Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06362772
Status:
COMPLETED
Last Update Posted:
2024-04-12
First Post:
2024-04-01
Brief Title:
Clinical Efficacy of 125I Seed Implantation in the Treatment of Refractory Differentiated Thyroid Cancer
Sponsor:
Jiangxi Provincial Cancer Hospital
Organization:
Jiangxi Provincial Cancer Hospital
Study Overview
Official Title:
The Clinical Value of Iodine-125 Seed Implantation in the Treatment of Iodine-refractory Differentiated Thyroid Carcinoma
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 80120 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 260 Pairwise comparisons were conducted using the Wilcoxon signed-rank test and a p-value of less than 005 indicated statistical significance
Detailed Description:
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 11 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 260 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 005
This study was approved by the Ethics Committee of Jiangxi Provincial Cancer Hospital
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 11 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 260 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 005
This study was approved by the Ethics Committee of Jiangxi Provincial Cancer Hospital
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None