AzTrials
AzTrials

Thyroid DiseasesLORIGRAVESNCT03110835

Low-dose Radioiodine Ablation in Graves' Disease

An observational study of Thyroid Diseases, run by University of Pisa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Graves' orbitopathy (GO) is an autoimmune condition almost always associated with autoimmune thyroid disease, especially Graves' disease (GD). According to the most widely accepted model, the autoantigen/s responsible for GO would include molecules expressed by thyroid epithelial cells that are present also in orbital… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Thyroid Diseases
What is being tested?
Radioiodine
Type of treatment
Surgery or procedure
How many people
12 participants
Where
No sites listed yet
Study dates
1 Jan 2016to 28 Mar 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Thyroidectomized patients with Graves' hyperthyroidism and GO undergoing radioiodine ablation with either 15 or 30 mCi of 131I

Who may be able to join

  • Graves' disease at histology
  • Thyroid cancer at histology
  • Undetectable serum anti-thyroglobulin autoantibodies
  • Informed consent

Who cannot join

  • Detectable serum anti-thyroglobulin autoantibodies
  • lack of informed consent

About this study

Official title: Use of Low-dose Radioiodine for Ablation of Thyroid Remnants in Patients With Graves' Disease Following Thyroidectomy

Graves' orbitopathy (GO) is an autoimmune condition almost always associated with autoimmune thyroid disease, especially Graves' disease (GD). According to the most widely accepted model, the autoantigen/s responsible for GO would include molecules expressed by thyroid epithelial cells that are present also in orbital tissues. The high likelihood that the etiologies of GO and of the underlying autoimmune thyroid diseases are somehow linked is confirmed by the very close relationship between GO, the onset and the course of Graves' diseases, the size of the thyroid gland, and most importantly, thyroid function and thyroid treatment. Based on these considerations, it has been proposed that complete removal of thyroid antigens and of thyroid infiltrating lymphocytes, the so called total thyroid ablation (TTA), may be followed by an attenuation of the immune reaction against orbital antigens, and ultimately by an amelioration of GO. The possibility that TTA, achieved by near total thyroidectomy followed by radioiodine, may be beneficial for GO was initially suggested by two retrospective studies and more recently by two prospective, randomized clinical trials conducted in patients with moderate GO treated with intravenous glucocorticoids. Although there seemed to be no difference in the long term, compared with near total thyroidectomy alone TTA was associated with a shorter time required for GO to improve, or anyway to reach its best possible outcome, and with a lesser requirement for additional treatments in order for GO to improve.

TTA is usually performed with a radioiodine dose of 30 millicurie (mCi), administered after 2 injections of recombinant human thyrotropin TSH (rhTSH), the latter in order to induce radioiodine uptake by thyroid remnants. According to the Italian legislation the administration of such a dose of radioiodine must be followed by a 24 hours protected hospitalization. Clearly, this necessity implies a remarkable increase of the waiting list, due to the limited number of radiation-isolated beds available and, concerning GO patients, to the competition with patients with thyroid cancer. In contrast, a radioiodine dose of 15 mCi can be performed in out-patients without hospitalization and with much lower costs. Concerning GD patients, they usually have serum TSH-receptor stimulating antibodies that ay persist after thyroidectomy and that may increase radioiodine uptake along with rhTSH, possibly resulting in the need for a lower dose of radioiodine to ablate thyroid remnants. In order to investigate whether this is the case, the present study was designed in patients with GD. The study design was to include patients scheduled to radioiodine treatment with 30 or 15 mCi after administration of rhTSH, being the primary outcome the values of serum thyroglobulin at peak after administration of rhTSH 6 months after radioiodine, as a measure of the presence of residual thyroid tissue.

Being tested
Radioiodine
Medical subject headings
Thyroid Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RadioiodineRadiation

    Also called 131-Iodine

    Administration of radioiodine

Study groups in NCT03110835
Study groupRoleWhat they receive
15 mCi radioiodine6 patients with low risk differentiated thyroid cancer, as determined by histology
Receives: Radiation: Radioiodine
30 mCi radioiodine6 patients with low risk differentiated thyroid cancer, as determined by histology
Receives: Radiation: Radioiodine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. rhTSH-stimulated serum thyroglobulin (Tg) at 6 months

    Measurement of Tg after 2 injections of rhTSH

    Measured: 6 months

Secondary outcomes (1)
  1. Serum Tg

    Measurement of Tg prior to injections of rhTSH

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2017
  2. Study start1 Jan 2016
  3. Primary completion28 Mar 2017
  4. Study completion28 Mar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03110835
Sponsor's protocol ID
LORIGRAVES
Acronym
LORIGRAVES
Status last verified
Apr 2017
First submitted
14 Mar 2017
Last updated
12 Apr 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Thyroid Diseases, run by University of Pisa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

rhTSH-stimulated serum thyroglobulin (Tg) at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2017.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in