Targeted Therapy to Increase RAI Uptake in Metastatic DTC

Last updated: June 16, 2025
Sponsor: Children's Hospital of Philadelphia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neuroblastoma

Retinoblastoma

Treatment

Whole body scan

Clinical Study ID

NCT05024929
21-018612
  • All Genders

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 Criteria

Inclusion

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):

  4. multiple (10 or more) noncalcified solid pulmonary nodules visible on CT and/or

  5. enlarging, discrete pulmonary nodules visible on CT of any number consistent with metastatic disease

  6. 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:

  7. Larotrectinib, entrectinib, selitrectinib, and repotrectinib for NTRK fusions

  8. Selpercatinib and pralsetinib for RET fusions

  9. Crizotinib, lorlatinib, repotrectinib, and alectinib for ALK fusions

  10. Dabrafenib and/or trametinib for BRAF V600 mutations

  11. 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

Total Participants: 32
Treatment Group(s): 1
Primary Treatment: Whole body scan
Phase:
Study Start date:
July 16, 2021
Estimated Completion Date:
February 01, 2033

Study 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.

Connect with a study center

  • Children's Hospital Westmead

    Sydney, New South Wales
    Australia

    Active - Recruiting

  • University of California San Francisco

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Emory University School of Medicine

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • St. Jude Children's Research Hospital

    Memphis, Tennessee 38105
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Texas Children's Hospital

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Active - Recruiting

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