New computer model aims to make cancer bone implants safer and more effective
NCT ID NCT07171996
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study tests a new way to plan radioactive seed implants for people with cancer that has spread to the bones. The new method uses a computer model to help doctors place the seeds more precisely, aiming to improve pain relief and lower the risk of bone fractures or seeds moving. The trial will compare this new planning method to the standard approach in 150 participants.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- radioactive seed implantation (I-125)
- What this could lead to
- If successful, this planning method could improve pain relief and reduce bone fractures and other complications for people with cancer that has spread to the bones.
- What could go wrong
- This is an early-stage trial testing a new planning approach, not a new treatment. The method may not prove better than standard planning, and results may not apply to all patients or cancer types.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥18 years. Radiologically or histologically confirmed bone metastasis with a lesion suitable for percutaneous radioactive seed implantation (e.g., I-125), per multidisciplinary assessment. Indication for local palliation/control: moderate-to-severe pain at lesion (e.g., BPI/VAS ≥4) and/or imaging evidence of progression or high-risk features warranting local therapy. Measurable/evaluable target lesion on CT/MRI; target location accessible for needle placement per institutional practice. ECOG performance status 0-2. Estimated life expectancy ≥3 months. Adequate hemostasis: platelets ≥80×10\^9/L, INR ≤1.5 (or per protocol), and able to hold/bridge anticoagulation as clinically indicated. Adequate organ function to undergo the procedure and anesthesia/sedation per site standards. Able to undergo required imaging (CT; MRI if applicable). Willing and able to provide written informed consent and comply with follow-up. For women of childbearing potential and men with partners of childbearing potential: agreement to use effective contraception during and for the protocol-defined period after implantation. Exclusion Criteria: * Need for urgent surgical decompression or stabilization (e.g., acute/impending neurologic compromise, unstable pathologic fracture) that precludes percutaneous implantation at this time. Uncorrected coagulopathy or ongoing antithrombotic therapy that cannot be safely managed periprocedurally. Active systemic or local infection at/near the planned access route. Diffuse marrow replacement or extensive cortical destruction where percutaneous implantation is unsafe or unlikely to achieve local control without stabilization, per MDT judgment. Prior radiation or surgery to the index lesion that, in the investigator's opinion, makes additional seed implantation unsafe or non-beneficial; postoperative bed without a discrete target for seed placement. Known hypersensitivity to materials/agents required for the procedure (e.g., contrast) not amenable to premedication or alternative imaging. Uncontrolled medical conditions posing prohibitive procedural risk (e.g., severe cardiopulmonary disease, uncontrolled hypertension/arrhythmia). Pregnant or breastfeeding. Inability to lie still or contraindications to required imaging/sedation not correctable. Concurrent participation in another interventional study that could confound efficacy/safety assessment at the treated site. Any condition that, in the investigator's judgment, would interfere with protocol adherence, safety monitoring, or outcome assessment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The 960 Hospital of the People's Liberation Army of China
RECRUITINGJinan, Shandong, 250031, China
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