PET Imaging of Vaso-Occlusive Crisis (VOC) in SCD

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Enrico Novelli
Study ID
NCT04925492
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Positron Emission Tomography — RADIATION
    An imaging method that uses radiotracers to view changes in the metabolic process.
  • Cu-64]-LLP2A — DRUG
    A radioactive tracer used in PET imaging.

Study Details

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.

Key Dates

Start date
Nov 11, 2022
Status verified
May 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SCREENING

Arms

  • Experimental: Finding Optimal Scan Timing
    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.
  • Experimental: Scan at Determined Optimal Timepoint
    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.

Primary Outcome Measure

Change in PET tracer uptake in VOC [ Time Frame: Up to five years from first assessment depending on when VOC occurs. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UPMCPittsburghPennsylvania15213
Jude Jonassaint, RN
[email protected]
Leticia Candra, BA
[email protected]

Find similar trials in Pittsburgh, PA

By condition
Sickle cell disease
By research site
UPMC· Pittsburgh, PA

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