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MR-Guided Focused Ultrasound vs Radiotherapy for Bone Metastases Pain Relief

Q: Are there any open slots currently available for this research endeavor?

<p>As indicated on clinicaltrials.gov, recruitment for this study is not currently taking place. The trial was established on January 1st 2023 and last modified November 9th 2022, yet there are 679 other studies seeking patients at the moment.</p>

N/A

Waitlist Available

Led By Pejman Ghanouni, MD, PhD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Painful metastatic bone lesions, with NRS > 4 documented at screening visit

Target lesion location is accessible for MR-HIFU and EBRT

Timeline

Screening 3 weeks

Treatment Varies

Follow Up on baseline, at 2 and 4 weeks, and at 3 and 6 months

Awards & highlights

Study Summary

This trial is testing whether MR HIFU or EBRT is better at treating painful bone metastases.

Who is the study for?

Adults with painful bone metastases from cancer, who can distinguish pain from a specific lesion and have an NRS score >4. The target lesion must be visible on recent imaging, no larger than 8 cm, and accessible for treatment. Participants should have a life expectancy over 3 months, reasonable health status (KPS >50% or ECOG <3), and be able to consent.Check my eligibility

What is being tested?

The study compares MR-guided high intensity focused ultrasound (MR HIFU) with external beam radiation therapy (EBRT) for relieving pain in patients with bone metastases. It's randomized, meaning participants are assigned by chance to either treatment group.See study design

What are the potential side effects?

Potential side effects of MR HIFU include discomfort during the procedure, skin burns or bruising at the treatment site. EBRT might cause skin irritation, fatigue, mild swelling or more serious complications depending on the area treated.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have painful bone lesions from cancer with a pain score over 4.

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My cancer can be reached for specific non-invasive treatments.

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I can tell my target lesion pain apart from other pains.

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I can take care of myself but may not be able to do active work.

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I am 18 years old or older.

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I have one or more painful bone lesions from cancer, with one being significantly more painful.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ on baseline, at 2 and 4 weeks, and at 3 and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~on baseline, at 2 and 4 weeks, and at 3 and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and on baseline, at 2 and 4 weeks, and at 3 and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants that achieve a complete response (CR) or partial response (PR)

Secondary outcome measures

Anxiety and depression scores

Local tumor control

Pain

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: MR guided high intensity focused ultrasound (MR-HIFU)Experimental Treatment1 Intervention

MRHIFU treatment will be delivered using the ExAblate 2100 System (INSIGHTEC, Tirat Carmel, Israel), which is an FDA-approved device for pain palliation of bone metastases.

Group II: External beam radiation therapy (EBRT)Active Control1 Intervention

Patients will undergo radiotherapy for painful bone metastases.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,393 Previous Clinical Trials

17,341,186 Total Patients Enrolled

Pejman Ghanouni, MD, PhDPrincipal InvestigatorStanford University

2 Previous Clinical Trials

5 Total Patients Enrolled

Media Library

Bone Metastases Clinical Trial 2023: External beam radiotherapy Highlights & Side Effects. Trial Name: NCT05250687 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open slots currently available for this research endeavor?

"As indicated on clinicaltrials.gov, recruitment for this study is not currently taking place. The trial was established on January 1st 2023 and last modified November 9th 2022, yet there are 679 other studies seeking patients at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

MR Guided Focused Ultrasound vs Radiotherapy for Palliative Pain Tx in Bone Metastases

2024. "MR Guided Focused Ultrasound vs Radiotherapy for Palliative Pain Tx in Bone Metastases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05250687.

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