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

Primary Purpose

Sickle Cell Disease

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Positron Emission Tomography
Cu-64]-LLP2A
Sponsored by
Enrico M Novelli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Sickle Cell Disease focused on measuring PET MRI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UPMCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Finding Optimal Scan Timing

Scan at Determined Optimal Timepoint

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 15, 2020
Last Updated
March 26, 2023
Sponsor
Enrico M Novelli
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT04925492
Brief Title
PET Imaging of Vaso-Occlusive Crisis (VOC) in SCD
Official Title
Positron Emission Tomography (PET) Imaging of Vaso-occlusive Crisis(VOC) in Sickle Cell Disease (SCD).
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 11, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Enrico M Novelli
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease
Keywords
PET MRI

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Population of adult Sickle Cell patients.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Finding Optimal Scan Timing
Arm Type
Experimental
Arm Description
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.
Arm Title
Scan at Determined Optimal Timepoint
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
PET Scan
Intervention Description
An imaging method that uses radiotracers to view changes in the metabolic process.
Intervention Type
Drug
Intervention Name(s)
Cu-64]-LLP2A
Other Intervention Name(s)
Cu-64]-LLP2A Radiotracer
Intervention Description
A radioactive tracer used in PET imaging.
Primary Outcome Measure Information:
Title
Change in PET tracer uptake in VOC
Description
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.
Title
Association of PET tracer uptake with intensity of pain in VOC
Description
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.
Title
Association of PET tracer uptake with clinical VOC markers
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jude Jonassaint, RN
Phone
919-219-7481
Email
jonas@pitt.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Leticia Candra, BA
Email
LEC117@pitt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enrico Novelli, MD, MS
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jude Jonassaint, RN
Email
jonassaintjc@upmc.edu
First Name & Middle Initial & Last Name & Degree
Leticia Candra, BA
Email
candral@upmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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

Learn more about this trial

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

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