New PET scan could help doctors choose the right chemo for cancer patients
NCT ID NCT05065736
First seen Jun 26, 2026 · Last updated Aug 07, 2026 · Updated 2 times
Summary
This early-phase trial is testing whether a new radioactive tracer called 18F-Clofarabine (CFA) can be used in PET scans to measure an enzyme activity in cancer cells that may predict how well certain drugs like gemcitabine work. Four adults with metastatic cancer will receive the tracer and undergo PET/CT imaging. The study aims to see if the tracer's uptake in tumors correlates with standard imaging and disease progression.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 18F-Clofarabine (a radioactive tracer for PET imaging)
- What this could lead to
- If successful, this could lead to a new imaging test that helps doctors predict which patients will respond to certain chemotherapy drugs like gemcitabine.
- What could go wrong
- This is a very early, small trial with only 4 participants. It is testing the imaging agent itself, not a treatment, so there is no direct benefit to participants. The tracer may not reliably predict drug response.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
5 people
The number who actually took part.
- Started
-
Mar 2023
- Finished
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May 2023
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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). 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106, United States
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