Ignite Creation Date:
2024-05-06 @ 12:59 AM
Last Modification Date:
2024-10-26 @ 10:57 AM
Study NCT ID:
NCT01704586
Status:
RECRUITING
Last Update Posted:
2020-11-04
First Post:
2012-10-04
Brief Title:
I-124 PETCT Based Remnant Radioiodine Ablation Decision Concept in Differentiated Thyroid Cancer
Sponsor:
University of Wuerzburg
Organization:
University of Wuerzburg
Study Overview
Official Title:
Clinical Evaluation of a I-124 PETCT Based Remnant Radioiodine Ablation Decision Concept in Differentiated Thyroid Cancer Using PROBE Design
Status:
RECRUITING
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLERAD-PROBE
Brief 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 7000 new cases will be diagnosed in 2011 The yearly incidence has increased from 36 per 100000 in 1973 to 87 per 100000 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 UICCAJCC 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 028 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
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 UICCAJCC 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 028 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None