Using I-124 PET/CT to guide treatment decisions in thyroid cancer
Clinical Evaluation of a I-124 PET/CT Based Remnant Radioiodine Ablation Decision Concept in Differentiated Thyroid Cancer Using PROBE Design
This study is testing if a special type of imaging can help doctors decide if patients with thyroid cancer need a specific treatment to improve their outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 340 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Wuerzburg Academic / other |
| Locations | 2 sites (Essen and 1 other locations) |
| Trial ID | NCT01704586 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of I-124 PET/CT imaging to inform decisions regarding remnant radioiodine ablation in patients with differentiated thyroid carcinoma (DTC). The study aims to improve patient outcomes by determining the necessity of radioiodine treatment based on precise imaging results. Participants will include adults aged 18-80 with a confirmed diagnosis of DTC, and the trial will assess the effectiveness of I-124 in guiding treatment decisions compared to traditional methods. The study is conducted at multiple locations in Germany, including the University Clinic Essen and the University Clinic Würzburg.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with a histologically confirmed diagnosis of differentiated thyroid carcinoma.
Not a fit: Patients with anaplastic or medullary carcinoma, or those with a history of prior malignancy within the past 5 years, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized treatment plans and improved quality of life for patients with differentiated thyroid cancer.
How similar studies have performed: Other studies have shown promising results using advanced imaging techniques for treatment decision-making in cancer, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria common for all study subjects prior to randomisation: * Histologically confirmed new diagnosis of DTC (including Hürthle-cell carcinoma) * Age 18-80 years * Performance Status of 0-2 * Tumor stage T1b to T4 with the possibility of lymph node involvement and distant metastasis according to the \[TNM\] staging system * One- or two stage thyroidectomy, with or without central lymph node dissection * Patient´s written informed consent * Ability to comply with the protocol procedures Exclusion criteria for all study subjects prior to randomisation: * Anaplastic or medullary carcinoma * History of prior malignancy within the past 5 years with limited life-time expectancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, or other treated malignancies with no evidence of disease for at least three years. * Positive pregnancy test or breast feeding * Any other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study. * Recent iodine contamination After Randomisation I-124 arm: A: Inclusion criteria for no remnant ablation (low risk DTC): * Stage I (according to AJCC, ref. 1,33) papillary or follicular carcinoma with the possibility of lymph node involvement but no distant metastasis and no microscopical residual disease (Patient age \<45y: any T, any N, M0; Patient age 45y or older: T1, N0, M0) * I-124 uptake only in thyroid bed * Absence of aggressive malignant histologic subtypes, including tall-cell, insular, poorly differentiated and diffuse sclerosing thyroid cancer B: Inclusion criteria for remnant ablation (high risk DTC): * All other \[TNM\] stages (stage II to stage IV C) * Presence of aggressive malignant histologic subtypes, including tall-cell, insular, poorly differentiated and diffuse sclerosing thyroid cancer * I-124 uptake in and outside thyroid bed Standard arm: -Standard I-131 ablation concept as defined for all T1b to T4 subjects.
Where this trial is running
Essen and 1 other locations
- Clinic of Nuclear Medicine, University Clinic Essen — Essen, Germany (Recruiting)
- University Clinic Würzburg — Würzburg, Germany (Recruiting)
Study contacts
- Principal investigator: Ina Binse, MD, PhD — Universiity Clinic Essen, Department of Nuclear Medicine
- Study coordinator: Peter Schneider, MD, Prof.
- Email: schneider_p@ukw.de
- Phone: +49931201
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.