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

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ClinicalTrials.gov Identifier: NCT03152695
Recruitment Status : Recruiting
First Posted : May 15, 2017
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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.

Condition or disease Intervention/treatment Phase
Symptomatic Abdominal Tumour Device: High-intensity focused ultrasound Not Applicable

Detailed Description:

The clinical recommendations for unresectable malignant tumors, which cause pain and other symptoms, are chemotherapy or local radiation therapy to delay tumor progression, improve life quality and prolong survival, while there is no other effective recommendations for benign tumors., Local ablation, such as radiofrequency ablation (RFA), is expected to be another therapeutic option for tumors that cannot be surgically resected. However, the main drawback of radiofrequency ablation is that its puncture invasion can sometimes cause bleeding or tumor metastasis. The peripheral blood vessels can also cause poor ablation, therefore; RFA is limited to small liver cancer treatment.

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.

Under the real-time magnetic resonance imaging system and a variety of appropriate scanning to move the focused ultrasound in the treatment area to kill the tumor. The tumor that is killed will gradually absorb and fibrosis in the body. There is no significant invasion due to it is without penetrating the needle into body. This system has been approved and certificated for the use of soft tissue ablation by Taiwan Food and Drug Administration (TFDA) in 2016. The main participants of this study are patients who have benign and malignant tumors in the abdominal cavity with tumor-related symptoms and not suitable for surgical resection. The investigators will conduct HIFU, observe whether there is any complications after surgery. Moreover, the investigators will notice the tumor response after a month and track the survival rate to verify the feasibility and advantages of HIFU for clinical use.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: To Evaluate the Safety and Efficacy of High-intensity Focused Ultrasound (HIFU) for the Symptom Relief of Inoperable Abdominal Tumors
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: High-intensity focused ultrasound therapy
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
Local tumor ablation by ArcBlate (EpiSonica, Taiwan) will be performed, and the entire procedure will be monitored by MRI




Primary Outcome Measures :
  1. Evaluation of tumour response [ Time Frame: 1 month after treatment ]
    Evaluation of tumour response according to the modified RECIST criteria by sequencing CT or MR imaging


Secondary Outcome Measures :
  1. To evaluate the overall survival [ Time Frame: within one year ]
    using Common Terminology Criteria for Adverse Events (CTCAE). Version 4.0 and overall survival



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-

Patients must meet all of the following inclusion criteria to be eligible for this study:

  1. Eligible patients with symptomatic intra-abdominal tumor including liver, pancreas, bile duct and retroperitoneal tumors will be enrolled for study.
  2. The criteria for unresectability included evidence of distant metastatic disease, involvement of the major vessels and high risk of functional insufficiency after tumor excision.
  3. Eastern Cooperative Oncology Group (ECOG) score of 0-1,
  4. American Society of Anaesthesiologists (ASA) score ≤ 3,
  5. 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
  6. Prior Informed Consent Form
  7. Life expectancy of at least 3 months.

Exclusion Criteria:

  • Patients presenting with any of the following will not be enrolled into this study:

    1. The tumor cannot be visualized by abdominal MRI.
    2. No suitable approach route for ultrasound toward tumor under image evaluation, for example scar formation, bowel gas, bone within the ultrasound window.
    3. Women who are pregnant.
    4. The patients had received treatment with an investigational agent/ procedure within 30 days prior to this study.
    5. Arterial calcification was noted within the treatment window of ultrasound.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03152695


Contacts
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Contact: Kai-Wen Huang, MD, PhD +886-23123456 cubewu@gmail.com

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Kai-Wen Huang, MD, PhD       skywing@ntuh.gov.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Kai-Wen Huang, MD, PhD National Taiwan University Hospital

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03152695     History of Changes
Other Study ID Numbers: 201701032DIPD
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: January 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Abdominal Neoplasms
Neoplasms by Site
Neoplasms