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RECRUITINGOBSERVATIONAL

Targeted Therapy to Increase RAI Uptake in Metastatic DTC

Targeted Therapy to Increase RAI Uptake in Patients With Metastatic Differentiated Thyroid Cancer

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

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): ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

PROCEDURE

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.

Locations (9)

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