Actively Recruiting
Selpercatinib Pre-RAI in Patients With RET Fusion Thyroid Cancer (RAISE)
Led by Children's Hospital of Philadelphia · Updated on 2026-04-15
13
Participants Needed
4
Research Sites
378 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 form of differentiated thyroid cancer (DTC). The traditional first line treatment for patients with advanced DTC after surgical resection is radioactive iodine (RAI) therapy. However, less than a quarter of patients with lung metastases will achieve a complete response to RAI therapy, and this therapy carries the risk of pulmonary fibrosis and an increasingly recognized risk of secondary malignancies.
CONDITIONS
Official Title
Selpercatinib Pre-RAI in Patients With RET Fusion Thyroid Cancer (RAISE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 2 to 25 years, inclusive
- Diagnosed with differentiated thyroid cancer after thyroid surgery and adequate local treatment for metastatic neck disease
- Multiple (>10) or enlarging lung nodules visible on chest CT scan within 90 days of enrollment
- Confirmed activating RET gene fusion or mutation from a certified laboratory
- Lansky or Karnofsky performance status greater than 50%
- Adequate bone marrow function: ANC ≥1500/µL, platelet count ≥100,000/µL without recent transfusions, hemoglobin ≥9.0 g/dL
- Adequate kidney function: creatinine clearance or GFR ≥70 mL/min/1.73 m2 or age/gender-based maximum serum creatinine
- Adequate liver function: bilirubin ≤1.5 x ULN (or ≤3.0 x ULN with Gilbert syndrome), ALT <2.5 x ULN (or <5 x ULN if liver tumor involvement), serum albumin ≥2 g/dL
- Normal potassium, calcium, and magnesium levels (supplements allowed)
- Agreement to use highly effective contraception during treatment and for 6 months after last dose if of childbearing potential
- Negative pregnancy test within 24 hours before treatment and monthly during study for women of childbearing potential
You will not qualify if you...
- Previous systemic therapy for thyroid cancer, including RET inhibitors; prior 131I allowed
- Currently pregnant or breastfeeding females
- Use of strong CYP3A4 inducers or inhibitors within 14 days prior to and during study treatment
- Clinically significant active cardiovascular disease, recent myocardial infarction within 6 months, Torsades de pointes, or QTcF >470 msec
- Active malabsorption syndrome or conditions affecting drug absorption
- Use of medications known to cause QTc prolongation
- Active bleeding or high risk of hemorrhage
- Uncontrolled hypertension (blood pressure >140/90 in adults or >95th percentile for children by height and gender) despite antihypertensive treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
J
James Robinson
CONTACT
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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