Targeted Therapy to Increase RAI Uptake in Metastatic PTC
Study Details
Study Description
Brief Summary
Papillary thyroid cancer (PTC) is a common type of thyroid cancer in children and represents the second most common cancer in adolescent females. Recently targeted drugs that block many of the genetic drivers of PTC have become available. While Investigators know that these drugs shrink PTC tumors in many cases, the impact on radioactive iodine (RAI) avidity has not been systematically studied.
| Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
This is an observational cohort study that will enroll patients with PTC metastatic to the lungs who will receive oncogene-specific targeted therapy as part of routine clinical care. After approximately 1 week of therapy, patients will have a whole body scan to determine the change in RAI-avidity of the tumor from baseline. Subsequent therapy will be at the discretion of the treating physician.
Study Design
Outcome Measures
Primary Outcome Measures
- Proportion of patients with increased tumor RAI-avidity after receiving oncogene-specific, targeted therapy [up to 5 years]
The primary outcome measure is to determine the proportion of patients with papillary thyroid cancer metastatic to the lungs for whom oncogene-specific, targeted therapy increases tumor RAI-avidity.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age less than 22 years
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Patients with a histologic diagnosis of papillary throid cancer
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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 and College of American Pathologists (CLIA/CAP) laboratory
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Anatomically evaluable disease on chest Computed tomography (CT) (i.e. visible tumor on a chest CT; tumors do not need to be >1 centimeter (cm)
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Patients for whom systemic therapy with an oncogene-specific kinase inhibitor is planned either from commercial supply or as part of a separate therapeutic clinical trial/compassionate access protocol/single patient investigational new drug (IND).
Such agents include, but are not limited to:
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Larotrectinib, entrectinib, selitrectinib, and repotrectinib for NTRK fusions
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Selpercatinib and pralsetinib for RET fusions
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Crizotinib, lorlatinib, repotrectinib, and alectinib for ALK fusions
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Dabrafenib and/or trametinib for BRAF V600 mutations
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Trametinib and selumetinib for BRAF fusions
Exclusion Criteria:
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No prior oncogene-specific targeted therapy allowed. However, patients may enroll within 7 days 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.
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Females who are pregnant or breastfeeding are excluded due to the potential risks of the RAI used in the WBS to the fetus/neonate.
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Patients who require sedation/general anesthesia to complete a WBS are excluded.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- Children's Hospital of Philadelphia
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21-018612