I-124 PET/CT Based Remnant Radioiodine Ablation Decision Concept in Differentiated Thyroid Cancer
NCT ID: NCT01704586
Last Updated: 2020-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
340 participants
INTERVENTIONAL
2015-05-31
2025-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Radioiodine
Standard procedures using only I-131. All patients in this arm will have assigned I-131 ablation, followed by periodic I-131 diagnostic re-evaluations after 4-6 months as needed.
Radioiodine I-131
Radioiodine will be used for ablation therapy, dosimetry and posttherapeutic whole body scan, as well as low dose I-131 imaging.
I-124
I-124 PET/CT guided concept following ATA guideline recommendations after total thyroidectomy. Uptake outside of thyroid bed constitutes I-131 therapy for remnant ablation and metastasis therapy based on I-124 dosimetry. Remnant mass and/or metastasis mass will be estimated by a diagnostic CT scan simultaneously while doing PET at the optimum time point 2-3 days after administration of I-124. If there is no uptake outside of thyroid bed, no ablation will follow in stage I disease according to AJCC 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). Periodic follow-up may include I-124 PET/CT when indicated to determine whether or not another I-131 therapy has to follow. Thyroglobuline increase also constitutes I-124 PET/CT imaging.
I-124
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.
Interventions
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Radioiodine I-131
Radioiodine will be used for ablation therapy, dosimetry and posttherapeutic whole body scan, as well as low dose I-131 imaging.
I-124
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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.
Exclusion Criteria
* 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:
18 Years
80 Years
ALL
No
Sponsors
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Deutsche Krebshilfe e.V., Bonn (Germany)
OTHER
University of Wuerzburg
OTHER
Responsible Party
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Manuel Weber, Dr. med..
Acad. Dir.
Principal Investigators
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Peter F Schneider, MD, Prof.
Role: STUDY_CHAIR
University Clinic Würzburg, Department of Nuclear Medicine
Ina Binse, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Universiity Clinic Essen, Department of Nuclear Medicine
Locations
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Clinic of Nuclear Medicine, University Clinic Essen
Essen, , Germany
University Clinic Würzburg
Würzburg, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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American Thyroid Association (ATA) Guidelines Taskforce on Thyroid Nodules and Differentiated Thyroid Cancer; Cooper DS, Doherty GM, Haugen BR, Kloos RT, Lee SL, Mandel SJ, Mazzaferri EL, McIver B, Pacini F, Schlumberger M, Sherman SI, Steward DL, Tuttle RM. Revised American Thyroid Association management guidelines for patients with thyroid nodules and differentiated thyroid cancer. Thyroid. 2009 Nov;19(11):1167-214. doi: 10.1089/thy.2009.0110.
Luster M, Clarke SE, Dietlein M, Lassmann M, Lind P, Oyen WJ, Tennvall J, Bombardieri E; European Association of Nuclear Medicine (EANM). Guidelines for radioiodine therapy of differentiated thyroid cancer. Eur J Nucl Med Mol Imaging. 2008 Oct;35(10):1941-59. doi: 10.1007/s00259-008-0883-1.
Hay ID. Selective use of radioactive iodine in the postoperative management of patients with papillary and follicular thyroid carcinoma. J Surg Oncol. 2006 Dec 15;94(8):692-700. doi: 10.1002/jso.20696.
Hanscheid H, Lassmann M, Luster M, Thomas SR, Pacini F, Ceccarelli C, Ladenson PW, Wahl RL, Schlumberger M, Ricard M, Driedger A, Kloos RT, Sherman SI, Haugen BR, Carriere V, Corone C, Reiners C. Iodine biokinetics and dosimetry in radioiodine therapy of thyroid cancer: procedures and results of a prospective international controlled study of ablation after rhTSH or hormone withdrawal. J Nucl Med. 2006 Apr;47(4):648-54.
Tagay S, Herpertz S, Langkafel M, Erim Y, Bockisch A, Senf W, Gorges R. Health-related Quality of Life, depression and anxiety in thyroid cancer patients. Qual Life Res. 2006 May;15(4):695-703. doi: 10.1007/s11136-005-3689-7.
Lassmann M, Reiners C, Luster M. Dosimetry and thyroid cancer: the individual dosage of radioiodine. Endocr Relat Cancer. 2010 Jun 3;17(3):R161-72. doi: 10.1677/ERC-10-0071. Print 2010 Sep.
Verburg FA, Lassmann M, Mader U, Luster M, Reiners C, Hanscheid H. The absorbed dose to the blood is a better predictor of ablation success than the administered 131I activity in thyroid cancer patients. Eur J Nucl Med Mol Imaging. 2011 Apr;38(4):673-80. doi: 10.1007/s00259-010-1689-5. Epub 2011 Jan 6.
Passler C, Prager G, Scheuba C, Kaserer K, Zettinig G, Niederle B. Application of staging systems for differentiated thyroid carcinoma in an endemic goiter region with iodine substitution. Ann Surg. 2003 Feb;237(2):227-34. doi: 10.1097/01.SLA.0000048449.69472.81.
Other Identifiers
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UKW-NUK-I-124
Identifier Type: -
Identifier Source: org_study_id