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NCT Number: NCT07314255

The Role of Trop2 in Radioactive Iodine-131 Therapy Sensitivity in Papillary Thyroid Carcinoma

Clinincal data and pathological specimens from patients who had undergone at least one radioactive iodine-131 (^131I) therapy in the Department of Nuclear Medicine at Jiangxi Cancer Hospital over the past 8-10 years were retrospectively collected (approximately 30-50 cases each in the ^131I treatment-responsive group vs. the ^131I treatment-resistant group). Patients in the ^131I treatment-resistant group underwent ^18F-Trop2 PET-CT imaging.

Inclusion criteria:

1. History of total thyroidectomy with postoperative pathology confirming papillary thyroid carcinoma (PTC); 2. At least one course of ^131I internal radiotherapy.

Exclusion criteria:

1. Presence of other severe comorbidities; 2. Incomplete clinical or follow-up data. The clinicopathological characteristics and Trop2 expression levels in tissue samples were compared between the ^131I treatment-responsive group and the ^131I treatment-resistant group.

Within the ^131I treatment-resistant group, comparisons were made between the rapidly progressing subgroup and the stable-disease subgroup under TSH-suppressive therapy in terms of clinicopathological features, tissue Trop2 expression levels, and SUVmax of metastatic lesions on ^18F-Trop2 PET-CT imaging. Factors influencing progression-free survival and overall survival in ^131I-resistant patients were analyzed.

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Key information

Conditions

PTC I-131 Trop2

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Jiangxi Cancer Hospital

Nanchang, Jiangxi, 330000, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

( 1) History of total thyroidectomy with postoperative pathology confirming papillary thyroid carcinoma (PTC); (2) At least one course of ^131I internal radiotherapy. Exclusion Criteria:(1) Presence of other severe comorbidities; (2) Incomplete clinical or follow-up data.

Treatment and study plan

radioiodine-131 therapy

Radiation

surgery, tsh inhibition therapy

Primary outcomes

  1. Tumor size;

    Time frame: 6-60 months

    Lesion size was determined using CT imaging. Lymph nodes were assessed based on their shortest diameter, while other target lesions were evaluated based on their longest diameter. Each measurable lesion underwent an average measurement derived from a minimum of three readings, with all measurements conducted by the same individual to minimize measurement discrepancies. Response Evaluation Criteria in Solid Tumors (RECIST 1.1) were used to assess treatment response

Secondary outcomes

  1. Serological assessment

    Time frame: 1-60months

    Including serum thyroglobulin (Tg) and serum anti-thyroglobulin antibody levels (TgAb) in thyrotropin-inhibited states, as well as tumor markers such as CEA

Sponsors and collaborators

Lead sponsor

Jiangxi Provincial Cancer Hospital

Other

Collaborators

  • Jingxiu Zhong
  • Lin Zhou
  • Tianzhu Lu
  • Yu Su
  • Zhijun Chen

Registry information

Acronym: ZL2025

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 2, 2026
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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