Feasibility of Combined Focused Ultrasound and Radiotherapy Treatment in Patients With Painful Bone Metastasis

NCT04310410 | Completed Phase 1

• 1 other identifier: NL68441.041.19
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

The PRE-FURTHER study aims to evaluate the feasibility of the combined treatment with radiotherapy and focussed ultrasound for pain palliation in patients with painful bone metastases, and to optimize the combined treatment logistics. Six to ten patients will be included according to in- and exclusion criteria.

Conditions

Bone Metastases; Bone Neoplasm; Bone Lesion; Bone Cancer; Pain; Cancer Induced Bone Pain; Radiation Toxicity; Quality of Life; Tumor; Neoplasm Metastasis

Keywords

Bone metastases; Cancer Induced Bone Pain; Pain palliation; Radiotherapy; Radiation oncology; MR-HIFU; MRI-guided high intensity focused ultrasound; Focused ultrasound; HIFU

Outcome Measures

Primary Outcomes (2)

• Feasibility of combined treatment with EBRT and MR-HIFU - Patient tolerance: questionnaire

  The main outcome of this study is the feasibility of the combined procedure in terms of patient tolerance and hospital logistics. Patient tolerance will be assessed using a Patient Reported Experience Measure questionnaire.

  4 weeks

• Feasibility of combined treatment with EBRT and MR-HIFU - hospital logistics

  The main outcome of this study is the feasibility of the combined procedure in terms of patient tolerance and hospital logistics. Hospital logistics will be assessed by analysing comments of the treating physicians and research staff on the problems that occurred during treatment planning, and whether extra hospital visits that were needed.

  4 weeks

Secondary Outcomes (2)

• Patient reported pain scores.

  at 3 days, and at 1, 2, 3 and 4 weeks

• (Serious) adverse events

  at 3 days, and at 1, 2, 3 and 4 weeks

Study Arms (1)

Combined Focused Ultrasound and Radiotherapy

EXPERIMENTAL

Combination of focused ultrasound and external beam radiotherapy

Combination Product: combined radiotherapy and MR-HIFU

Interventions

combined radiotherapy and MR-HIFU COMBINATION_PRODUCT

Following standard EBRT (single or multiple fraction), patients will receive one MR-HIFU treatment with the Profound Sonalleve MR-HIFU device on the most painful of their bone metastases. This treatment will take place in a short time frame of 3 hours to maximum 4 days. Patients will be followed up until 4 weeks after treatment. During follow-up they will be phoned around day 3, 7, 14, 21 and 28 to retrieve pain scores, pain medication and (serious) adverse events. At day 3 the patient's experience with the combined treatment will also be inquired.

Combined Focused Ultrasound and Radiotherapy

Eligibility Criteria

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

You may qualify if:

• Men and women with age ≥ 18 years
• Patient capable of giving informed consent and able to attend study visits
• Uncomplicated painful bone metastases
• Weight \<140kg and able to fit in the MRI gantry
• Radiologic evidence of bone metastases from any solid tumor
• Pain is localized to the targeted area, or is likely to be referred pain arising from the targeted area
• Pain related to the target lesion is refractory to less invasive treatments for pain relief
• Multiple metastatic lesions, with one predominantly painful lesion (\>=2 points higher pain score than other lesions). The lesion should be clearly distinguishable from other painful lesions.
• Device accessible tumors: extremities (excluding joints), pelvis, shoulders, posterior vertebral spine below L5, in selected cases ribs and sternum
• Target lesion maximum dimension ≤ 8cm
• Intended target volume visible by non-contrast MR imaging
• Distance between target and skin ≥ 1cm
• Numeric Rating Scale (NRS) score \>= 4 or equivalent
• Life expectancy \>3 months

You may not qualify if:

• Planned treatment lesion is a primary bone tumor or due to lymphoma, multiple myeloma, or leukemia.
• Communication barrier present
• Patient enrolled in another clinical study related to bone metastases treatment or pain relief treatment
• Unable to tolerate required stationary position during treatment despite adequate pain medication
• Need for surgery
• 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 in most cases sternum
• 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 \< 20 ml/min/1.73m2)
• Sedation contraindicated

Sponsors & Collaborators

• UMC Utrecht: lead
• Isala: collaborator

Study Sites (2)

Isala Klinieken Zwolle

Zwolle, Overijsel, 8025 AB, Netherlands

Location

University Medical Center Utrecht

Utrecht, 3508GA, Netherlands

Location

MeSH Terms

Conditions

Bone Neoplasms; Pain; Radiation Injuries; Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Bone Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Neoplastic Processes; Pathologic Processes

Study Officials

• Helena M Verkooijen, MD, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective case series (n = 6 - 10), stage I and IIA study according to the Innovation, Development, Evaluation, Assessment and Long term evaluation (IDEAL) recommendations. The study will be performed in male and female adult (≥ 18 years) cancer patients capable of giving informed consent and referred for EBRT of painful bone metastases (Numerical Rating Scale (NRS) ≥ 4).

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: March 17, 2020
• Study Start: April 11, 2019
• Primary Completion: April 1, 2020
• Study Completion: June 1, 2020
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

NL (2)