CT-guided Radioactive Iodine-125 Seed Implantation for Recurrent Desmoid Tumors

NCT06195085 | Completed DMC

• 1 other identifier: RID
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to explore the long-term outcomes of CT-guided radioactive iodine-125 (I-125) seed implantation (RISI) for recurrent desmoid tumor. A multicenter retrospective study reviewed 38 recurrent desmoid tumor patients receiving RISI from July 2013 to July 2021.The clinical outcomes including overall response rate (ORR), disease control rate (DCR), local control time (LCT), overall survival (OS), adverse events (AEs), and symptom relief rate were statistically assessed.

Conditions

Brachytherapy; Desmoid Tumor; Radioactive Iodine-125 Seed Implantation

Outcome Measures

Primary Outcomes (3)

• Local control time (LCT)

  LCT was defined as the time from seed implantation to local progression

  8 years

• objective response rate (ORR)

  ORR was calculated from patients achieving CR and PR

  6 months

• disease control rate (DCR)

  DCR was likewise calculated from the patients of CR, PR and SD.

  6 months

Secondary Outcomes (3)

• overall survival (OS)

  8 years

• adverse events (AEs)

  8 years

• symptom relief rate

  8 years

Study Arms (1)

CT-guided radioactive iodine-125 seed implantation

The patients, diagnosed with recurrent desmoid tumor, undergoing CT-guided radioactive iodine-125 seed implantation in 3 different centers including Peking University Third Hospital, First Affiliated Hospital of the Army Medical University, and Shengli Oilfield Central Hospital from July 2013 to July 2021.

Radiation: CT-guided radioactive iodine-125 seed implantation

Interventions

CT-guided radioactive iodine-125 seed implantation RADIATION

The CT-guided radioactive iodine-125 seed implantation procedure mainly consisted of preoperative treatment planning, intraoperative seed implantation and postoperative dosimetric evaluation. All procedures were performed as per relevant guidelines and regulations.

CT-guided radioactive iodine-125 seed implantation

Eligibility Criteria

• Age: 13 Years - 75 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patients, diagnosed with recurrent desmoid tumor, undergoing RISI in 3 different centers including Peking University Third Hospital, First Affiliated Hospital of the Army Medical University, and Shengli Oilfield Central Hospital from July 2013 to July 2021 were reviewed consecutively.

You may qualify if:

• \) recurrent desmoid tumor confirmed by pathologic or imaging diagnosis; 2) disease size ≥1 cm and ≤ 10 cm; 3) medically inoperable or individual refusal to resection; 4) Karnofsky performance status (KPS) ≥ 60; 5) adequate hematological reserves, hepatic function, renal function and heart function; 7) expected survival \> 3 months.

You may not qualify if:

• \) unconfirmed mass; 2) tumor invading the skin or mucous membrane; 2) patients with severe bleeding tendency; 3) patients with active infectious disease, trauma and severe wounds; 4) patients with any mental disorder; 5) patients with other somatic comorbidities of clinical concern; 6) pregnancy and lactation

Sponsors & Collaborators

• Peking University Third Hospital: lead
• First Affiliated Hospital of the Army Medical University: collaborator
• Shengli Oilfield Hospital: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Desmoid Tumors

Condition Hierarchy (Ancestors)

Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Junjie Wang, M.D.

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 8, 2024
• Study Start: July 1, 2013
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2023
• Last Updated: January 8, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Always

Locations

CN (1)