Evaluating risks of myelodysplastic syndrome in patients receiving peptide radionuclide therapy
Evaluating Myelodysplastic Syndrome Risks in NET Patients Planned for Peptide Radionuclide Therapy
This study is trying to find out if certain patients who receive a specific cancer treatment are at risk of developing blood disorders like myelodysplastic syndrome and leukemia, to make the treatment safer for everyone.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 45 (estimated) |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06510868 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify patients at risk of developing myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) following peptide receptor radionuclide therapy (PRRT) for neuroendocrine tumors. By analyzing genetic changes and patient responses, the study seeks to improve patient selection for PRRT and develop strategies to mitigate the risk of these serious conditions. The research will also explore whether the development of MDS and AML is linked to specific radioisotopes or is a broader effect of radiopharmaceuticals. Ultimately, the findings could enhance the safety and efficacy of PRRT in treating cancer.
Who should consider this trial
Good fit: Ideal candidates include patients with neuroendocrine tumors who are either planning to undergo PRRT or have recently completed it.
Not a fit: Patients who are unwilling to provide blood samples or those with a life expectancy of less than six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better patient selection for PRRT and strategies to prevent the development of MDS and AML.
How similar studies have performed: While the study explores a critical area of research, the specific approach of identifying genetic predispositions in the context of PRRT is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Toronto, Ontario
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Rebecca Wong
- Email: rebecca.wong@uhn.ca
- Phone: 416-946-4501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.