Outcome of RAI131 Therapy in Patients With Differentiated Thyroid Cancer (Low and Intermediate Risk)

NCT ID: NCT07056218

Last Updated: 2025-07-09

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-15

Study Completion Date

2026-12-15

Brief Summary

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Thyroid cancer is a universally relatively rare neoplasm, accounting for nearly 1-5% of all female cancers and less than 2% of male cancers. In spite of this relatively low incidence, it occupies the first rank among the most common endocrinal malignancies, with a consistent male to female ratio of 1: 3 observed in nearly all ethnic groups and geographic areas.

Differentiated thyroid cancer (DTC) is rated as slowly growing disease with a fairly good outcome where the five-year survival rate for localized tumor is 99.8% Total thyroidectomy, the removal of the entire thyroid gland, is the most common surgical approach-especially for tumors larger than 1 cm, multifocal disease, or suspected lymph node involvement. Lobectomy may be considered for small, low-risk tumors (\<1 cm) confined to a single lobe. If lymph node metastasis is evident clinically or radiologically, neck dissection is performed. Postoperative radioactive iodine (RAI) therapy is used to ablate residual tissue or treat recurrent disease, particularly in iodine-avid tumors and intermediate- to high-risk patients. It may not be necessary for small, low-risk tumors. Thyroid hormone suppression therapy with levothyroxine serves both to replace thyroid hormone and suppress TSH, which could stimulate cancer growth. Long-term monitoring includes serial thyroglobulin (Tg) levels (along with anti-Tg antibodies if needed), neck ultrasound, and, in some cases, additional imaging like RAI scans or PET/CT to detect recurrence

Detailed Description

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Conditions

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Thyroid Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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low risk

patients typically have intrathyroidal papillary or follicular carcinoma, tumors \<4 cm, no lymph node metastasis or only \<5 small-volume (\<0.2 cm) mico metastases, no vascular invasion (for follicular type), no aggressive histologic features, and no local or distant metastases.

neck ultrasound

Intervention Type DEVICE

ultrasound scan

thyroglobulin

Intervention Type DIAGNOSTIC_TEST

blood test

intermediate risk

includes cases with microscopic extrathyroidal extension (ETE), cervical lymph node metastases (especially \>5 nodes or \>0.2 cm), vascular invasion, aggressive histologic variants, or RAI-avid distant metastases

neck ultrasound

Intervention Type DEVICE

ultrasound scan

thyroglobulin

Intervention Type DIAGNOSTIC_TEST

blood test

Interventions

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neck ultrasound

ultrasound scan

Intervention Type DEVICE

thyroglobulin

blood test

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

\- Pathologically or cytologically proven differentiated thyroid cancer.

* Total thyroidectomy with or without lymph node dissection
* Patient was treated by RAI after surgery
* Male and female patients
* Age \>18 yrs

Exclusion Criteria

* 1\) Patients with undifferentiated thyroid cancer. 2) patients with high risk (distant metastasis) 3)patient with double malignancy 4) medullary thyroid cancer 4) Patient age \< 18 years. 5)patient not treated by surgery or RAI
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Rana Ashraf Sabry

resident at oncology department nuclear medicine unit sohag university

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Rana A Sabry, resident

Role: CONTACT

01008706603

Wafaa A Elsayed, assisstant lecturer

Role: CONTACT

References

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Liu Y, Su L, Xiao H. Review of Factors Related to the Thyroid Cancer Epidemic. Int J Endocrinol. 2017;2017:5308635. doi: 10.1155/2017/5308635. Epub 2017 May 2.

Reference Type BACKGROUND
PMID: 28555155 (View on PubMed)

Baloch ZW, Asa SL, Barletta JA, Ghossein RA, Juhlin CC, Jung CK, LiVolsi VA, Papotti MG, Sobrinho-Simoes M, Tallini G, Mete O. Overview of the 2022 WHO Classification of Thyroid Neoplasms. Endocr Pathol. 2022 Mar;33(1):27-63. doi: 10.1007/s12022-022-09707-3. Epub 2022 Mar 14.

Reference Type BACKGROUND
PMID: 35288841 (View on PubMed)

Tondi Resta I, Gubbiotti MA, Montone KT, Livolsi VA, Baloch ZW. Differentiated high grade thyroid carcinomas: Diagnostic consideration and clinical features. Hum Pathol. 2024 Feb;144:53-60. doi: 10.1016/j.humpath.2024.01.002. Epub 2024 Jan 19.

Reference Type BACKGROUND
PMID: 38244615 (View on PubMed)

do Prado Padovani R, Duarte FB, Nascimento C. Current practice in intermediate risk differentiated thyroid cancer - a review. Rev Endocr Metab Disord. 2024 Feb;25(1):95-108. doi: 10.1007/s11154-023-09852-y. Epub 2023 Nov 23.

Reference Type BACKGROUND
PMID: 37995023 (View on PubMed)

Other Identifiers

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Soh-Med-25-6-7MS

Identifier Type: -

Identifier Source: org_study_id

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