A Phase 1 interventional study of Positron Emission Tomography and Cu-64]-LLP2A in Sickle Cell Disease, sponsored by Enrico Novelli. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Enrico Novelli · Phase 1, Interventional, and Screening
The purpose of this study is to find objective biomarkers of vaso-occlusion (blood vessel blockage) in people with SCD. Using information from earlier studies and work being done, researchers have developed a strategy to image VOC, using positron emission tomography (PET).
The ability to see and measure VOC in SCD patients can help patient care, by showing when and how a VOC is occurring or going to occur. Studying this method will also help in future drug research, as it will allow researchers to deliver promising new medications that target hyper-adhesion and sickling in people with SCD.
The purpose of this study is to find objective biomarkers of vaso-occlusion (blood vessel blockage) in people with Sickle Cell Disease(SCD). Using information from earlier studies, and work being done at Washington University, a strategy to image vaso-occulusive crisis (VOC) has been developed, using positron emission tomography (PET) for anatomical localization only. 64Cu-LLP2A is the radio tracer used for the study.
Aim: To develop quantitative PET imaging of VOC in patients with SCD. The researchers hypothesize that the radio tracer 64Cu-LLP2A uptake increases proportionally to the intensity of pain in patients with VOC, compared to baseline values. This increase in uptake will be assessed focally in areas of pain as well as globally to reflect heightened systemic inflammation.
Primary and secondary study endpoint: The overarching hypothesis of this study is that PET tracer uptake of intensity of 64Cu-LLP2A is a real time, quantitative measure of hyper adhesion in VOC.
1,103 studies on the registry are indexed under Anemia, Sickle Cell; 235 are open to participants now.
This study's enrollment of 15 is below the median of 40 across 750 interventional studies indexed under Anemia, Sickle Cell.
Browse Anemia, Sickle Cell studies →Enrico Novelli is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Group A will receive two PET scans after the radiotracer injection to learn the best timing of the scan for the rest of the people in the study during participant's baseline state. Participants will receive another injection of the radiotracer during a sickle cell crisis and have one PET scan. Receive an optional injection and perform another PET scan 12 months after your sickle cell crisis if there were technical problems the previous scans.
Radiation: Positron Emission Tomography · Drug: Cu-64]-LLP2A
Group B participants will receive an injection of the radiotracer and undergo only one PET scan during a baseline state. Participants will receive another injection of the radiotracer during a sickle cell crisis and have one PET scan. Receive an optional injection and perform another PET scan 12 months after your sickle cell crisis if there were technical problems the previous scans.
Radiation: Positron Emission Tomography · Drug: Cu-64]-LLP2A
An imaging method that uses radiotracers to view changes in the metabolic process.
Also known as: PET Scan
A radioactive tracer used in PET imaging.
Also known as: Cu-64]-LLP2A Radiotracer
Change in PET tracer uptake in VOC
Intensity of PET tracer uptake in VOC will be measured and compared to uptake at baseline in predefined regions of interest and over the whole body
Time frame: Up to five years from first assessment depending on when VOC occurs.
Association of PET tracer uptake with intensity of pain in VOC
Intensity of PET tracer uptake will be compared to intensity of pain by Visual Analog Score (scored from 0-10, with 0 meaning no pain, and 10 meaning the most pain) and pain characteristic assessed by the Painimation assessment tool in specific anatomical areas in the patients during a sickle cell vaso-occlusive event.
Time frame: 2 hours during an assessment while in VOC.
Association of PET tracer uptake with clinical VOC markers
Measure of PET tracer uptake will be compared with clinical markers of vaso-occlusive events including length of stay and hematologic markers of hemolysis.
Time frame: Up to the length of a hospital visit for treatment of VOC. On average, about 5 days.
Plan to share: No — Information and stored samples may be shared without identifiers with other researchers in the future. These researchers will not receive identifiable information linking data or sample back to individual participants. This access may be granted for the advancement of scientific knowledge. Any future sharing will be conducted under an approved sharing agreement
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Enrico Novelli