Trial NCT05024929
Targeted Therapy to Increase RAI Uptake in Metastatic DTC
- Phase
- Not given
- Sponsor
- Children's Hospital of Philadelphia
- Conditions
- Papillary Thyroid Cancer; Pediatric Cancer; Differentiated Thyroid Cancer
- Ages
- 0+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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.Pregnancy
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.
Restrictions found (1)
- PregnancyOutrightexclusionShow in the text
Recruiting in Massachusetts
- Boston Children's Hospital · Boston, Suffolk County