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Imaging and Blood Tests for Graft Failure Detection (REVEAL Trial)

Phase 1
Recruiting
Led By Kirsten Williams, MD
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to perform FLT imaging without anesthesia
In morphologic remission prior to HSCT
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24-28 days
Awards & highlights

REVEAL Trial Summary

This trial is testing a new way to see if transplanted bone marrow cells are growing, which could help doctors know if patients need more transplants.

Who is the study for?
This trial is for patients aged 4-70 at high risk of graft failure after bone marrow transplant, such as those with cord blood HSCT or haplo HSCT. Participants must not have had investigational therapies in the last 28 days and should be in remission before HSCT. Pregnant individuals, those with certain allergies, active malignancies outside the hematopoietic system, significant systemic illness, or psychiatric disorders affecting compliance are excluded.Check my eligibility
What is being tested?
The study is testing FLT imaging and TK1 blood measurements to see if they can help determine how well new bone marrow cells are growing post-transplantation. It's looking for better tests to decide if a patient's newly infused bone marrow cells are engrafting successfully or if another transplant might be needed.See study design
What are the potential side effects?
Since this trial involves diagnostic procedures rather than medications, side effects may include discomfort from blood draws and potential risks associated with imaging like exposure to radiation from the FLT scans.

REVEAL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can undergo FLT imaging without needing to be put to sleep.
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My cancer was in remission before my stem cell transplant.
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I can have a special type of imaging test without needing to be sedated.
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I can care for myself but may need occasional help.
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I am diagnosed with a condition that requires a stem cell transplant, which is planned or has occurred.
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My bone marrow transplant didn't work as expected, with low white blood cell counts.

REVEAL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24-28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24-28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
FLT SUV identifies graft failure
Secondary outcome measures
Map subclinical engraftment in alternative donor HSCT
Number of patients with CTCAE version 5 events exceeding grade 3 that are possibly, probably, or definitely attributed to the FLT imaging
Other cytokine and chemokine markers of graft failure
+1 more

REVEAL Trial Design

2Treatment groups
Experimental Treatment
Group I: Nonengrafted cohortExperimental Treatment1 Intervention
Pediatric and adult patients who have not engrafted by day 24 after cord or haplo-identical HSCT will undergo a single FLT PET/CT image within one week to determine if this scan can identify graft failure versus delayed engraftment.
Group II: Cord and haplo imaging cohortExperimental Treatment1 Intervention
For all pediatric and adult patients undergoing cord blood HSCT, FLT PET/CT imaging will occur one day prior to HSCT and on days 9 and 28 after HSCT. For recipients of haplo-HSCT, FLT PET/CT imaging will occur one day prior to HSCT and on days 5 and 28 after HSCT.

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor
455 Previous Clinical Trials
95,777 Total Patients Enrolled
University of MichiganOTHER
1,802 Previous Clinical Trials
6,379,999 Total Patients Enrolled
Emory UniversityOTHER
1,642 Previous Clinical Trials
2,563,975 Total Patients Enrolled
1 Trials studying Graft Failure
19 Patients Enrolled for Graft Failure

Media Library

FLT imaging and TK1 blood measurements Clinical Trial Eligibility Overview. Trial Name: NCT03541889 — Phase 1
Graft Failure Research Study Groups: Cord and haplo imaging cohort, Nonengrafted cohort
Graft Failure Clinical Trial 2023: FLT imaging and TK1 blood measurements Highlights & Side Effects. Trial Name: NCT03541889 — Phase 1
FLT imaging and TK1 blood measurements 2023 Treatment Timeline for Medical Study. Trial Name: NCT03541889 — Phase 1

Frequently Asked Questions

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

Are individuals aged 50 years or younger permitted to participate in this medical research?

"This clinical investigation permits patients aged between 4 and 70 to register as participants. Additionally, there are two separate trials for minors below 18 years old and adults over 65 respectively."

Answered by AI

Is the FDA sanctioning FLT imaging and TK1 blood measurements?

"Our staff at Power assigned a score of 1 for FLT imaging and TK1 blood measurements due to the limited data available regarding their safety and efficacy."

Answered by AI

Is it feasible for me to enroll in this experiment?

"This clinical trial requires the recruitment of 50 individuals between 4 and 70 years old who are at a heightened risk for primary graft failure. To be eligible, these patients must meet certain criteria: they should have undergone or plan to undergo hematopoietic stem cell transplantation (HSCT), demonstrate an ability to perform Fluorodeoxyglucose positron emission tomography (FLT) imaging without sedation or anaesthesia, remain in morphologic remission before HSCT, possess capacity for informed consent, not have received investigational therapies within the past 28 days, exhibit Karnofsky performance score or Lansky performance status higher than"

Answered by AI

Are there any available slots to join the experiment?

"The details on clinicaltrials.gov point to the fact that this trial is actively recruiting volunteers. It was first advertised on February 5th 2021 and has since been reviewed multiple times, with its most recent update occurring May 17th 2022."

Answered by AI

How many participants are being accepted into the experiment?

"To complete this medical trial, fifty compliant individuals are needed. These prospective participants can either attend the University of Michigan in Ann Arbor or Emory University in Atlanta to partake."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
REVEAL Biomarkers of Engraftment After Alternative Donor HSCT
2021. "REVEAL Biomarkers of Engraftment After Alternative Donor HSCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03541889.
~11 spots leftby May 2025
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