RECRUITINGPhase 1INTERVENTIONAL

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

Positron Emission Tomography (PET) Imaging of Vaso-occlusive Crisis(VOC) in Sickle Cell Disease (SCD).

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Have a confirmed diagnosis of SCD (HbSS, SC, S/β-thalassemia, SD, SE, SO) by hemoglobin electrophoresis/High Performance Liquid Chromatography (HPLC) - Aged 18 and above - Ability to understand and provide willing to sign a consent form. - If receiving hydroxyurea or L-glutamine, crizanlizumab, voxelotor or erythropoietin stimulating agents, must have been receiving the drug for at least 12 weeks prior to screening and plan to continue taking the drug at the same dose and schedule during the study - Experienced at least 2 VOCs leading to healthcare visit within the 12 months prior to screening visit as determined by medical history. Who Should NOT Join This Trial: - Active malignancy - Current pregnancy or breast feeding - Participating in a chronic transfusion program (pre-planned series of transfusions for prophylactic purposes) and/or planning on undergoing an exchange transfusion during the duration of the study; episodic transfusion in response to worsened anemia or VOC is permitted - Received active treatment on another investigational trial within 30 days (or 5 half-lives of that agent, whichever is greater) prior to screening visit or plans to participate in another investigational drug trial Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Have a confirmed diagnosis of SCD (HbSS, SC, S/β-thalassemia, SD, SE, SO) by hemoglobin electrophoresis/High Performance Liquid Chromatography (HPLC) * Aged 18 and above * Ability to understand and provide informed consent. * If receiving hydroxyurea or L-glutamine, crizanlizumab, voxelotor or erythropoietin stimulating agents, must have been receiving the drug for at least 12 weeks prior to screening and plan to continue taking the drug at the same dose and schedule during the study * Experienced at least 2 VOCs leading to healthcare visit within the 12 months prior to screening visit as determined by medical history. Exclusion Criteria: * Active malignancy * Current pregnancy or breast feeding * Participating in a chronic transfusion program (pre-planned series of transfusions for prophylactic purposes) and/or planning on undergoing an exchange transfusion during the duration of the study; episodic transfusion in response to worsened anemia or VOC is permitted * Received active treatment on another investigational trial within 30 days (or 5 half-lives of that agent, whichever is greater) prior to screening visit or plans to participate in another investigational drug trial

Treatments Being Tested

RADIATION

Positron Emission Tomography

An imaging method that uses radiotracers to view changes in the metabolic process.

DRUG

Cu-64]-LLP2A

A radioactive tracer used in PET imaging.

Locations (1)

UPMC

Pittsburgh, Pennsylvania, United States