NCT06458036

Selpercatinib Pre-RAI in Patients With RET Fusion Thyroid Cancer (RAISE)

Selpercatinib to Enhance RAI Avidity in Children, Adolescents, and Young Adults With Newly Diagnosed Differentiated Thyroid Cancers Harboring RET Fusions

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (estimated)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 2 Years – 25 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This will be an open label, non-randomized study to evaluate the efficacy and safety of the combination of selpercatinib followed by 131I therapy for patients with RET fusion differentiated thyroid cancer. The primary Phase II objective will be to evaluate the pulmonary structural response rate at 18 months to the combination of selpercatinib given for 6-months followed by 131I therapy. This is exempt from Investigational New Drug requirements per the FDA.

Conditions

• Differentiated Thyroid Cancer
• Pediatric Cancer
• Cancer
• Cancer, Thyroid

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-07-29
• Primary completion: 2030-11-01
• Completion: 2031-11-01
• First posted: 2024-06-13
• Last updated: 2026-04-15

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study