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Recombinant Human TSH (rhTSH)-Aided Radioiodine (131) Therapy for Thyroid Remnant Ablation in Differentiated Thyroid Cancer Patients: a Comparison Between 1850 MBq and 3700 MBq Activities


Phase 3
18 Years
90 Years
Not Enrolling
Both
Thyroid Cancer

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Trial Information

Recombinant Human TSH (rhTSH)-Aided Radioiodine (131) Therapy for Thyroid Remnant Ablation in Differentiated Thyroid Cancer Patients: a Comparison Between 1850 MBq and 3700 MBq Activities


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.


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

Type of Study:

Observational

Study Design:

Allocation: Random Sample, Observational Model: Natural History, Time Perspective: Longitudinal, Time Perspective: Prospective

Principal Investigator

Furio Pacini, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Section of Endocrinology, University of Siena

Authority:

Italy: Ethics Committee

Study ID:

AIRC 1185

NCT ID:

NCT00454077

Start Date:

December 2004

Completion Date:

September 2006

Related Keywords:

  • Thyroid Cancer
  • thyroid cancer; rhTSH; thyroid ablation
  • Thyroid Neoplasms
  • Thyroid Diseases

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