What this study is
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.
What's being tested
- Whole body scan
Intervention · PROCEDURE
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 details
- Official title
- Targeted Therapy to Increase RAI Uptake in Patients With Metastatic Differentiated Thyroid Cancer
- Sponsor
- Children's Hospital of Philadelphia
- Conditions
- Papillary Thyroid Cancer · Pediatric Cancer · Differentiated Thyroid Cancer
- Enrolling
- 32 people
- Starts
- 2021-07-16
- Est. completion
- 2033-02-01
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 0 Years and overSex ALLHealthy volunteers Not acceptedProspective Cohort
You may qualify if
- 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:; 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
You can't join if
- 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.
Data Sharing Cohort
You may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (9)
9 openUniversity of California San Francisco
San Francisco, California, United States
- Arun Rangaswami, MD · Contact415-298-9434karina.wong@ucsf.edu
- Karina Wong · Contact415-298-9434karina.wong@ucsf.edu
RecruitingEmory University School of Medicine
Atlanta, Georgia, United States
- Brianna Patterson, MD · Contact
RecruitingBoston Children's Hospital
Boston, Massachusetts, United States
- Junne Kamihara, MD · Contact
- Junne Kamihara, MD · Principal investigator
RecruitingChildren's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
- Meghan T Donnelly · Contact267-436-9343donnellymt@chop.edu
- James Robinson · Contact215-590-2053robinsonj9@chop.edu
- Theodore Laetsch, MD · Principal investigator
RecruitingSt. Jude Children's Research Hospital
Memphis, Tennessee, United States
- Sara Helmig, MD · Contact
RecruitingMD Anderson Cancer Center
Houston, Texas, United States
- Steven Waguespack, MD · Contact
- Steven Waguespack, MD · Principal investigator
RecruitingTexas Children's Hospital
Houston, Texas, United States
- Rajkumar Venkatramani, MD · Contact
- Priya Mahajan, MD · Principal investigator
RecruitingSeattle Children's Hospital
Seattle, Washington, United States
- Tyler Ketterl, MD, MS · Contact
- Tyler Ketterl, MD, MS · Principal investigator
Recruiting
1 site outside the US
Children's Hospital Westmead
Sydney, New South Wales, Australia
- Paul Benitez-Aguirre, MD · Contact
Recruiting
Study team
Sponsor
Children's Hospital of Philadelphia
Study ID 21-018612
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.