Clinical Efficacy of 125I Seed Implantation in the Treatment of Refractory Differentiated Thyroid Cancer

NCT06362772 | Completed

• 1 other identifier: MR-36-24-010944
• Study Type: observational
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

A retrospective analysis was conducted on RAIR-DTC patients who underwent radioactive 125I seed implantation from January 2015 to February 2022 at Jiangxi Cancer Hospital. Prescription dose: 80\~120 Gy. All cases were followed up at 1, 3, and 5 months postoperatively to monitor changes in tumor size, serum thyroglobulin (Tg), and serum anti-thyroglobulin antibody levels in thyrotropin-inhibited states, pain scores, and postoperative adverse reactions. The data were processed and analyzed using IBM SPSS 26.0. Pairwise comparisons were conducted using the Wilcoxon signed-rank test, and a p-value of less than 0.05 indicated statistical significance.

Conditions

Thyroid Neoplasms

Keywords

Iodine-125 particles; Brachytherapy; Iodine-refractory differentiated thyroid carcinoma; Thyroid Neoplasms

Outcome Measures

Primary Outcomes (4)

• Tumor size

  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\[1\].

  Patients were evaluated preoperatively and at 1, 3, and 5 months postoperatively.

• Serological assessment

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

  Patients were evaluated preoperatively and at 1, 3, and 5 months postoperatively.

• Pain score

  Use the Visual Analogue Scale to record patients' pain scores. The scale ranges from 0 to 10 points, with pain increasing incrementally. 0 indicates no pain, 1-3 indicate mild pain that is still tolerable and does not interfere with sleep or normal life, 4-6 indicate moderate pain that interferes with sleep and requires analgesic medication to alleviate it, and 7-10 show intense and intolerable pain that seriously interferes with sleep and diet and requires strong analgesic drugs.

  Patients were evaluated preoperatively and at 1, 3, and 5 months postoperatively.

• Adverse event

  Postoperative adverse reactions, including infection, bleeding, pneumothorax, bone marrow suppression, and seed displacement, were recorded. Radiation injury was graded according to the Radiation Therapy Oncology Group (RTOG) and European Organization for Research and Treatment of Cancer (EORTC) toxicity criteria \[2\].

  Assess within six months after surgery.

Study Arms (1)

125I seed implantation treatment group

125I seed implantation treatment group

Radiation: Iodine-125 brachytherapy

Interventions

Iodine-125 brachytherapy RADIATION

In advance of the surgery, patients were informed about their condition, the expected efficacy of 125I seed implantation therapy, alternative treatments such as external beam radiotherapy and chemotherapy, as well as potential side effects and toxic effects. The preoperative evaluation process includes assessments of coagulation function, liver and kidney function, cardiopulmonary function, and local CT scans. A collaborative effort between physicians and physicists was undertaken to establish a treatment regimen with a prescription dose ranging from 80 to 120 Gy. The patient accepted the treatment plan and signed an informed consent form. The CT-guided 125I seed implantation procedure was conducted according to the prescribed treatment regimen. Efficacy evaluations were conducted at pre-surgery, 1-, 3-, and 5-month post-surgery. The evaluations focused on lesion dimensions, serum Tg, TGAb, TSH levels, pain levels, and adverse reactions.

125I seed implantation treatment group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A retrospective analysis was conducted on Iodine-Refractory Differentiated Thyroid Cancer (RAIR-DTC) patients who underwent radioactive 125I seed implantation from January 2015 to February 2022 at Jiangxi Cancer Hospital.

Sponsors & Collaborators

• Jiangxi Provincial Cancer Hospital: lead

Related Publications (4)

• Watanabe H, Okada M, Kaji Y, Satouchi M, Sato Y, Yamabe Y, Onaya H, Endo M, Sone M, Arai Y. [New response evaluation criteria in solid tumours-revised RECIST guideline (version 1.1)]. Gan To Kagaku Ryoho. 2009 Dec;36(13):2495-501. Japanese.

  PMID: 20009446 BACKGROUND

• Cox JD, Stetz J, Pajak TF. Toxicity criteria of the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC). Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1341-6. doi: 10.1016/0360-3016(95)00060-C. No abstract available.

  PMID: 7713792 BACKGROUND

• Chen Z, Tang X, Tan L, Su Y, Wang W, Wu Z. Efficacy and safety of anlotinib combined with 125I seed implantation for iodine-refractory thyroid cancer. Front Endocrinol (Lausanne). 2025 Aug 22;16:1587412. doi: 10.3389/fendo.2025.1587412. eCollection 2025.

  PMID: 40917344 DERIVED

• Wan Q, Tan L, Tang X, Wang W, Su Y, Wu Z, Ke M, Chen Z. The clinical value of iodine-125 seed implantation in the treatment of iodine-refractory differentiated thyroid carcinoma. Front Endocrinol (Lausanne). 2024 Apr 15;15:1327766. doi: 10.3389/fendo.2024.1327766. eCollection 2024.

  PMID: 38686207 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Only blood samples were retained to monitor the patient's serum thyroglobulin (Tg), serum anti-thyroglobulin antibody, and thyrotropin (TSH) levels.

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Zhijun Chen

  Jiangxi Provincial Cancer Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 12, 2024
• Study Start: January 1, 2015
• Primary Completion: February 1, 2022
• Study Completion: April 1, 2023
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share