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

Sohag University

Status: Not yet enrolling

Conditions: Thyroid Cancer

Treatments: Diagnostic Test: thyroglobulin; Device: neck ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT07056218

Soh-Med-25-6-7MS

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

50 participants in 2 patient groups

low risk

Description:

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.

Treatment:

Device: neck ultrasound

Diagnostic Test: thyroglobulin

intermediate risk

Description:

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

Treatment:

Device: neck ultrasound

Diagnostic Test: thyroglobulin