Trial Title:
I-124 PET/CT Based Remnant Radioiodine Ablation Decision Concept in Differentiated Thyroid Cancer
NCT ID:
NCT01704586
Condition:
Differentiated Thyroid Carcinoma
Conditions: Official terms:
Thyroid Neoplasms
Thyroid Diseases
Conditions: Keywords:
Differentiated thyroid carcinoma
PET/CT
Radioiodine Remnant Ablation
I-124
Quality of life
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Radiation
Intervention name:
Radioiodine I-131
Description:
Radioiodine will be used for ablation therapy, dosimetry and posttherapeutic whole body
scan, as well as low dose I-131 imaging.
Arm group label:
Radioiodine
Intervention type:
Radiation
Intervention name:
I-124
Description:
I-124 will be used for imaging to assess uptake inside and outside of thyroid bed, using
PET/CT whole body scanning, followed by I-131 therapy as necessary as per protocol.
Arm group label:
I-124
Summary:
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Clinic of Nuclear Medicine, University Clinic Essen
Address:
City:
Essen
Zip:
45122
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Rainer Görges, MD, Prof.
Phone:
+49201723
Phone ext:
2081
Email:
rainer.goerges@uni-due.de
Contact backup:
Last name:
Ina Binse, MD, PhD
Phone:
+490201723
Phone ext:
2081
Email:
Ina.Binse@uk-essen.de
Investigator:
Last name:
Rainer Görges, MD, Prof.
Email:
Sub-Investigator
Investigator:
Last name:
Ina Binse, MD
Email:
Principal Investigator
Investigator:
Last name:
Hong Grafe, MD
Email:
Sub-Investigator
Facility:
Name:
University Clinic Würzburg
Address:
City:
Würzburg
Zip:
97080
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Peter Schneider, MD, Prof.
Phone:
+49931201
Phone ext:
35010
Email:
schneider_p@ukw.de
Contact backup:
Last name:
Constantin Lapa, MD
Phone:
+49931201
Phone ext:
35005
Email:
Lapa_C@ukw.de
Investigator:
Last name:
Constantin Lapa, MD
Email:
Principal Investigator
Investigator:
Last name:
Johannes Biko, MD
Email:
Sub-Investigator
Start date:
May 2015
Completion date:
November 2025
Lead sponsor:
Agency:
University of Wuerzburg
Agency class:
Other
Collaborator:
Agency:
Deutsche Krebshilfe e.V., Bonn (Germany)
Agency class:
Other
Source:
University of Wuerzburg
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01704586
