rhTSH-Thyroid Ablation With 1850 MBq of 131I

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-12-31

Study Completion Date

2006-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Most patients with differentiated thyroid carcinoma (DTC) are treated with therapeutic doses of radioiodine (131I) after initial surgery (total or near total thyroidectomy), aimed to destroy microscopic residual normal or tumoral thyroid cells and to facilitate the early detection of tumor recurrence based on serum thyroglobulin (Tg) measurement and 131I whole body scan (WBS) (1-5). Recently, preparation of patients for thyroid ablation with rhTSH and 3700 MBq of 131I on l-thyroxine (l-T4) therapy has been approved in Europe by the European Medicines Agency (EMEA) as an alternative to thyroid hormone withdrawal (6), after a randomized, controlled, multicenter study demonstrated that both methods of preparation are equally effective (with 100% rate of successful ablation) and that patients prepared with rhTSH received lower total body irradiation and experienced a better quality of life compared to those rendered hypothyroid (7).

The present study was aimed to compare the efficacy of fixed activities of 1850 MBq versus 3700 MBq of 131I for post surgical thyroid ablation in DTC patients prepared with rhTSH (TSHα, Thyrogen®, Genzyme Therapeutics, Cambridge, MA) on l-T4 therapy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Aim: Recently, a multicenter study in differentiated thyroid cancer (DTC) patients showed that 3700 MBq of 131I after rhTSH stimulation had successful post-surgical thyroid ablation rate similar to that obtained after thyroid hormone withdrawal. We investigated whether 1850 MBq of 131I have a rate of successful ablation similar to 3700 MBq in patients prepared with rhTSH.

Methods: Seventy-two patients with DTC were randomly assigned after surgery to receive 1850 MBq (group A, n: 36) or 3700 MBq (group B, n: 36) of 131I after rhTSH. The two groups were comparable for age, sex, histotype and tumor stage. One injection of 0.9 mg of rhTSH was administered for two consecutive days; 131I therapy was delivered 24 hours after the last injection. A post-therapy whole body scan (WBS) was performed 72 hours later. Successful ablation was assessed 6-8 months after therapy.

Results: Successful ablation, defined as no visible uptake in the diagnostic WBS after rhTSH stimulation, was achieved in 88.9% of group A and group B patients. Basal and rhTSH-stimulated serum Tg was undetectable (\<1 ng/ml) in 88.6 % of group A and 84.8% of group B patients (p=0.65). Similar rates of ablation were obtained in both groups also in patients with lymph node metastases. Dosimetric data showed similar thyroid bed uptake, effective half-life and adsorbed dose in the two groups. Failure to ablate was not correlated with TNM staging, peak TSH levels, thyroid bed uptake and urinary iodine excretion at the time of ablation, but was influenced by the absorbed dose of 131I (\< or \>300 Gy).

Conclusion: Our results demonstrate that therapeutic 131I activities of 1850 MBq are equally effective as 3700 MBq for thyroid ablation in DTC patients prepared with rhTSH, even in the presence of lymph node metastases.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Thyroid Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

thyroid cancer; rhTSH; thyroid ablation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

NATURAL_HISTORY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

radioiodine therapy after rhTSH

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Newly diagnosed differentiated thyroid cancer patients, more than 18 years old, recently treated by near total thyroidectomy were eligible for the study

Exclusion Criteria

* Evidence of distant metastases and/or significant local invasion

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Furio Pacini, MD

Role: PRINCIPAL_INVESTIGATOR

Section of Endocrinology, University of Siena

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Section of Endcrinology, University of Siena

Siena, Siena, Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AIRC 1185

Identifier Type: -

Identifier Source: org_study_id