Recruiting

Targeted Therapy

Sponsor:

Children's Hospital of Philadelphia

Code:

NCT05024929

Conditions

Papillary Thyroid Cancer

Pediatric Cancer

Differentiated Thyroid Cancer

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Whole body scan

Study Details

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.

Conditions

Papillary Thyroid Cancer

Pediatric Cancer

Differentiated Thyroid Cancer

Study ID

NCT05024929

Start date

Jul 16, 2021

Status verified date

Nov, 2025

Completion date

Feb 1, 2033

Anticipated

Primary completion date

Feb 1, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

32 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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.

Primary outcome measure

  • Proportion of patients with increased tumor RAI-avidity after receiving oncogene-specific, targeted therapy [ Time Frame: up to 5 years ]

Central Contacts and Locations

Central contacts

Locations

University of California San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Emory University School of Medicine

Recruiting

Atlanta, Georgia, United States, 30322

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Principal Investigator:

Junne Kamihara, MD

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Principal Investigator:

Theodore Laetsch, MD

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Steven Waguespack, MD

Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Priya Mahajan, MD

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Principal Investigator:

Tyler Ketterl, MD, MS

More Information

Sponsor

Children's Hospital of Philadelphia

Last update posted

Nov 14, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Hospital of Philadelphia on 2025-11-14.