Recruiting

Peptide Radionuclide Therapy

Sponsor:

University Health Network, Toronto

Code:

NCT06510868

Conditions

Myelodysplastic Syndrome

Acute Myeloid Leukemia

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Peptide receptor radionuclide therapy (PRRT)

Blood collection

Study Details

Brief 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.

Conditions

Myelodysplastic Syndrome

Acute Myeloid Leukemia

Study ID

NCT06510868

Start date

Aug 1, 2024

Status verified date

Mar, 2026

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Apr 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • ECOG 0-3
  • Life expectancy > 6 months
  • Informed consent and willingness to undergoing serial genetic panel CHIP testing.
  • Cohort Specific criteria

1. Cohort A: PRRT completed within 5 years of enrolment
2. Cohort B: PRRT planned to commence within 4 months of enrolment
3. Cohort C: diagnosis of MDS or AML following prior PRRT.

Exclusion Criteria:
  • Unwillingness to provide blood sample and follow up as per protocol

Study Design

Enrollment

45 participants

Anticipated

Interventions and Outcome Measures

Arms

Previous PRRT

Patients who have received PRRT within the last 4 years. There are no baseline levels available for cohort A patients. Sample size: 20.

Planned for PRRT

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.

Post PRRT Diagnosed with t-MN (MDS or AML)

Patients who have t-MN (MDS or AML). Sample size: 5.

Interventions

Peptide receptor radionuclide therapy (PRRT)

Specialized type of radionuclide therapy used to treat neuroendocrine tumors.

Blood collection

Patients will have approximately 5 ml of blood drawn 6,12,24,36,48, 60 months and at the time of MDS/AML diagnosis on follow up. Genomic DNA will be extracted from serum sample using the Qiagen QIAamp DNA Mini Kit. Single-molecule molecular inversion probes (smMIPs) will be used to detect mutations. Single nucleotide variants (SNVs), short insertions and deletions (indels), and mutated myeloid genes will be captured (e.g PPM1D, DNMT3A, TET2, TP53).

Primary outcome measure

  • Identify individuals predisposed to developing MDS/AML to improve patient selection for PRRT where alternative treatment options are available. [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Rebecca Wong

416-946-4501rebecca.wong@uhn.ca

Locations

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Rebecca Wong, MD

416-946-4501rebecca.wong@rmp.uhn.on.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-03-05.