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Targeted Therapy to Increase RAI Uptake in Metastatic DTC | Clinical Trials | Clareo Health

RECRUITING

Targeted Therapy to Increase RAI Uptake in Metastatic DTC

Targeted Therapy to Increase RAI Uptake in Patients With Metastatic Differentiated Thyroid Cancer

NCT05024929•Children's Hospital of Philadelphia

Summary

Papillary thyroid cancer (PTC) is a common type of differentiated thyroid cancer (DTC) in children and represents the second most common cancer in adolescent females. Recently targeted drugs that block many of the genetic drivers of DTC have become available. While Investigators know that these drugs shrink DTC tumors in many cases, the impact on radioactive iodine (RAI) avidity has not been systematically studied.

Detailed Description

This is an observational cohort study that will enroll patients with DTC metastatic to the lungs who will receive oncogene-specific targeted therapy as part of routine clinical care or a separate therapeutic clinical trial. After approximately 4 weeks of therapy, patients will have a whole body scan to determine the change in RAI-avidity of their tumor from baseline. Subsequent therapy will be at the discretion of the treating physician or according to the therapeutic trial on which the patient is enrolled.

Eligibility

Age

0 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients with a histologic diagnosis of differentiated thyroid cancer
•2. Presence of an neurotrophic tyrosine kinase receptors (NTRK)-fusion, RET-fusion, anaplastic lymphoma kinase (ALK)-fusion, BRAF V600 mutation, BRAF-fusion or other targetable alteration identified in a Clinical Laboratory Improvement Amendments/College of American Pathologists (CLIA/CAP) laboratory
•3. Anatomically evaluable disease on chest Computed tomography (CT) meeting oneo f the following criteria (obtained within 180 days of enrollment):
•1. multiple (10 or more) noncalcified solid pulmonary nodules visible on CT and/or
•2. enlarging, discrete pulmonary nodules visible on CT of any number consistent with metastatic disease
•4. Patients for whom systemic therapy with an oncogene-specific kinase inhibitor is planned from commercial supply or as part of a separate therapeutic clinical trial (that does not include data sharing with this protocol)/compassionate access protocol/single patient investigational new drug (IND). Such agents include, but are not limited to:
•1. Larotrectinib, entrectinib, selitrectinib, and repotrectinib for NTRK fusions
•2. Selpercatinib and pralsetinib for RET fusions
•3. Crizotinib, lorlatinib, repotrectinib, and alectinib for ALK fusions
•4. Dabrafenib and/or trametinib for BRAF V600 mutations
+2 more criteria

Exclusion Criteria

•1. No prior oncogene-specific targeted therapy allowed. However, patients may enroll within 4 weeks of starting oncogene-specific therapy if a pre-therapy WBS is available. Prior therapy with non-oncogene specific multi-thyrosine kinase inhibitors (such as sorafenib, lenvatinib, and/or cabozantanib) is allowed.
•2. Females who are pregnant or breastfeeding are excluded due to the potential risks of the RAI used in the WBS to the fetus/neonate.
•3. Patients who require sedation/general anesthesia to complete a WBS are excluded.
•4. U.S. Military Personnel are excluded due to the Children's Hospital of Philadelphia (CHOP) Institutional Review Board (IRB) requirements.

Locations (9)

University of California San Francisco

San Francisco, California, United States

Emory University School of Medicine

Atlanta, Georgia, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

Texas Children's Hospital

Houston, Texas, United States

Seattle Children's Hospital

Seattle, Washington, United States

Children's Hospital Westmead

Sydney, New South Wales, Australia

Key Dates

Start Date

July 16, 2021

Primary Completion Date

February 1, 2031

Completion Date

February 1, 2033

Last Updated

November 14, 2025

Enrollment

ESTIMATED participants

Conditions

Papillary Thyroid CancerPediatric CancerDifferentiated Thyroid Cancer

Interventions

Whole body scan

PROCEDURE

Contacts

Meghan T Donnelly

CONTACT

2674269343 donnellymt@chop.edu

James Robinson

CONTACT

215-590-2053 robinsonj9@chop.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Targeted Therapy to Increase RAI Uptake in Metastatic DTC

Inclusion Criteria

Exclusion Criteria

The Clinical Outcomes and Prediction of Thermal Ablation for Low-risk Papillary Thyroid Carcinoma

F-18 Tetrafluoroborate PET/CT in Differentiated Thyroid Cancer

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