Targeted therapy to improve radioactive iodine uptake in metastatic thyroid cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational cohort study focuses on patients with differentiated thyroid cancer (DTC) that has metastasized to the lungs. Participants will receive oncogene-specific targeted therapy as part of their routine clinical care or a separate therapeutic clinical trial. After approximately four weeks of treatment, patients will undergo a whole body scan to assess changes in the radioactive iodine (RAI) avidity of their tumors compared to baseline measurements. The subsequent treatment plan will be determined by the treating physician or based on the therapeutic trial protocol.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of California San Francisco
  San Francisco, California, United States Recruiting
• Emory University School of Medicine
  Atlanta, Georgia, United States Recruiting
• Boston Children's Hospital
  Boston, Massachusetts, United States Recruiting
• Children's Hospital of Philadelphia
  Philadelphia, Pennsylvania, United States Recruiting
• St. Jude Children's Research Hospital
  Memphis, Tennessee, United States Recruiting
• MD Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: Meghan T Donnelly
• Email: donnellymt@chop.edu
• Phone: 2674269343

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.