3 Tesla Magnetic Resonance Guided High Intensity Focused Ultrasound in the Treatment of Pain From Bone Metastases of Solid Tumors

NCT02718404 | Terminated

• 1 other identifier: IRST198.01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effectiveness of the Philips Sonalleve 3 Tesla MR-HIFU device for treating painful bone metastases.

Conditions

Solid Tumors

Keywords

MR-HIFU; bone metastases; pain treatment

Outcome Measures

Primary Outcomes (1)

• Pain response

  multidimensional score: the Brief Pain Inventory

  up to 90 days after study treatment

Secondary Outcomes (9)

• Time to pain palliation

  up to 30 days after study treatment

• Time to pain progression

  up to 30 days after study treatment

• Duration of pain palliation

  up to 30 days after study treatment

• Recording of pain medication

  24 hours before study treament

• Quality of Life on the EORTC-QLQ-C15-PAL scale12

  0, 3, 7, 14 and 30 days following treatment, and additionally at 60 and at 90 days if the subject has not been referred to an alternative local treatment

Study Arms (1)

MR-HIFU Treatment

EXPERIMENTAL

The Philips MR-HIFU Sonalleve System integrates a high intensity phased array focused ultrasound transducer with a 3 Tesla Magnetic Resonance (MR) imaging system and electromechanical transducer positioning system to deliver spatially and temporally controlled ultrasound energy and thermal heat to tissues non-invasively. At HIFU day (day 0) before treatment patient will be performed a bone lesion MRI and a functional brain MRI. During the treatment procedure, an intravenous catheter will deliver MR contrast media and medications (such as sedation and analgesics if required) within the MR room. Following the MR-HIFU procedure, a set of MR images of the target region will be acquired with the use of a MR contrast agent, together with a functional brain MRI.

Procedure: MR-HIFU Treatment; Drug: MR contrast media and medications; Procedure: MR images

Interventions

MR-HIFU Treatment PROCEDURE

The Philips MR-HIFU Sonalleve System integrates a high intensity phased array focused ultrasound transducer with a 3 Tesla Magnetic Resonance (MR) imaging system and electromechanical transducer positioning system to deliver spatially and temporally controlled ultrasound energy and thermal heat to tissues non-invasively. At HIFU day (day 0) before treatment patient will be performed a bone lesion MRI and a functional brain MRI.

MR-HIFU Treatment

MR contrast media and medications DRUG

During the treatment procedure, an intravenous catheter will deliver MR contrast media and medications (such as sedation and analgesics if required) within the MR room.

Also known as: sedation, analgesics

MR-HIFU Treatment

MR images PROCEDURE

Following the MR-HIFU procedure, a set of MR images of the target region will be acquired with the use of a MR contrast agent, together with a functional brain MRI.

MR-HIFU Treatment

Eligibility Criteria

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

You may qualify if:

• Radiologic evidence of bone metastases (BM) from any solid tumors in patients with age ≥ 18 years
• Patient capable of giving informed consent and able to attend study visits
• All target lesion (s) at intended treatment site accessible for MR-HIFU Distance Skin-lesion (target) \> 1 cm
• Patient has 1-3 painful lesions, and only the most painful lesion will be treated
• Weight \< 140 Kg
• Intended target volume visible by non-contrast MRI
• Patient able to characterize pain at site of target lesion (s), before and after the procedure.
• MR-HIFU treatment date ≥ 2 weeks from last local treatment of the target lesion

You may not qualify if:

• Planned treatment lesion is a primary bone tumor Patient enrolled in another clinical study related to bone metastases treatment or pain relief treatment
• Unable to tolerate required stationary position during treatment
• Need for surgical stabilization in case of (impending) fracture (lytic lesion in weight-bearing bone larger than 50% of bone diameter)
• Pregnant woman
• Pain related to target lesion is predominantly due to fracture or impending fracture
• Pain related to target lesion is due to involvement of a neighboring major nerve by the metastatic tumor (cord or nerve compression)
• Target \< 3cm from bladder / bowel / nerve along the beam path and \< 1cm in the plane orthogonal to the beam
• Target in contact with hollow viscera
• Target located in skull, joints, ribs (when HIFU beam overlapping with lung), spine (excluding sacrum which is allowed) or sternum.
• Scar along proposed HIFU beam path
• Internal or external fixation device along the proposed HIFU beam path or at the target
• MRI contraindicated (e.g. paramagnetic implants, pacemaker, claustrophobia)
• MRI contrast agent contraindicated (e.g. previous anaphylaxis or glomerular filtration rate \< 30 ml/min/1.73m2)
• Sedation contraindicated
• Clinically relevant medical history or abnormal physical findings that could interfere with the safety of the participant as judged by the treating physician or investigator.

Sponsors & Collaborators

• Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS: lead

Study Sites (1)

Centro di Osteoncologia e Tumori Rari (CDO-TR) IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) S.r.l

Meldola, FC, 47014, Italy

Location

MeSH Terms

Conditions

Agnosia

Interventions

Dosage Forms; Analgesics

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Toni Ibrahim, MD

  IRST IRCCS

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2016
• First Posted: March 24, 2016
• Study Start: September 14, 2015
• Primary Completion: July 4, 2018
• Study Completion: August 27, 2018
• Last Updated: June 30, 2022

Record last verified: 2022-05

Locations

IT (1)