NCT01704586Active, not recruiting

I-124 PET/CT Based Remnant Radioiodine Ablation Decision Concept in Differentiated Thyroid Cancer

Clinical Evaluation of a I-124 PET/CT Based Remnant Radioiodine Ablation Decision Concept in Differentiated Thyroid Cancer Using PROBE Design

Source: ClinicalTrials.gov · Last updated 9 Oct 2026

Brief summary (registry, in English)

Thyroid nodules are a common clinical problem. Epidemiologic studies have shown the prevalence of palpable thyroid nodules to be approximately 5% in women and 1% in men living in iodine-sufficient parts of the world and up to 30% in iodine deficient regions, such as Germany. The clinical importance of thyroid nodules rests with the need to exclude thyroid cancer which occurs in 5-15%. Differentiated thyroid cancer (DTC), which includes papillary and follicular cancer, comprises the vast majority (90%) of all thyroid cancers. In Germany, approximately 7,000 new cases will be diagnosed in 2011. The yearly incidence has increased from 3.6 per 100,000 in 1973 to 8.7 per 100,000 in 2002, and this trend appears to be continuing. Recurrence-free survival is generally excellent and depends on the risk group. The role of postoperative remnant radioiodine ablation (RRIA) as the most serious question regarding the initial management of DTC still needs to be resolved even after decades of radioiodine use. American Thyroid Association directions for future research addressing these questions include: * Better understanding of the long-term risks of radioiodine use; * Improved risk stratification; Randomized controlled trials are still missing in which RRIA has proven its worth as a safe and very effective treatment that results in an improved life expectancy and a reduced recurrence rate. Many observational studies lack sufficiently high evidence. Evidence grade is rated mainly on "expert level", based on non-randomized retrospective observation studies. Although RRIA in Europe is established as adjuvant standard treatment for all patients with DTC, except those with stage T1a, it remains to be shown throughout if it is beneficial for low risk and medium risk patients without metastases (M0), also known as stage I patients according to UICC/AJCC classification, accounting for 40-90% of all patients. Blood doses due to cumulative radioiodine therapy may well exceed 2 Gy, and RRIA induces an average blood dose of 0.28 Gy to the entire body. Risks as estimated from that dose are not insignificant. The question is whether or not the condition after remnant ablation justifies such an increased risk of a secondary malignancy. The probability of causation for a pharyngeal or breast tumour can well exceed the margin of a 50% after being exposed to RRIA or consecutive I-131 diagnostic imaging to explore measureable Tg levels. Even though radioiodine therapy can benefit some patients with advanced thyroid carcinoma, it is still unknown whether the risks of RRIA outweigh any discernable benefit. Undoubtedly, quality of life may be affected by adjuvant use of I-131. Study Hypothesis: The I-124 study arm may have considerable benefits for the patient included in the study. These include * enhanced tumour and risk stratification, * avoidance of unnecessary I-131 exposure in 30-89 percent of patients who were classified with "low risk" tumour (MACIS or AMES scoring) or "stage I disease" (UICC-AJCC TNM staging system), and, * improved quality of life at the same or better morbidity and mortality rates in the I-124 arm. Environmental and hospital staff related benefits include prevention or saving of I-131 exposure. This study is designed to compare effectiveness of treatments following and evaluating guideline recommendations in two assignment arms.

Status (registry): Active, not recruiting
Study type: Interventional
Enrollment: 340 (estimated)
First submitted: 4 Oct 2012
Start date: May 2015
Primary completion date: May 2021
Lead sponsor: University of Wuerzburg
Diseases: Thyroid cancer
NCT number: NCT01704586

What you commit to

Study type: Interventional
Planned participants: 340
From May 2015 to the primary completion date, May 2021
2 sites in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

R2 (if no redo surgery)

Other illness

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.
Microscopical residual disease (R1) and/or aggressive malignant histologic subtypes, including tall-cell, insular, poorly differentiated and diffuse sclerosing thyroid cancer, columnar cell variant: according to the recommendation of the local tumour board
- B: Inclusion criteria (high risk DTC):
Microscopical residual disease (R1) and/or aggressive malignant histologic subtypes, including tall-cell, insular, poorly differentiated and diffuse sclerosing thyroid cancer, columnar cell variant: according to the recommendation of the local tumour board

Lab values

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.

Age

Papillary or follicular carcinoma with the possibility of lymph node involvement but no distant metastasis and no macroscopical (R2) residual disease (Patient age \<45y: T1-T2, T3 limited to the thyroid, any N, M0; Patient age 45y or older: T1-T2, N0, M0)

Other

Anaplastic or medullary carcinoma
Positive pregnancy test or breast feeding
Recent iodine contamination
- After Randomisation:
- I-124 arm (Arm 1):
- A: Inclusion criteria for no remnant ablation (low risk DTC):
I-124 uptake only in thyroid bed
All other \[TNM\] stages (stage II to stage IV C) and T3 (any size with minimal extrathyroidal extension)
AND I-124 uptake in or outside thyroid bed
OR low risk showing 124 uptake outside of the thyroid bed
- Standard arm (Arm 2):
Standard I-131 ablation concept as defined for all T1a(m) to T4 subjects.

Who the study is looking for

Histologically confirmed new diagnosis of DTC (including Hürthle-cell carcinoma)
Age 18-80 years
Performance Status of 0-2
Tumor stage T1a(m) 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

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Clinic of Nuclear Medicine, University Clinic Essen Coordinator of this site? Confirm its status	Essen	Germany	Unknown status
University Clinic Würzburg Coordinator of this site? Confirm its status	Würzburg	Germany	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.