Image-Guided 125I Seed Implantation Plus Standard Systemic Therapy for Patients With Multiple Metastatic Lesions

NCT07333664 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 960HP20251220
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with more than five and up to ten metastatic lesions often have limited tolerance for surgery, radiotherapy, or thermal ablation because of cumulative treatment burden or expected toxicity. In this setting, systemic therapy alone frequently remains the primary treatment option. This prospective, open-label, randomized phase 2 study evaluates whether image-guided iodine-125 (125I) seed implantation, when added to standard-of-care systemic therapy, can improve disease control compared with standard systemic therapy alone in patients with multiple metastatic lesions. Clinical outcomes including progression-free survival, overall survival, safety, and quality of life will be prospectively assessed.

Conditions

Metastatic Solid Tumors

Keywords

Multiple Metastases; lodine-125 Seed Brachytherapy; Image-Guided Therapy

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  Progression-free survival is defined as the time from randomization to disease progression or death from any cause, whichever occurs first. Disease progression will be assessed using RECIST version 1.1 and/or PERCIST criteria, based on the baseline imaging modality.

  From randomization up to 12 months

Secondary Outcomes (5)

• Overall Survival (OS)

  From randomization up to 24 months

• Time to Initiation of a New Systemic Therapy (TTNT)

  From randomization up to 12 months

• Local Control of Treated Lesions

  From intervention up to 12 months

• Safety and Treatment-Related Adverse Events

  From intervention through 12 months

• Quality of Life (QoL)

  Baseline, and 6 months

Other Outcomes (1)

• Patterns of Disease Progression

  From the date of randomization until the date of first documented disease progression, assessed up to 24 months.

Study Arms (2)

Standard-of-Care Systemic Therapy

ACTIVE COMPARATOR

Participants receive standard-of-care systemic anticancer therapy according to current clinical guidelines and treating physician discretion.

Other: Standard-of-Care Systemic Therapy

125I Seed Implantation plus Standard-of-Care Systemic Therapy

EXPERIMENTAL

Participants receive image-guided iodine-125 (125I) seed implantation to multiple metastatic lesions in combination with standard-of-care systemic anticancer therapy.

Other: Standard-of-Care Systemic Therapy; Procedure: Iodine-125 (125I) Seed Implantation

Interventions

Iodine-125 (125I) Seed Implantation PROCEDURE

Image-guided implantation of iodine-125 (125I) radioactive seeds to multiple metastatic lesions for local tumor control, performed under CT guidance (with PET/CT fusion planning when clinically indicated) according to institutional standards.

125I Seed Implantation plus Standard-of-Care Systemic Therapy

Standard-of-Care Systemic Therapy OTHER

Systemic anticancer therapy administered according to current clinical guidelines and treating physician discretion, which may include chemotherapy, immunotherapy, targeted therapy, and/or maintenance therapy.

125I Seed Implantation plus Standard-of-Care Systemic Therapy; Standard-of-Care Systemic Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Histologically or cytologically confirmed malignant solid tumor with metastatic disease.
• Presence of more than five and up to ten (6-10) extracranial metastatic lesions, identified on CT or PET/CT imaging and assessable by RECIST version 1.1 (and/or PERCIST when PET imaging is used).
• At least one metastatic lesion considered suitable for image-guided iodine-125 (125I) seed implantation according to institutional assessment.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Adequate organ function to undergo interventional procedures and systemic therapy, as determined by institutional standards.
• Ability to understand and willingness to provide written informed consent.

You may not qualify if:

• Diffuse or unstable central nervous system involvement, including leptomeningeal disease or uncontrolled/symptomatic brain metastases requiring immediate local intervention.
• Medical conditions that preclude safe interventional procedures, including uncontrolled infection, severe cardiopulmonary dysfunction, or other serious systemic illness, as judged by the investigator.
• Contraindications to percutaneous implantation, such as uncorrectable coagulation disorders, high bleeding risk, lack of a safe needle path, or unacceptable risk to critical organs.
• Pregnancy or breastfeeding.
• Inability to provide informed consent or comply with study procedures, due to severe psychiatric illness, cognitive impairment, or other limiting conditions.
• Any other condition that, in the investigator's judgment, would make the patient unsuitable for study participation or compromise patient safety or study integrity.

Sponsors & Collaborators

• Li Min: lead

Study Sites (1)

The 960th Hospital of People's Liberation Army (PLA)

Jinan, Shandong, 250031, China

Location

MeSH Terms

Interventions

Iodine-125

Central Study Contacts

Min Li, M.D.

CONTACT

0531-51665482; liminyingxiang.@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the interventional nature of iodine-125 (125I) seed implantation, participants and treating clinicians are not blinded to treatment allocation. However, radiologists and nuclear medicine physicians who assess imaging outcomes are masked to treatment assignment, and imaging data are reviewed using anonymized datasets to minimize assessment bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice Director

Model Details: This is a randomized, parallel-assignment interventional study with two treatment arms. Participants are assigned in a 1:1 ratio to receive either standard-of-care systemic therapy alone or image-guided iodine-125 (125I) seed implantation plus standard-of-care systemic therapy.

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 12, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Individual participant data (IPD) will be available beginning 6 months after publication of the primary study results and will remain available for 5 years following publication, or until the main study database is closed, whichever occurs first.
• Access Criteria: Qualified researchers affiliated with academic institutions or recognized research organizations may request access to de-identified individual participant data (IPD), including imaging-derived parameters, dosimetric results, and clinical outcome data.Requests must include a brief research proposal describing the scientific rationale, objectives, and planned analyses. Approval will be granted by the study's principal investigator and institutional ethics committee. Data will be shared through secure institutional data transfer systems after execution of a formal data sharing agreement that ensures patient confidentiality and compliance with applicable privacy regulations.

Locations

CN (1)