Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-27 @ 11:35 AM
Study NCT ID:
NCT04858867
Status:
UNKNOWN
Last Update Posted:
2023-10-10
First Post:
2021-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reinducing Radioiodine-sensitivity in Radioiodine-refractory DTC Using Lenvatinib (RESET)
Sponsor:
Leiden University Medical Center
Organization:
Study Overview
Official Title:
Reinducing Radioiodine-sensitivity in Radioiodine-refractory Differentiated Thyroid Cancer Using Lenvatinib (RESET)
Status:
UNKNOWN
Status Verified Date:
2023-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESET
Brief Summary:
This is a single-centre open label phase II study evaluating the effect of lenvatinib treatment for restoring radioiodine uptake and retention in radioiodine-refractory (RAI-R) thyroid cancer to warrant I-131 therapy.
Detailed Description:
RAI-R DTC patients starting standard-of-care lenvatinib treatment will be included in this study. Prior to lenvatinib treatment, patients will undergo I-124 PET/CT to quantify RAI uptake and retention at baseline. The first half of the intended sample size (cohort 1) will be treated with lenvatinib for a total of 12 weeks. After 6- and 12-week treatment, patients will undergo I-124 PET/CT dosimetry to evaluate the redifferentiation effect, assess expected absorbed lesion doses and maximum tolerable activity. Results between 6- and 12-week lenvatinib treatment will be compared to select the lenvatinib treatment duration that leads to highest extent of redifferentiation. The next patients (cohort 2) will then receive lenvatinib for either 6 or 12 weeks.
Patients will undergo subsequent I-131 therapy if a clinically meaningful lesion dose is expected and toxicity is deemed acceptable. For all patients eligible for I-131 therapy, lenvatinib is discontinued prior to administration of I-131 and intra-therapeutic I-131 SPECT dosimetry will be performed for dose verification. Patients who are not eligible for I-131 therapy, will continue lenvatinib treatment at the discretion of the treating physician.
Biopsies are performed at baseline and after 6-week lenvatinib treatment to evaluate alterations at the transcriptional and translational level in biopted tumor lesions. Patients will be followed up according to current guidelines for a total of 9 months after initiating lenvatinib treatment. Metabolic and biochemical response will be assessed using F-18 FDG PET/CT and Tg levels, respectively.
Patients will undergo subsequent I-131 therapy if a clinically meaningful lesion dose is expected and toxicity is deemed acceptable. For all patients eligible for I-131 therapy, lenvatinib is discontinued prior to administration of I-131 and intra-therapeutic I-131 SPECT dosimetry will be performed for dose verification. Patients who are not eligible for I-131 therapy, will continue lenvatinib treatment at the discretion of the treating physician.
Biopsies are performed at baseline and after 6-week lenvatinib treatment to evaluate alterations at the transcriptional and translational level in biopted tumor lesions. Patients will be followed up according to current guidelines for a total of 9 months after initiating lenvatinib treatment. Metabolic and biochemical response will be assessed using F-18 FDG PET/CT and Tg levels, respectively.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: