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The Safety and Efficacy of High-intensity Focused Ultrasound Ablation for Desmoid Tumors

The Safety and Efficacy of High-intensity Focused Ultrasound Ablation for Desmoid Tumors

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100041838
Enrollment
Unknown
Registered
2021-01-07
Start date
2021-01-11
Completion date
Unknown
Last updated
2021-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Desmoid Tumor

Interventions

Treatment Group:High-intensity Focused Ultrasound Ablation (HIFUa)

Sponsors

Chongqing Haifu Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Patients with a pathologically confirmed diagnosis of DT by thick needle puncture or surgical resection; (2) patients with symptomatic DTs, or patients with asymptomatic DTs with progression after active surveillance or conservative therapy, or patients with recurrent DTs after surgical resection and strong treatment requirements; (3) patients with tumors that could be visualized on ultrasound; and (4) patients with a tumor depth greater than 1.5 cm from the skin surface.

Exclusion criteria

Exclusion criteria: (1) The total cumulative dose of radiotherapy exceeded 45 Gy, or local skin in the acoustic pathway had become hard and fibrous due to previous radiotherapy; (2) the presence of extensive scars (>1.5 cm in width, >1.0 cm in height from skin) with obvious acoustic attenuation in the acoustic pathway; (3) ruptured skin and soft tissues in the tumor region, unhealed defects and local infection; (4) DTs with important nerve wrapping; (5) patients who were unable to maintain the treatment position for 1 hour; (6) patients with diseases of vital organs; (7) patients allergic to imaging contrast agents; (8) patients with contraindications for sedation and analgesia; and (9) pregnant and lactating patients.

Design outcomes

Primary

MeasureTime frame
Non-perfused Volume Rate (NPVR);Progression-free Survival (PFS);

Secondary

MeasureTime frame
Incidence of Tumor Ablation;Complete Response (CR);Partial Response (PR);Stable Disease (SD);Progressive Disease (PD);

Countries

China

Contacts

Public ContactWen-Zhi Chen

State Key Laboratory of Ultrasound in Medicine and Engineering, College of Biomedical Engineering, Chongqing Medical University

chenwz@cqmu.edu.cn+86 23-68485021

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026