Imaging blood vessel blockages in sickle cell disease
Positron Emission Tomography (PET) Imaging of Vaso-occlusive Crisis(VOC) in Sickle Cell Disease (SCD).
This study is testing if a special imaging technique can help find pain and inflammation in people with sickle cell disease during painful episodes.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Drugs / interventions | crizanlizumab |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT04925492 on ClinicalTrials.gov |
What this trial studies
This study aims to identify objective biomarkers for vaso-occlusive crises (VOC) in patients with sickle cell disease (SCD) using positron emission tomography (PET). Researchers will utilize the radio tracer 64Cu-LLP2A to quantitatively assess the uptake in areas of pain, hypothesizing that increased uptake correlates with the intensity of pain and systemic inflammation. The findings could enhance patient care by providing real-time insights into VOC occurrences and assist in future drug development targeting SCD complications.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of sickle cell disease who have experienced multiple vaso-occlusive crises in the past year.
Not a fit: Patients with active malignancies, those who are pregnant or breastfeeding, or those undergoing chronic transfusion programs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management of vaso-occlusive crises in sickle cell disease patients.
How similar studies have performed: While the use of PET imaging in this context is novel, previous studies have explored imaging techniques for sickle cell disease, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Pittsburgh, Pennsylvania
- Upmc — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Enrico Novelli, MD, MS — University of Pittsburgh
- Study coordinator: Jude Jonassaint, RN
- Email: jonas@pitt.edu
- Phone: 919-219-7481
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.