Actively Recruiting
Selpercatinib to Enhance Radioactive Iodine Therapy in Children, Adolescents, and Young Adults With RET Fusion Differentiated Thyroid Cancer
Led by Children's Hospital of Philadelphia · Updated on 2026-04-15
13
Participants Needed
4
Research Sites
52 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital of Philadelphia
Lead Sponsor
E
Eli Lilly and Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
Papillary thyroid cancer (PTC) is the most common type of differentiated thyroid cancer (DTC). Researchers are studying a new approach combining the drug selpercatinib followed by radioactive iodine (131I) therapy for patients with RET fusion differentiated thyroid cancer. This open-label, non-randomized Phase II study aims to evaluate how well this combination works and its safety, focusing on lung response after treatment. The study is exempt from FDA Investigational New Drug requirements. Participants will first receive selpercatinib alone for six months at the FDA-approved dose. After this period, they will undergo radioactive iodine therapy while continuing selpercatinib for five more days. Then, they will enter a monitoring period without treatment. Patients whose disease worsens during selpercatinib treatment will switch earlier to radioactive iodine therapy and stop selpercatinib. Throughout the study, participants will be monitored for lung and overall tumor response, biochemical changes, and any side effects for up to 18 months and beyond. Researchers will also track survival without disease progression for five years after treatment. Assessments include imaging scans, laboratory tests, and safety evaluations. The total study duration includes treatment and follow-up periods to observe long-term outcomes.
CONDITIONS
Brief Title
Selpercatinib Pre-RAI in Patients With RET Fusion Thyroid Cancer (RAISE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 2 and 25 years, inclusive
- Histologic diagnosis of differentiated thyroid cancer after thyroidectomy and adequate local therapy for metastatic neck disease
- Anatomically evaluable lung disease on chest CT with either multiple (>10) noncalcified solid nodules or enlarging discrete pulmonary nodules
- Presence of activating RET gene alteration (fusion or mutation) confirmed by certified laboratory without known resistance mutations
- Lansky or Karnofsky performance status above 50%
- Adequate bone marrow, renal, and liver function as defined by specific laboratory criteria
- Normal serum potassium, calcium, and magnesium levels (supplements allowed)
- Agreement to use highly effective contraception during treatment and for 6 months after
- Negative pregnancy test for women of childbearing potential before and during treatment
You will not qualify if you...
- Prior systemic therapy for thyroid cancer including RET inhibitors (prior radioactive iodine allowed)
- Pregnant or breastfeeding females
- Use of strong CYP3A4 inducers or inhibitors within 14 days before and during study
- Active significant cardiovascular disease, recent myocardial infarction, or prolonged QTc interval (>470 msec)
- Active malabsorption syndrome or conditions affecting drug absorption
- Use of medications known to cause QTc prolongation
- Active bleeding or significant risk of hemorrhage
- Uncontrolled hypertension above specified limits (140/90 in adults or >95th percentile for children)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 months plus post-therapy period
Participants receive selpercatinib monotherapy for 6 months followed by 131I therapy. Selpercatinib continues for 5 days after 131I therapy, then participants enter a wait and see period off treatment.
Visits during 6 months of selpercatinib treatment and additional visits around 131I therapy
Duration - Up to 18 months after treatment start
Participants are monitored for treatment response and safety for up to 18 months after starting treatment, including evaluation of pulmonary structural response and adverse events.
Scheduled follow-up visits for assessments
Trial Site Locations
Total: 4 locations
1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
2
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
3
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Not Yet Recruiting
4
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Not Yet Recruiting
Research Team
M
Meghan Donnelly, MPH
J
James Robinson
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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