NCT05024929 Targeted Therapy to Increase RAI Uptake in Metastatic DTC
| NCT ID | NCT05024929 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital of Philadelphia |
| Condition | Papillary Thyroid Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 32 participants |
| Start Date | 2021-07-16 |
| Primary Completion | 2031-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 32 participants in total. It began in 2021-07-16 with a primary completion date of 2031-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05024929 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, studying Papillary Thyroid Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05024929 currently recruiting?
Yes, NCT05024929 is actively recruiting participants. Contact the research team at donnellymt@chop.edu for enrollment information.
Where is the NCT05024929 trial being conducted?
This trial is being conducted at San Francisco, United States, Atlanta, United States, Boston, United States, Philadelphia, United States and 5 additional locations.
Who is sponsoring the NCT05024929 clinical trial?
NCT05024929 is sponsored by Children's Hospital of Philadelphia. The trial plans to enroll 32 participants.
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