Targeted Therapy to Increase RAI Uptake in Metastatic DTC (NCT05024929) | Clinical Trial Compass
RecruitingNot Applicable
Targeted Therapy to Increase RAI Uptake in Metastatic DTC
United States32 participantsStarted 2021-07-16
Plain-language 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.
Who can participate
Age range0 Years
SexALL
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Inclusion criteria
✓. Patients with a histologic diagnosis of differentiated thyroid cancer
✓. 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
✓. Anatomically evaluable disease on chest Computed tomography (CT) meeting oneo f the following criteria (obtained within 180 days of enrollment):
✓. multiple (10 or more) 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 investigational new drug (IND). Such agents include, but are not limited to:
✓. Larotrectinib, entrectinib, selitrectinib, and repotrectinib for NTRK fusions
✓. Selpercatinib and pralsetinib for RET fusions
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 cabozantanib) is allowed.
What they're measuring
1
Proportion of patients with increased tumor RAI-avidity after receiving oncogene-specific, targeted therapy