Targeted Therapy to Increase RAI Uptake in Metastatic DTC
1 other identifier
observational
32
2 countries
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2021
Longer than P75 for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 16, 2021
CompletedFirst Submitted
Initial submission to the registry
August 23, 2021
CompletedFirst Posted
Study publicly available on registry
August 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2033
November 14, 2025
November 1, 2025
9.6 years
August 23, 2021
November 12, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of patients with increased tumor RAI-avidity after receiving oncogene-specific, targeted therapy
The primary outcome measure is to determine the proportion of patients with differentiated thyroid cancer metastatic to the lungs for whom oncogene-specific, targeted therapy increases tumor RAI-avidity.
up to 5 years
Study Arms (2)
Prospective Cohort
Patients with differentiated thyroid cancer for whom oncogene-specific targeted therapy is planned from commercial supply or as part of a separate therapeutic trial
Data Sharing Cohort
Patients with differentiated thyroid cancer enrolled on other oncogene-specific targeted therapy trials who undergo whole body thyroid scan approximately 28 days after beginning targeted therapy and agree to data sharing
Interventions
Patients will receive oncogene-specific molecularly targeted therapy independently of this protocol either via commercial supply of an FDA approved agent, or as part of a separate therapeutic clinical trial/compassionate use protocol/single patient investigational new drug (IND). During screening, patients will undergo a baseline RAI-whole body scan (WBS) to assess RAI-avidity of their tumor per standard of care. Following approximately 28 days of targeted therapy, the WBS will be repeated to determine whether this therapy is associated with an increase in RAI-avidity of their tumor.
Eligibility Criteria
This study will enroll children and adolescents with differentiated thyroid cancer with pulmonary metastases who are planned to receive oncogene-specific targeted therapy.
You may qualify if:
- Patients with a histologic diagnosis of differentiated thyroid cancer
- 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
- Anatomically evaluable disease on chest Computed tomography (CT) meeting oneo f the following criteria (obtained within 180 days of enrollment):
- multiple (10 or more) noncalcified solid pulmonary nodules visible on CT and/or
- enlarging, discrete pulmonary nodules visible on CT of any number consistent with metastatic disease
- 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:
- Larotrectinib, entrectinib, selitrectinib, and repotrectinib for NTRK fusions
- Selpercatinib and pralsetinib for RET fusions
- Crizotinib, lorlatinib, repotrectinib, and alectinib for ALK fusions
- Dabrafenib and/or trametinib for BRAF V600 mutations
- Oncogene-specific kinase inhibitors other than those specifically delineated above must be approved by the overall study PI prior to enrollment
- \. Patients enrolled on other oncogene-specific targeted therapy trials who undergo whole body thyroid scan approximately 28 days after beginning targeted therapy and agree to data sharing as part of the consent process for that trial.
You may not qualify if:
- 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.
- Females who are pregnant or breastfeeding are excluded due to the potential risks of the RAI used in the WBS to the fetus/neonate.
- Patients who require sedation/general anesthesia to complete a WBS are excluded.
- U.S. Military Personnel are excluded due to the Children's Hospital of Philadelphia (CHOP) Institutional Review Board (IRB) requirements.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
University of California San Francisco
San Francisco, California, 94143, United States
Emory University School of Medicine
Atlanta, Georgia, 30322, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Children's Hospital Westmead
Sydney, New South Wales, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2021
First Posted
August 27, 2021
Study Start
July 16, 2021
Primary Completion (Estimated)
February 1, 2031
Study Completion (Estimated)
February 1, 2033
Last Updated
November 14, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share