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Evaluating Myelodysplastic Syndrome Risks in NET Patients Planned for Peptide Radionuclide Therapy (MDS & PRRT Trial)

N/A
Waitlist Available
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This is a prospective observational study which aims to identify individuals predisposed to developing myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) could improve patient outcomes in different ways. First, it will enable improved patient selection for PRRT where alternative treatment options are available. Second, understanding the final pathway and how it is modulated by PRRT could allow the design of strategies to halt this process. Third, while it is unknown whether the development of MDS and AML is a late effect of radiopharmaceuticals in general or it is confined to cancer populations or specific radioisotopes will need to be confirmed. Finally, understanding this devastating complication is expected to be the cornerstone towards advancing radiopharmaceuticals' role in the adjuvant setting.

Eligible Conditions
  • Myelodysplastic Syndrome
  • Acute Myeloid Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Identify individuals predisposed to developing MDS/AML to improve patient selection for PRRT where alternative treatment options are available.
Secondary study objectives
Assessment of Variant Allele Frequencies Post-PRRT
Detection of Genetic Mutations in the Blood Post-PRRT
Identification of Clonal Mutations Conferring Increased Risk of MDS/AML Post-PRRT
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Previous PRRTExperimental Treatment1 Intervention
Patients who have received PRRT within the last 4 years. There are no baseline levels available for cohort A patients. Sample size: 20.
Group II: Post PRRT Diagnosed with t-MN (MDS or AML)Experimental Treatment1 Intervention
Patients who have t-MN (MDS or AML). Sample size: 5.
Group III: Planned for PRRTExperimental Treatment2 Interventions
Patients who are scheduled to start PRRT in the next 3 months. Pre-PRRT clonal expansion status will only be available form this cohort. These patients will provide a comprehensive record of development of CH from exposure to PRRT. Sample size: 20.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blood collection
2013
Completed Phase 1
~39500

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,531 Previous Clinical Trials
504,277 Total Patients Enrolled
~30 spots leftby Apr 2028
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