Targeted Therapy to Increase RAI Uptake in Metastatic DTC
Part of paid clinical trials in San Francisco, California.
- Sponsor
- Children's Hospital of Philadelphia
- Study ID
- NCT05024929
- Status
- Recruiting
Conditions
- Differentiated Thyroid Cancer
- Papillary Thyroid Cancer
- Pediatric Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 0 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Whole body scan — PROCEDUREPatients 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
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.
Key Dates
- Start date
- Jul 16, 2021
- Status verified
- Nov 2025
- Primary completion
- Feb 1, 2031
- Completion
- Feb 1, 2033
Study Design
- Enrollment
- 32 participants (estimated)
Arms
- Arm: Prospective CohortPatients with differentiated thyroid cancer for whom oncogene-specific targeted therapy is planned from commercial supply or as part of a separate therapeutic trial
- Arm: Data Sharing CohortPatients 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
Primary Outcome Measure
Proportion of patients with increased tumor RAI-avidity after receiving oncogene-specific, targeted therapy [ Time Frame: up to 5 years ]
Central Contacts
- Meghan T Donnelly2674269343
- James Robinson215-590-2053
Locations (8)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94143 | |
| Emory University School of Medicine | Atlanta | Georgia | 30322 | Brianna Patterson, MD |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | Junne Kamihara, MD Junne Kamihara, MD (PRINCIPAL_INVESTIGATOR) |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | Theodore Laetsch, MD (PRINCIPAL_INVESTIGATOR) |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | Sara Helmig, MD |
| MD Anderson Cancer Center | Houston | Texas | 77030 | Steven Waguespack, MD Steven Waguespack, MD (PRINCIPAL_INVESTIGATOR) |
| Texas Children's Hospital | Houston | Texas | 77030 | Rajkumar Venkatramani, MD Priya Mahajan, MD (PRINCIPAL_INVESTIGATOR) |
| Seattle Children's Hospital | Seattle | Washington | 98105 | Tyler Ketterl, MD, MS Tyler Ketterl, MD, MS (PRINCIPAL_INVESTIGATOR) |
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