Targeted Therapy to Increase RAI Uptake in Patients with Metastatic Differentiated Thyroid Cancer
This study evaluates how targeted therapy affects radioiodine (RAI) absorption in patients with metastatic differentiated thyroid cancer.
Inclusion Criteria
- PROSPECTIVE COHORT: * Patients with a histologic diagnosis of differentiated thyroid cancer * Presence of an NTRK-fusion, RET-fusion, ALK-fusion, BRAF V600 mutation, or other targetable alteration identified in a CLIA/CAP laboratory. Targetable alterations other than those specifically delineated above must be approved by the overall study PI prior to enrollment * Anatomically evaluable disease on chest CT meeting one of the following criteria (obtained within 180 days of enrollment): ** multiple (>= 10) 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 IND. Such agents include, but are not limited to: ** Larotrectinib, entrectinib, and repotrectinib for NTRK fusions ** Selpercatinib and pralsetinib for RET fusions ** Crizotinib, lorlatinib, entrectinib, repotrectinib, and alectinib for ALK fusions ** Dabrafenib with or without 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 DATA SHARTING COHORT: * 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
- * 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 cabozantinib) 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 CHOP IRB requirements
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05024929.
Locations matching your search criteria
United States
California
San Francisco
Georgia
Atlanta
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Boston
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Philadelphia
Tennessee
Memphis
Texas
Houston
Washington
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PRIMARY OBJECTIVE:
I. Determine the proportion of children and adolescents with differentiated thyroid cancer metastatic to the lungs for whom oncogene-specific, targeted therapy increases tumor RAI-avidity.
OUTLINE: This is an observational study. Patients are assigned to 1 of 2 cohorts.
PROSPECTIVE COHORT: Patients receive Thyrogen intramuscularly and undergo whole body scan on study. Patients also have their medical records reviewed on study.
DATA SHARING COHORT: Patients have their medical records reviewed on study.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationChildren's Hospital of Philadelphia
Principal InvestigatorTheodore Willis Laetsch
- Primary ID21ST081
- Secondary IDsNCI-2023-06716, IRB 21-018612
- ClinicalTrials.gov IDNCT05024929