
Specific side effects of the PET imaging agent are not detailed here but generally include potential allergic reactions to the tracer substance and discomfort from remaining still during the procedure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18 years old.
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I can stay still for up to an hour for a scan.
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My cancer is confirmed as carcinoma or adenocarcinoma.
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My cancer has spread and this was confirmed by a CT scan.
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I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 60 minutes after cfa pet
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 minutes after cfa pet
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Evaluate CFA as a PET imaging agent
Secondary study objectives
Adverse Events
Correlate CFA uptake with OS
Correlate CFA uptake with PFS
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: 18F-ClofarabineExperimental Treatment1 Intervention
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
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Who is running the clinical trial?
Roberto VargasLead Sponsor
Omar MianLead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
Roberto Vargas, MDPrincipal InvestigatorCleveland Clinic, Case Comprehensive Cancer Center
Omar Mian, MDPrincipal InvestigatorCleveland Clinic, Case Comprehensive Cancer Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 18 years old.I can stay still for up to an hour for a scan.I have not had any major heart problems in the last 6 months.My cancer is confirmed as carcinoma or adenocarcinoma.I can understand and am willing to sign the consent form.My organs are functioning well.My cancer has spread and this was confirmed by a CT scan.I am fully active or can carry out light work.
Research Study Groups:
This trial has the following groups:- Group 1: 18F-Clofarabine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.