Targeted Therapy to Increase RAI Uptake in Metastatic DTC
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0+
SponsorChildren's Hospital of Philadelphia
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
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
Disqualifiers
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.
Females who are pregnant or breastfeeding are excluded due to the potential risks of the RAI used in the WBS to the fetus/neonate.
Patients who require sedation/general anesthesia to complete a WBS are excluded.
U.S. Military Personnel are excluded due to the Children's Hospital of Philadelphia (CHOP) Institutional Review Board (IRB) requirements.
Trial population
This study will enroll children and adolescents with differentiated thyroid cancer with pulmonary metastases who are planned to receive oncogene-specific targeted therapy.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Whole body scan
Procedure/SurgeryPatients will receive oncogene-specific molecularly targeted therapy independently of this protocol either via commercial supply of an FDA approved agent, or as part of a separate therapeutic clinical trial/compassionate use protocol/single patient investigational new drug (IND). During screening, patients will undergo a baseline RAI-whole body scan (WBS) to assess RAI-avidity of their tumor per standard of care. Following approximately 28 days of targeted therapy, the WBS will be repeated to determine whether this therapy is associated with an increase in RAI-avidity of their tumor.
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Prospective Cohort1 intervention
Group B: Data Sharing Cohort0 interventions
Trial outcomes
Primary outcomes
1
Proportion of patients with increased tumor RAI-avidity after receiving oncogene-specific, targeted therapy
The primary outcome measure is to determine the proportion of patients with differentiated thyroid cancer metastatic to the lungs for whom oncogene-specific, targeted therapy increases tumor RAI-avidity.
Time frame
up to 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital of Philadelphia
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov