Pain Relief in Symptomatic Bone Metastases With Adjuvant Hyperthermia MR Guided HIFU

NCT05167669 | Completed DMC

• 1 other identifier: 2020-02998
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Metastatic disease to the bone is a common cause of pain. External beam radiation therapy (EBRT) is the standard palliative treatment BUT pain improvement is observed in 60% to 80%. Combination of hyperthermia (HT) with radiation is strongly compelling. MR is providing accurate, tissue-independent thermometry for intra-procedural guidance of thermal therapy. In this project we aim to combine in an adjuvant setting mild hyperthermia to EBRT for sustained relief of pain in patients with symptomatic bone metastases.

Conditions

Bone Metastases; Radiotherapy; Pain; MRI

Keywords

BONE METASTASES, PAIN, MRI, HIFU, RADIOTHERAPY

Outcome Measures

Primary Outcomes (2)

• Accurate elevation of temperature measured by MRI thermometry (degree celsius)

  Accurate control of spatio-temporal pixel-wise MR thermometry (several hundred pixels): spatial homogeneity of temperature elevation within the tumour and inter-patient reproducibility (expected standard deviation of 0.5°C).

  day 1

• Safety and patient tolerance according to The adverse events (CTCAE v5.0) (Art. 2 Abs 58 MDR)

  Safety and patient tolerance: no adverse effects in surrounding bone and soft tissues, compliance with one-day dual treatment during the first month. Dermatitis of grade 3 or more - Pain of skin grade 3 * Skin atrophy grade 3 * Localized edema of grade 3 * Bone fracture of grade 3 or more

  day 1

Secondary Outcomes (4)

• Complete pain response according to International Bone Metastases Consensus Endpoint score (BPI score)

  at 28 days after EBRT + HT

• Pain assessment using Brief Pain Inventory score (BPI score)

  at day 1, day 7, and 28 days after treatment after EBRT + hyperthermia.

• quality of life using EORTC QLQ-C15-PAL (bone metastases module) questionnaires.

  day 1, day 7, and 28 days after EBRT + hyperthermia.

• quality of life using EORTC QLQ-BM22 (bone metastases module) questionnaires.

  day 7, and day 28 after EBRT + hyperthermia.

Study Arms (1)

Prospective, interventional, single-center, feasibility pilot study.

OTHER

10 patients with radiologically confirmed bone metastases and eligible for a course of palliative EBRT. Eligible patients will be mainly discussed and recruited in a dedicated tumor-board for bone metastases performed in a weekly basis at HUG.

Device: HIFU-MRI guided

Interventions

HIFU-MRI guided DEVICE

HIFU application under MRI guiding to deliver hypothermia to eligible bone metastases before clinical indicated radiotherapy

Prospective, interventional, single-center, feasibility pilot study.

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven cancer;
• cancer-related pain corresponding to a site (or sites) of radiologically confirmed bone metastases with a severity score of at least 2 out of 10 according to the Brief Pain Inventory (NRS scale);
• age ≥ 18 years;
• indication for a palliative course of EBRT;
• osteolytic or mixed (osteoblastic/osteolytic) bone metastases ≤ 5 cm in the largest diameter; target tumours accessibility for device (ribs, extremities, pelvis, shoulders or posterior aspects of spinal vertebra) and at least 1 cm from skin and major nerve bundles;

You may not qualify if:

• Inability to provide a written informed consent;
• Karnofsky performance status (KPS) \< 60; presence of clinical or radiological evidence of spinal cord compression, a pathological fracture, or an impending fracture needing surgical fixation;
• previous EBRT to study site (or sites);
• participation in another clinical trial and any concurrent treatment with any investigational drug within 4 weeks prior to trial entry;
• inability to comply with study and follow up procedures;
• patients having metal implants, pacemakers or clustered markers non-MR compatible

Sponsors & Collaborators

• Sana Boudabbous: lead

Study Sites (1)

University Hospitals of Geneva

Geneva, 1205, Switzerland

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD PD HEAD OF MUSCULOSKELETAL UNITY- RADIOLOGY DIVISION- DIAGNOSIS DEPARTMENT

Model Details: Number of participants: 10 patients with radiologically confirmed bone metastases and eligible for a course of palliative EBRT. Eligible patients will be mainly discussed and recruited in a dedicated tumor-board for bone metastases performed in a weekly basis at HUG.

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 22, 2021
• Study Start: October 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: January 1, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

CH (1)