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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2023-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Treatment Efficacy and Safety of Low-dose Radioiodine Ablation for Intermediate-risk Differentiated Thyroid Carcinoma

NCT04354324

Papillary Thyroid Cancer

RECRUITING NA

Lesion Dosimetry With 124-Iodine in Metastatic Thyroid Carcinoma

NCT00673010

Thyroid Cancer

COMPLETED PHASE1

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

NCT07314255

PTC I-131 Trop2

ACTIVE_NOT_RECRUITING

Comparison of I-124 PET/CT for the Diagnosis of Thyroid Cancer

NCT06961084

Thyroid Cancer

RECRUITING PHASE2

Differentiated Thyroid Cancer Patients Treated With Different Doses of Radioactive Iodine.

NCT06134830

Thyroid Cancer

NOT_YET_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Data from RAIR-DTC patients hospitalized at Jiangxi Cancer Hospital from January 2015 to February 2022 were retrospectively collected.

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 thyroglobulin (Tg), TG antibodies (TGAb), thyroid-stimulating hormone (TSH) levels, pain levels, and adverse reactions.

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) \[1\] were used to assess treatment response. Use the Visual Analogue Scale to record patients' pain scores. 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 \[2\].

The data were analyzed using IBM SPSS 26.0. The count data (n%) and skewed measures \[Md (Q1, Q3)\] are presented. Group comparisons were conducted using the paired Wilcoxon rank-sum test, with statistical significance set at P \< 0.05.

This study was approved by the Ethics Committee of Jiangxi Provincial Cancer Hospital.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Thyroid Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

125I seed implantation treatment group

Iodine-125 brachytherapy

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Iodine-125 brachytherapy

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.

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Inclusion Criteria: Differentiated Thyroid Cancer (DTC) was confirmed by pathology, with local recurrence or distant metastasis of residual thyroid cancer and conforming to any of the following Iodine-Refractory Differentiated Thyroid Cancer (RAIR-DTC) criteria: (1) no uptake of 131I in the initial 131I treatment; (2) loss of iodine uptake capacity in previously functional iodine-avid lesions; (3) disease progression after 131I therapy, including gradual enlargement of the lesion and continuously increasing levels of serum thyroglobulin (Tg).

Exclusion Criteria: Patients with severe physical diseases, such as severe dysfunction of the cardiac, pulmonary, hepatic, or renal systems, poor compliance, inability to tolerate 125I seed implantation, severe acute infectious or chronic infection with acute exacerbation, severe coagulopathy that may lead to serious complications like infection or bleeding, pregnant or lactating women affecting fetal and infant growth and development, patients with cachexia or expected survival of ≤3 Months and patients with positive serum anti-thyroglobulin antibodies (TgAb) that may impact the assessment of treatment efficacy.

Eligible Sex

ALL

Accepts Healthy Volunteers

No