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PET Imaging for Sickle Cell Crisis

Phase 1

Recruiting

Led By Enrico Novelli, MD, MS

Research Sponsored by Enrico M Novelli

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Have a confirmed diagnosis of SCD (HbSS, SC, S/β-thalassemia, SD, SE, SO) by hemoglobin electrophoresis/High Performance Liquid Chromatography (HPLC)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to five years from first assessment depending on when voc occurs.

Awards & highlights

Study Summary

This trialwill study if PET imaging can detect VOC in SCD patients, allowing us to better understand and treat VOCs in the future.

Who is the study for?

This trial is for adults with Sickle Cell Disease who've had at least 2 blood vessel blockage crises in the past year. They must be on stable doses of certain medications like hydroxyurea for 12 weeks before and during the study. People with cancer, pregnant or breastfeeding women, and those on regular blood transfusions or another drug trial recently can't join.Check my eligibility

What is being tested?

Researchers are testing a new way to see blood vessel blockages using PET scans and a tracer called Cu-64]-LLP2A in people with Sickle Cell Disease. This could improve patient care by predicting these painful crises and aiding future drug development.See study design

What are the potential side effects?

The side effects related to PET imaging may include discomfort at the injection site, allergic reactions to the tracer, exposure to radiation, and anxiety from being in a confined space during scanning.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been on my current medication for sickle cell disease for at least 12 weeks and plan to continue it during the study.

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I have been diagnosed with Sickle Cell Disease through specific blood tests.

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I understand the study and agree to participate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to five years from first assessment depending on when voc occurs.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to five years from first assessment depending on when voc occurs.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to five years from first assessment depending on when voc occurs. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Association of PET tracer uptake with clinical VOC markers

Association of PET tracer uptake with intensity of pain in VOC

Change in PET tracer uptake in VOC

Trial Design

2Treatment groups

Experimental Treatment

Group I: Scan at Determined Optimal TimepointExperimental Treatment2 Interventions

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.

Group II: Finding Optimal Scan TimingExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography

2008

Completed Phase 2

~2240

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Pittsburgh FoundationOTHER

5 Previous Clinical Trials

309 Total Patients Enrolled

Enrico M NovelliLead Sponsor

1 Previous Clinical Trials

30 Total Patients Enrolled

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,835 Previous Clinical Trials

47,310,650 Total Patients Enrolled

Media Library

Scan at Determined Optimal Timepoint Clinical Trial Eligibility Overview. Trial Name: NCT04925492 — Phase 1

Sickle Cell Disease Research Study Groups: Scan at Determined Optimal Timepoint, Finding Optimal Scan Timing

Sickle Cell Disease Clinical Trial 2023: Scan at Determined Optimal Timepoint Highlights & Side Effects. Trial Name: NCT04925492 — Phase 1

Scan at Determined Optimal Timepoint 2023 Treatment Timeline for Medical Study. Trial Name: NCT04925492 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any recruitment opportunities for individuals to partake in this research?

"Clinicaltrials.gov confirms the continued recruitment for this trial which was inaugurated on November 11th 2022 and recently modified on December 2nd 2022."

Answered by AI

How many people are eligible to participate in this clinical trial?

"Affirmative. Based on information hosted on clinicaltrials.gov, this medical study is still recruiting participants as of December 2nd 2022 when it was last updated. The original post date for the trial was November 11th 2020 and only 20 patients need to be recruited at one site."

Answered by AI

Has the FDA provided authorization for Scan at Determined Optimal Timepoint?

"Taking into consideration the Phase 1 status of this drug, Power has attributed a score of 1 to Scan at Determined Optimal Timepoint's safety profile. This rating is based on limited evidence that supports both efficacy and security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Enrico M Novelli 2022. "PET Imaging of Vaso-Occlusive Crisis (VOC) in SCD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04925492.

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