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

Sickle Cell Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04925492
• Other study ID #: STUDY20020135
• Secondary ID: R01HL154629
• Status: Recruiting
• Phase: Phase 1
• Start date: November 11, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2024
• Source: University of Pittsburgh
• Contact: Jude Jonassaint, RN
• Phone: 919-219-7481
• Email: jonas[@]pitt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have a confirmed diagnosis of SCD (HbSS, SC, S/ß-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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

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

Country	Name	City	State
United States	UPMC	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Enrico Novelli	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to five years from first assessment depending on when VOC occurs.
Primary	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.	2 hours during an assessment while in VOC.
Primary	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.	Up to the length of a hospital visit for treatment of VOC. On average, about 5 days.