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Back|NCT05024929Recruiting
Official Title

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

Sponsor
Children's Hospital of Philadelphia
Enrollment
32
Timeline
Jul 2021 → Feb 2033
About This Study

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 Criteria

  • 1Patients with a histologic diagnosis of differentiated thyroid cancer
  • 2Presence 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
  • 3Anatomically evaluable disease on chest Computed tomography (CT) meeting oneo f the following criteria (obtained within 180 days of enrollment):
  • 4multiple (10 or more) noncalcified solid pulmonary nodules visible on CT and/or
  • 5enlarging, discrete pulmonary nodules visible on CT of any number consistent with metastatic disease
  • 6Patients 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:
  • 7Larotrectinib, entrectinib, selitrectinib, and repotrectinib for NTRK fusions
  • 8Selpercatinib and pralsetinib for RET fusions
  • 9Crizotinib, lorlatinib, repotrectinib, and alectinib for ALK fusions
  • 10Dabrafenib and/or trametinib for BRAF V600 mutations
  • 11Oncogene-specific kinase inhibitors other than those specifically delineated above must be approved by the overall study PI prior to enrollment
  • 121\. 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

  • 1No 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.
  • 2Females who are pregnant or breastfeeding are excluded due to the potential risks of the RAI used in the WBS to the fetus/neonate.
  • 3Patients who require sedation/general anesthesia to complete a WBS are excluded.
  • 4U.S. Military Personnel are excluded due to the Children's Hospital of Philadelphia (CHOP) Institutional Review Board (IRB) requirements.

Locations

9 sites participating in this study

Emory University School of Medicine

Atlanta, Georgia 30322

Recruiting

Brianna Patterson, MD

University of California San Francisco

San Francisco, California 94143

Recruiting

Arun Rangaswami, MD

karina.wong@ucsf.edu415-298-9434

Boston Children's Hospital

Boston, Massachusetts 02115

Recruiting

Junne Kamihara, MD

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →