High-intensity Focused Ultrasound (HIFU) for the Symptom Relief of Inoperable Abdominal Tumors

NCT03152695 | Unknown

• 1 other identifier: 201701032DIPD
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

High-intensity focused ultrasound (HIFU), a recently developed tumor ablation equipment, can be a non-invasive treatment for solid tumors. The principle of HIFU is physically focus the ultrasound point on the biological tissue to form high-intensity ultrasound focus, and kill tumor cells by the thermal effects, mechanical effects and acupuncture effects of the high-intensity ultrasound.

Conditions

Symptomatic Abdominal Tumour

Outcome Measures

Primary Outcomes (1)

• Evaluation of tumour response

  Evaluation of tumour response according to the modified RECIST criteria by sequencing CT or MR imaging

  1 month after treatment

Secondary Outcomes (1)

• To evaluate the overall survival

  within one year

Study Arms (1)

High-intensity focused ultrasound therapy

EXPERIMENTAL

Abdominal MRI will be used to target the tumor, and the tumor will be divided into slices with 5mm separation using MR images. By scanning the HIFU beam in successive sweeps from the deep to the shallow regions of the tumor.

Device: High-intensity focused ultrasound

Interventions

High-intensity focused ultrasound DEVICE

Local tumor ablation by ArcBlate (EpiSonica, Taiwan) will be performed, and the entire procedure will be monitored by MRI

High-intensity focused ultrasound therapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible patients with symptomatic intra-abdominal tumor including liver, pancreas, bile duct and retroperitoneal tumors will be enrolled for study.
• The criteria for unresectability included evidence of distant metastatic disease, involvement of the major vessels and high risk of functional insufficiency after tumor excision.
• Eastern Cooperative Oncology Group (ECOG) score of 0-1,
• American Society of Anaesthesiologists (ASA) score ≤ 3,
• Adequate bone marrow, liver and renal function (1). Platelet count ≥ 100 K/Μl(2). Total bilirubin ≦ 5 mg/dL(3). Alanine transaminase (ALT) and aspartate transaminase (AST) \< 5 x upper limit of normal (4). Prothrombin time (PT)- international normalized ratio (INR) ≦ 2.0 (5). Serum creatinine ≦ 2 x upper limit of normal
• Prior Informed Consent Form
• Life expectancy of at least 3 months.

You may not qualify if:

• Patients presenting with any of the following will not be enrolled into this study:
• The tumor cannot be visualized by abdominal MRI.
• No suitable approach route for ultrasound toward tumor under image evaluation, for example scar formation, bowel gas, bone within the ultrasound window.
• Women who are pregnant.
• The patients had received treatment with an investigational agent/ procedure within 30 days prior to this study.
• Arterial calcification was noted within the treatment window of ultrasound.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Study Officials

• Kai-Wen Huang, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kai-Wen Huang, MD, PhD

CONTACT

+886-23123456; cubewu@gmail.com

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: May 11, 2017
• First Posted: May 15, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 29, 2017

Record last verified: 2017-01

Locations

TW (1)