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

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05167669

Studienbeginn:
Oktober 2022

Letztes Update:
04.12.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Neoplasm Metastasis, Bone Neoplasms, Bone Marrow Diseases, Hyperthermia

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
Frühphase (Phase 0)

Sponsor:
Sana Boudabbous

Collaborator:
-

Kontakt

sana boudabbous, MD PD
Kontakt:
Phone: 0041795532444
E-Mail: sana.boudabbous@hcuge.ch» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University Hospitals of Geneva
1205 Geneva
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Sana Boudabbous, Dr
E-Mail: sana.boudabbous@hcuge.ch» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

Metastatic disease to the bone is a common cause of pain and other significant symptoms with

a detrimental impact into quality of life. Up to 85% of the patients dying from breast,

prostate, or lung cancer present bone metastases. External beam radiation therapy (EBRT) is

one of the standard palliative treatment modalities effective in palliating painful bone

metastases. Using patient-based evaluation method, pain improvement is observed in 60% to 80%

of the patients, with 15% to 40% complete pain relief. Combination of hyperthermia (HT) with

radiation is strongly compelling as it is based on principles of classic radiobiology,

molecular biology, and tumor physiology. Elevating temperature to a supra-physiological level

(between 41° and 43°) shows a complementary action when combined with RT with regard to cell

killing. Magnetic resonance (MR) imaging is commonly used in clinical routine for

radiological diagnostic and staging. Moreover, 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. Ex vivo studies for the adaptation of existing

MR-guided focused ultrasound (MRgFUS) device were already conducted at University Hospitals

of Geneva to the current application demonstrating the high accuracy of the technique for

mild hyperthermia treatments. A clinical prospective, interventional, single-center pilot

feasibility study will be conducted to assess the clinical application of this technique.

Primary objective

1. 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).

2. Safety and patient tolerance: no adverse effects in surrounding bone and soft tissues,

compliance with one-day dual treatment during the first month.

Secondary objectives

1. Complete pain response at 28 days after EBRT + HT based on the International Bone

Metastases Consensus Endpoint definition.

2. Pain assessment for the worst pain related to the treated lesion using the Brief Pain

Inventory score at baseline, at day 1, day 7, and 28 days after treatment after EBRT +

hyperthermia.

3. Health-related quality of life evaluated using self-administered EORTC QLQ-C15-PAL and

EORTC QLQ-BM22 (bone metastases module) questionnaires at baseline, day 7, and day 28

after EBRT + hyperthermia.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- • 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;

Exclusion Criteria:

- 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

Studien-Rationale

Primary outcome:

1. Accurate elevation of temperature measured by MRI thermometry (degree celsius) (Time Frame - day 1):
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).

2. Safety and patient tolerance according to The adverse events (CTCAE v5.0) (Art. 2 Abs 58 MDR) (Time Frame - day 1):
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

Secondary outcome:

1. Complete pain response according to International Bone Metastases Consensus Endpoint score (BPI score) (Time Frame - at 28 days after EBRT + HT):
Complete pain response based on the International Bone Metastases Consensus Endpoint definition.

2. Pain assessment using Brief Pain Inventory score (BPI score) (Time Frame - at day 1, day 7, and 28 days after treatment after EBRT + hyperthermia.):
Pain assessment for the worst pain related to the treated lesion using the Brief Pain Inventory score

3. quality of life using EORTC QLQ-C15-PAL (bone metastases module) questionnaires. (Time Frame - day 1, day 7, and 28 days after EBRT + hyperthermia.):
Health-related quality of life evaluated using self-administered EORTC QLQ-C15-PAL (bone metastases module) questionnaires

4. quality of life using EORTC QLQ-BM22 (bone metastases module) questionnaires. (Time Frame - day 7, and day 28 after EBRT + hyperthermia.):
Health-related quality of life evaluated using self-administered EORTC QLQ-BM22 (bone metastases module) questionnaires

Geprüfte Regime

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

Quelle: ClinicalTrials.gov

Sie können folgenden Inhalt einem Kollegen empfehlen:

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

Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.

Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!