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Selpercatinib for RET Fusion Thyroid Cancer (RAISE) Study

This study is looking at a new way to treat differentiated thyroid cancer (DTC) in children and young adults aged 2 to 25. If you have DTC with a specific genetic change called a RET fusion, you might be able to join. The study will give you a drug called selpercatinib for 6 months, followed by radioactive iodine (131I) therapy. Researchers want to see if this combination helps shrink tumors in the lungs and if the radioactive iodine works better after selpercatinib. They will check your progress for up to 5 years. The study plans to enroll 13 participants.

Study design
This is an open-label, non-randomized study. It will involve 13 participants.
What's involved
You would receive selpercatinib for 6 months, followed by 131I therapy. Your response will be measured at 6 months, 18 months, and 5 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years after treatment to see how well the treatment works and if the disease progresses.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06458036

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

Recruiting
PHASE2Ages 2–25InterventionalTreatment
Children's Hospital of Philadelphia
~13 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:Selpercatinib Monotherapy131I Therapy

At a glance

Recruiting sites
3 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of patients with complete overall, pulmonary, structural, and biochemical response.
Measured over 18 months
+3 more outcomes measured

Conditions

Differentiated Thyroid Cancer
Pediatric Cancer
Cancer
Cancer, Thyroid

Explore related trials

Differentiated Thyroid Gland CarcinomaProto-Oncogene Tyrosine-Protein Kinase Receptor Ret

Where it's being run

5 sites across 5 states
California1
Pennsylvania1
Tennessee1
Texas1
Washington1

Study leadership

  • Theodore Laetsch, MD · PRINCIPAL_INVESTIGATOR · Children's Hospital of Philadelphia

Who to contact

Meghan Donnelly, MPH
[email protected]
267-426-9343
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Peripheral absolute neutrophil count (ANC) ≥1500/µL
Platelet count ≥ 100,000/µL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
Hemoglobin ≥ 9.0 g/dL at baseline (may receive Red Blood Cell transfusions).
Bilirubin (sum of conjugated + unconjugated) \< / = 1.5 x upper limit of normal (ULN) for age. Except participants with a documented history of Gilbert syndrome who must have a total bilirubin level of \<3.0X ULN
Alanine aminotransferase (ALT) \<2.5X ULN OR \<5x ULN if the liver has tumor involvement. For the purpose of this study, the ULN for ALT is 45 U/L.
Serum albumin ≥ 2 g/dL 7. Patient must have normal serum potassium, calcium, and magnesium levels (may be receiving supplements) 8. Men with partners of childbearing potential or women of childbearing potential must agree to use a highly effective contraceptive method during treatment with study drug and for 6 months following the last dose of study drug. Selpercatinib could impair fertility in males and females. Advise women not to breastfeed during treatment with selpercatinib and for 1 week following the final dose 9. Women of childbearing potential must have a negative pregnancy test (serum or urine, consistent with local regulations) documented within 24 hours prior to treatment with study drug and at least monthly while on study treatment

What this trial measures

  • Number of patients with complete overall, pulmonary, structural, and biochemical response.18 months

    Determine the overall, pulmonary, structural, and biochemical response rate to selpercatinib in patients with RET fusion differentiated thyroid cancer treated with 6 months of selpercatinib prior to 131I therapy

  • Number of patients who survive without progression of disease after 5 years following protocol treatment.5 years

    Determine the progression free survival to the combination of selpercatinib followed 6 months later 131I therapy from the initiation of selpercatinib therapy

  • Proportion of all patients enrolled who show increased radioactive iodine avidity at 6 months following selpercatinib monotherapy.6 months

    Determine the proportion of patients for whom oncogene-specific, targeted therapy increases tumor RAI-avidity.

  • The incidence of adverse events and dose limiting toxicity with the combination of selpercatinib and 131I therapy, graded according to CTCAE v5.12 months

    Determine the safety of the combination of selpercatinib given for 6-months followed by 131I therapy in patients with RET fusion differentiated thyroid cancer