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

Palo Alto (17 mi)

Age: Any Age

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Recruiting

Sponsor: University Health Network, Toronto

Stay on your current meds

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Treatment Details

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.