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

NCT04858867 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-10-10

No results posted yet for this study

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.

Conditions

  • Differentiated Thyroid Cancer

Interventions

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

Sponsors & Collaborators

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • Ellen Kapiteijn, MD, PhD · LUMC

  • Dennis Vriens, MD, PhD · LUMC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-10
Primary Completion
2025-01-01
Completion
2025-06-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04858867 on ClinicalTrials.gov