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

Sponsor
Sohag University
Study ID
NCT07056218
Status
Not Yet Recruiting

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Conditions

  • Thyroid Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • neck ultrasound — DEVICE
    ultrasound scan
  • thyroglobulin — DIAGNOSTIC_TEST
    blood test

Study Details

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

Key Dates

First listed
Jul 9, 2025
Start date
Jul 15, 2025
Status verified
Jun 2025
Primary completion
Dec 15, 2026
Completion
Dec 15, 2026

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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

Primary Outcome Measure

outcome of radioactive iodine therapy on thyroid cancer [ Time Frame: 12:18 months ]

Central Contacts

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