NCT04858867

Reinducing Radioiodine-sensitivity in Radioiodine-refractory DTC Using Lenvatinib (RESET)

Reinducing Radioiodine-sensitivity in Radioiodine-refractory Differentiated Thyroid Cancer Using Lenvatinib (RESET)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Differentiated Thyroid Cancer

Interventions

Type	Name	Description
RADIATION	rhTSH-stimulated I-124 dosimetry	Preparation: * Low iodine diet 7 days prior to I-124 ingestion until 24 hours post-ingestion * Thyrogen injections 24 and 48h prior to I-124 ingestion Procedures following Jentzen et al: * Ingestion of capsule with 37±10% MBq I-124 * I-124 PET/CT at 24 and 96h post-ingestion * Blood draws at 2, 24 and 96h post-ingestion * Whole body counting at 2, 24 and 96h post-ingestion
RADIATION	Intra-therapeutic I-131 dosimetry	Procedures following EANM guidelines: * I-131 SPECT/CT at 2, 6, 24, 96 and 144h post-ingestion * Blood draws at 2, 6, 24, 96 and 144h post-ingestion * Whole body counting at 2, 6, 24, 96 and 144h post-ingestion

Timeline

• Start date: 2022-01-10
• Primary completion: 2025-01-01
• Completion: 2025-06-01
• First posted: 2021-04-26
• Last updated: 2023-10-10

Locations

1 site across 1 country: Netherlands