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Clinical Trials in Australia / NCT05024929
Recruiting Observational

Targeted Therapy to Increase RAI Uptake in Metastatic DTC

NCT05024929 · tracked via the Priya Life Science Australia tracker
Phase
Observational
Started
2021-07-16
Last updated
2025-11-14

Condition(s) studied

Papillary Thyroid CancerPediatric CancerDifferentiated Thyroid Cancer

Investigational drug(s) / intervention(s)

Whole body scan

Whole body scan: 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.

Study 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.

Eligibility

Sex
ALL
Min age
0 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria (Prospective Cohort): 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 5. Oncogene-specific kinase inhibitors other than those specifically delineated above must be approved by the overall study PI prior to enrollment Inclusion Criteria (Data Sharing Cohort): 1\. 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. Exclusion Criteria (All Cohorts): 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.

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
University of California San Francisco San Francisco California Recruiting
Emory University School of Medicine Atlanta Georgia Recruiting
Boston Children's Hospital Boston Massachusetts Recruiting
Children's Hospital of Philadelphia Philadelphia Pennsylvania Recruiting
St. Jude Children's Research Hospital Memphis Tennessee Recruiting
MD Anderson Cancer Center Houston Texas Recruiting
Texas Children's Hospital Houston Texas Recruiting
Seattle Children's Hospital Seattle Washington Recruiting
Children's Hospital Westmead Sydney New South Wales Recruiting

More Children's Hospital of Philadelphia trials in Australia

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05024929 on ClinicalTrials.gov ↗ ← All trials in Australia