Targeted therapy to improve radioactive iodine uptake in metastatic thyroid cancer
Targeted Therapy to Increase RAI Uptake in Patients With Metastatic Differentiated Thyroid Cancer
This study is testing if a targeted therapy can help improve how well radioactive iodine works on lung tumors in patients with advanced thyroid cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 32 (estimated) |
| Ages | 0 Years and up |
| Sex | All |
| Sponsor | Children's Hospital of Philadelphia Academic / other |
| Drugs / interventions | Larotrectinib, entrectinib, selitrectinib, repotrectinib, Selpercatinib, pralsetinib, Crizotinib, lorlatinib, alectinib, trametinib, lenvatinib |
| Locations | 9 sites (San Francisco, California and 8 other locations) |
| Trial ID | NCT05024929 on ClinicalTrials.gov |
What this trial studies
This observational cohort study focuses on patients with differentiated thyroid cancer (DTC) that has metastasized to the lungs. Participants will receive oncogene-specific targeted therapy as part of their routine clinical care or a separate therapeutic clinical trial. After approximately four weeks of treatment, patients will undergo a whole body scan to assess changes in the radioactive iodine (RAI) avidity of their tumors compared to baseline measurements. The subsequent treatment plan will be determined by the treating physician or based on the therapeutic trial protocol.
Who should consider this trial
Good fit: Ideal candidates include patients with a histologic diagnosis of differentiated thyroid cancer and specific genetic alterations who have metastatic disease in the lungs.
Not a fit: Patients without the specified genetic alterations or those with non-metastatic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the effectiveness of radioactive iodine treatment for patients with metastatic differentiated thyroid cancer.
How similar studies have performed: While targeted therapies have shown promise in shrinking tumors, the specific impact on RAI avidity in this context has not been systematically studied, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
San Francisco, California and 8 other locations
- University of California San Francisco — San Francisco, California, United States (Recruiting)
- Emory University School of Medicine — Atlanta, Georgia, United States (Recruiting)
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States (Recruiting)
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- Texas Children's Hospital — Houston, Texas, United States (Recruiting)
- Seattle Children's Hospital — Seattle, Washington, United States (Recruiting)
- Children's Hospital Westmead — Sydney, New South Wales, Australia (Recruiting)
Study contacts
- Study coordinator: Meghan T Donnelly
- Email: donnellymt@chop.edu
- Phone: 2674269343
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.