Papillary Thyroid CancerNCT05024929
Targeted Therapy to Increase RAI Uptake in Metastatic DTC
An observational study of Papillary Thyroid Cancer and Pediatric Cancer, run by Children's Hospital of Philadelphia at 9 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Papillary Thyroid Cancer, Pediatric Cancer, Differentiated Thyroid Cancer
- What is being tested?
- Whole body scan
- Type of treatment
- Surgery or procedure
- How many people
- 32 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 16 Jul 2021to 1 Feb 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study will enroll children and adolescents with differentiated thyroid cancer with pulmonary metastases who are planned to receive oncogene-specific targeted therapy.
Who may be able to join
- 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
- Anatomically evaluable disease on chest Computed tomography (CT) meeting oneo f the following criteria (obtained within 180 days of enrollment):
- 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
- 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:
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- Larotrectinib, entrectinib, selitrectinib, and repotrectinib for NTRK fusions
- Selpercatinib and pralsetinib for RET fusions
- Crizotinib, lorlatinib, repotrectinib, and alectinib for ALK fusions
- Dabrafenib and/or trametinib for BRAF V600 mutations
- Oncogene-specific kinase inhibitors other than those specifically delineated above must be approved by the overall study PI prior to enrollment
- 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.
Who cannot join
- 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 locations and contacts
9 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 2 countries
United States8 sites, 8 recruiting
- Recruiting
Emory University School of Medicine
Atlanta, Georgia, 30322
Brianna Patterson, MD
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Junne Kamihara, MD
Junne Kamihara, MD
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Steven Waguespack, MD
Steven Waguespack, MD
- Recruiting
Texas Children's Hospital
Houston, Texas, 77030
Rajkumar Venkatramani, MD
Priya Mahajan, MD
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Sara Helmig, MD
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Meghan T Donnelly, 267-436-9343, donnellymt@chop.edu
James Robinson, 215-590-2053, robinsonj9@chop.edu
- Recruiting
University of California San Francisco
San Francisco, California, 94143
Arun Rangaswami, MD, 415-298-9434, karina.wong@ucsf.edu
Karina Wong, 415-298-9434, karina.wong@ucsf.edu
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Tyler Ketterl, MD, MS
Tyler Ketterl, MD, MS
Australia1 site, 1 recruiting
- Recruiting
Children's Hospital Westmead
Sydney, New South Wales
Paul Benitez-Aguirre, MD
About this study
Official title: Targeted Therapy to Increase RAI Uptake in Patients With Metastatic Differentiated Thyroid Cancer
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.
Read the detailed description
This is an observational cohort study that will enroll patients with DTC metastatic to the lungs who will receive oncogene-specific targeted therapy as part of routine clinical care or a separate therapeutic clinical trial. After approximately 4 weeks of therapy, patients will have a whole body scan to determine the change in RAI-avidity of their tumor from baseline. Subsequent therapy will be at the discretion of the treating physician or according to the therapeutic trial on which the patient is enrolled.
- Being tested
- Whole body scan
- Medical subject headings
- Thyroid Cancer, Papillary, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole body scanProcedure or surgery
Patients 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.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Cohort | Patients with differentiated thyroid cancer for whom oncogene-specific targeted therapy is planned from commercial supply or as part of a separate therapeutic trial Receives: Procedure: Whole body scan | |
| Data Sharing Cohort | Patients with differentiated thyroid cancer 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start16 Jul 2021
- Primary completion1 Feb 2031 (estimated)
- Study completion1 Feb 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillary Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05024929
- Sponsor's protocol ID
- 21-018612
- Status last verified
- Nov 2025
- First submitted
- 23 Aug 2021
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Therapy to Increase RAI Uptake in Patients With Metastatic Differentiated Thyroid Cancer
- ClinicalTrials.gov ID
- NCT05024929
- Acronym / sponsor ID
- 21-018612
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 16 Jul 2021 (actual)
- Primary completion
- 1 Feb 2031 (estimated)
- Study completion
- 1 Feb 2033 (estimated)
- First posted
- 27 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an observational cohort study that will enroll patients with DTC metastatic to the lungs who will receive oncogene-specific targeted therapy as part of routine clinical care or a separate therapeutic clinical trial. After approximately 4 weeks of therapy, patients will have a whole body scan to determine the change in RAI-avidity of their tumor from baseline. Subsequent therapy will be at the discretion of the treating physician or according to the therapeutic trial on which the patient is enrolled.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective Cohort | – | Procedure: Whole body scanPatients with differentiated thyroid cancer for whom oncogene-specific targeted therapy is planned from commercial supply or as part of a separate therapeutic trial |
| Data Sharing Cohort | – | –Patients with differentiated thyroid cancer 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 |
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will enroll children and adolescents with differentiated thyroid cancer with pulmonary metastases who are planned to receive oncogene-specific targeted therapy.
Key inclusion criteria (12 listed)
- 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
- Anatomically evaluable disease on chest Computed tomography (CT) meeting oneo f the following criteria (obtained within 180 days of enrollment):
- 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. 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole body scanPatients 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. | Procedure or surgery | Prospective Cohort |
Primary outcome
Proportion of patients with increased tumor RAI-avidity after receiving oncogene-specific, targeted therapy
Time frame: up to 5 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Individual participant dataSharing planned: No
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Serum Treg/Th17-Related Cytokines and Systemic Inflammatory Indices in Differentiated Thyroid Cancer
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Studies on Tumors of the Thyroid
Hurthle Cell Thyroid Cancer, Tall Cell Variant Thyroid Cancer
Active, not recruitingPhase 3
A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Papillary Thyroid Cancer and Pediatric Cancer, run by Children's Hospital of Philadelphia at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meghan T Donnelly (2674269343, donnellymt@chop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with increased tumor RAI-avidity after receiving oncogene-specific, targeted therapy (time frame: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.