Selpercatinib Pre-RAI in Patients With RET Fusion Thyroid Cancer (RAISE)
NCT06458036 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13
Last updated 2026-04-15
Summary
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
- Differentiated Thyroid Cancer
- Pediatric Cancer
- Cancer
- Cancer, Thyroid
Interventions
- DRUG
-
Selpercatinib Monotherapy
Patients will receive selpercatinib monotherapy for 6 months at the FDA-approved dose.
- RADIATION
-
131I Therapy
Patients will receive 131I therapy after 6 months of selpercatinib.
Sponsors & Collaborators
- collaborator INDUSTRY
-
United States Department of Defense
collaborator FED -
Children's Hospital of Philadelphia
lead OTHER
Principal Investigators
-
Theodore Laetsch, MD · Children's Hospital of Philadelphia
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 2 Years
- Max Age
- 25 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-29
- Primary Completion
- 2030-11-01
- Completion
- 2031-11-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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